California Code of Regulations › Title 8 - Industrial Relations › Division 1 - Department of Industrial Relations › Chapter 4 - Division of Industrial Safety › Subchapter 7 - General Industry Safety Orders › Group 16 - Control of Hazardous Substances › Article 110 - Regulated Carcinogens › Appendix C - Medical Surveillance Guidelines for DBCP

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
I. Route of Entry
Inhalation; skin and eye absorption, ingestion.
II. Toxicology
Recent data collected on workers involved in the
						  manufacture and formulation of DBCP has shown that DBCP can cause sterility at
						  very low levels of exposure. This finding is supported by studies showing that
						  DBCP causes sterility in animals. Chronic exposure to DBCP resulted in
						  pronounced necrotic action on the parenchymatous organs (i.e., liver, kidney,
						  spleen) and on the testicles of rats at concentrations as low as 5 ppm. Rats
						  that were chronically exposed to DBCP also showed changes in the composition of
						  the blood, showing low RBC, hemoglobin, and WBC, and high reticulocyte levels
						  as well as functional hepatic disturbance, manifesting itself in a long
						  prothrombin time. Reznik et al. noted a single dose of 100 mg produced profound
						  depression of the nervous system of rats. Their condition gradually improved.
						  Acute exposure also resulted in the destruction of the sex gland activity of
						  male rats as well as causing changes in the estrous cycle in female rats.
						  Animal studies have also associated DBCP with an increased incidence of
						  carcinoma. Olson, et al. orally administered DBCP to rats and mice 5 times per
						  week at experimentally predetermined maximally tolerated doses. As early as ten
						  weeks after initiation of treatment, DBCP induced a high incidence of squamous
						  cell carcinomas of the stomach with metastases in both species, DBCP also
						  induced mammary adenocarcinomas in the female rats at both dose levels.
III. Signs and Symptoms
A. Airborne Exposure: Nausea, eye irritation,
						  conjunctivitis, respiratory irritation, pulmonary congestion or edema, CNS
						  depression with apathy, sluggishness, and ataxia.
B. Skin Contact: Erythema or inflammation and
						  dermatitis on repeated exposure.
IV. Special Tests
A. Semen analysis: The following information excerpted
						  from the document "Evaluation of Testicular Function," submitted by the
						  Corporate Medical Department of the Shell Oil Company (exhibit 39-3), may be
						  useful to physicians conducting the medical surveillance program;
In performing semen analyses certain minimal but
						  specific criteria should be met:
1. It is recommended that a minimum of three valid
						  semen analyses be obtained in order to make a determination of an individual's
						  average sperm count.
2. A period of sexual abstinence is necessary prior to
						  the collection of each masturbatory sample. It is recommended that intercourse
						  or masturbation be performed 48 hours before the actual specimen collection. A
						  period of 48 hours of abstinence would follow; then the masturbatory sample
						  would be collected.
3. Each semen specimen should be collected in a clean,
						  widemouthed, glass jar (not necessarily pre-sterilized) in a manner designated
						  by the examining physician. Any part of the seminal fluid exam should be
						  initiated
only after liquefaction
is complete, i.e., 30 to 45
						  minutes after collection.
4. Semen volume should be measured to the nearest 
						  1/10 of a
						  cubic centimeter.
5. Sperm density should be determined using routine
						  techniques involving the use of a white cell pipette and a hemocytometer
						  chamber. The immobilizing fluid most effective and most easily obtained for
						  this process is distilled water.
6. Thin, dry smears of the semen should be made for a
						  morphologic classification of the sperm forms and should be stained with either
						  hematoxylin or the more difficult, yet more precise, Papanicolaou
						  technique.
Also of importance to record is obvious sperm
						  agglutination, pyospermia, delayed liquefaction (greater than 30 minutes), and
						  hyperviscosity. In addition, pH, using nitrazine paper, should be
						  determined.
7. A total morphology evaluation should include
						  percentages of the following:
a. Normal (oval) forms,
b. Tapered forms,
c. Amorphous forms (include large and small sperm
						  shapes),
d. Duplicated (either heads or tails) forms, and
e. Immature forms.
8. Each sample should be evaluated for sperm
viability
(percent viable sperm moving at the time of
						  examination) as well as sperm
motility
(subjective
						  characterization of "purposeful forward sperm progression" of the majority of
						  those viable sperm analyzed) within two hours after collection, ideally by the
						  same or equally qualified examiner.
B. Serum determinations: The following serum
						  determinations should be performed by radioimmuno-assay techniques using
						  National Institutes of Health (NIH) specific antigen or antigen preparations of
						  equivalent sensitivity:
1. Serum follicle stimulating hormone (FSH);
2. Serum luteinizing hormone (LH); and
3. Serum total estrogen (females only).
V. Treatment
Remove from exposure immediately, give oxygen or
						  artificial resuscitation if indicated. Contaminated clothing and shoes be
						  removed immediately. Flush eyes and wash contaminated skin. If swallowed and
						  the person is conscious, induce vomiting. Recovery from mild exposures is
						  usually rapid and complete.
VI. Surveillance and Preventive Considerations
A. Other considerations. DBCP can cause both acute and
						  chronic effects. It is important that the physician become familiar with the
						  operating conditions in which exposure to DBCP occurs. Those with respiratory
						  disorders may not tolerate the wearing of negative pressure respirators.
B. Surveillance and screening. Medical histories and
						  laboratory examinations are required for each employee subject to exposure to
						  DBCP. The employer should screen employees for history of certain medical
						  conditions (listed below) which might place the employee at increased risk from
						  exposure.
1. Liver disease. The primary site of biotransformation
						  and detoxification of DBCP is the liver. Liver dysfunctions likely to inhibit
						  the conjugation reactions will tend to promote the toxic actions of DBCP. These
						  precautions should be considered before exposing persons with impaired liver
						  function to DBCP.
2. Renal disease. Because DBCP has been associated with
						  injury to the kidney it is important that special consideration be given to
						  those with possible impairment of renal function.
3. Skin disease. DBCP can penetrate the skin and can
						  cause erythema on prolonged exposure. Persons with pre-existing skin disorders
						  may be more susceptible to the effects of DBCP.
4. Blood dyscrasias. DBCP has been shown to decrease
						  the content of erythrocytes, hemoglobin, and leukocytes in the blood, as well
						  as increase the prothrombin time. Persons with existing blood disorders may be
						  more susceptible to the effects of DBCP.
5. Reproductive disorders. Animal studies have
						  associated DBCP with various effects on the reproductive organs. Among these
						  effects are atrophy of the testicles and changes in the estrous cycle. Persons
						  with pre-existing reproductive disorders may be at increased risk to these
						  effects of DBCP.
REFERENCES
1. Reznik, Ya. B. and Sprinchan, G. K.: Experimental
						  Data on the Gonadotoxic effect of Nemagon,
Gig. Sanit
., (6),
						  1975, pp. 101-102, (translated from Russian).
2. Faydysh, E. V., Rakhmatullaev, N. N. and
						  Varshavskii, V. A.: The Cytotoxic Action of Nemagon in a Subacute Experiment,
Med. Zh. Uzbekistana
, (No. 1), 1970, pp. 64-65, (translated
						  from Russian).
3. Rakhmatullaev, N. N.: Hygienic Characteristics of
						  the Nematocide Nemagon in Relation to Water Pollution Control,
Hyg.
						  Sanit.
, 36(3), 1971, pp. 344-348, (translated from Russian).
4. Olson, W. A.
et al:
Induction of
						  Stomach Cancer in Rats and Mice by Halogenated Aliphatic Fumigants,
Journal of the National Cancer Institute
, (51), 1973, pp.
						  1993-1995.
5. Torkelson, T. R. et al: Toxicologic Investigations
						  of 1,2 Dibromo-3-chloropropane,
Toxicology and Applied
						  Pharmacology
, 3, 1961, pp. 545-559.
1.
						  Editorial correction moving NOTE and HISTORIES 1-11 to precede Appendix A of
						  section 5212 (Register 99, No. 28). For
						  prior history of Appendices, see section
						  5212.