y ' 

# Consumer Product

# Testing Comparw Incorr;::tr<Hea Bldg No. 2-15B 1275 Bloomfield Avenue Fairfield, NewJersey07006 (201) 575-7688 (201)575-7689 Kemi!1alie Hand!. inspel<tionan 

### FINAL REPORT 

## Ink. 1996-03- 

## 2 CLIENT: Saytech Inc. 880 Main Street Sal<nr 

### Lc;:J 

### r.r



### ATTENTION:
TESTS:
TEST MATERIAL: EXPERIMENT REFERENCE NO. :

Date 

### November 7, 1978 

### ALP/CAL/nlm Sayreville, New Jersey 08872 LaVerne J
_Makfinsky Manager, Technical Compliance Inhalation LC50 

### (Rat) Dermal LD50 

### (Rabbit)
GLS-S6-41A

78.385-2

/'I I. 

## 'I ( _A'l/v\ .Ff( "!{.

**;~** .':"_) ,**~~--~~-L**(
. 

### Christine A. Lewis, B.S. Laboratory Supervisor Project Director 

# i'7j//- -·\

**I·.J~ ~_k··t_.·** ;-1 -::-,./ ·- l....- I i .,-A-,;1,:1'--e 

### n::'-cL;--.'P"a:-:1,-'=a"'nc;k:cc. e""r'--vv:= '·' -· · 

### President 

## 8This report details :

a dermal 1050 study in albino rabbits and an inhalation LC50 study in albino rats performedat the behestof : Saytech Inc, 880 Main Street Sayreville, New Jersey 08872 The test material, supplied by : Saytech Inc.
was receivedon : September 15, 1978 andidentifiedas : GLS-S6-41A

and was usedas indicatedin the FinalReport Summaries. Study Interval : September 28, 1978 to November 2, 1978 All a,nimals are fed and watered ad libitum; with Wayne animal feeds used exclusively. Animals are received from Summit View Farm, Belvidere, New Jersey and are conditionedprior to use. Samples, raw dataand final reportcopies are retainedatthese laboratoriesunless otherwiseindicated. Project Director and study supervisor are signatory to this report. Date of submissionis recorded on titlepage. Namesofpersonsperformingthesetests are recorded on raw data sheets and laboratory log books and are available upon request.

### Range FinalReport Summary 

# I

DATE: November 7, 1978 CLIENT: Saytech Ilic. STUDY NO.: 78385-2 REFERENCE NO.: P. 0. #0032.3 MATERIAL: GLS-S6-41A

Acute Dermal Toxicity (LD50

## l
Method: Following 14-day range finding, albino rabbits in groups of six

Result: (3M:3F), J, 

### abraded, 1.

### 88

- 2.07 kg, highest dose level mechanically possible, single application dermally under occluded patch, observed fourteen days. Material used as received, LD50 and 95% confidence limits according to the method of Litchfield and Wilcoxin, when possible. Upper limit possible due to mechanical and physical limitations is 8 g/kg.

LD50: > 

### 8 g/kg Dose Level (g/kg) 

### Sex /I

### dead//Idose<!_ % 

### Mortality 0.5 1F 0/1 0 Finding: 2.0 1F 0/1 0
Test Dosage: 5.0 1F 0/1 0 8.0 1F 0/1 0 8.0 3M:3F 0/3:0/.3 0

Not a toxic material dermally to rabbits under conditions of this test.
Consumer Product Testing Company, Inc.FinalReport Summary

DATE: 

### November 7, 

### 1978 CLIENT: 

### Saytech Inc. STUDY NO.: 

### 78385-2 REFERENCENO.: 

### P. 

### o. 1100323 MATERIAL: 

### GLS-S6-41A

Inhalation Lc50 Method: Albino rats in groups to ten (5M:5F), 233-292 g, exposed to concentrations of 200 mg/liteT (highest possible chamber concentration) for one hour, observed two weeks. Material used as x·eceived. Result: Lc50

Gross Dose Level (mg/1) 200 > 

### 200 mg/1 Sex 5M:SF Pathology: No gToss changes observed. #dead/lldosed 0/5:0/5 0



### Not a toxic mateTial by inhalation to Tats under conditions of this test.

Consumer Product Testing Company, Inc.METHOD: Acute Dermal Toxicityin

**Rabbit~** (LD50) 

### Saytech Inc. 78385-2 

### Page 5

Acute dermal toxicity in r4bbits was detelmined according to the procedures suggested by Hagah. New Zealand white rabbits, as indicated in the summary, were maintained under standard laboratory conditions priorto administration ofthe test material. Priorto determination ofLD50 single animals, skin unabraded, were dosed at various levels to determine a range within which the LD 0 could be determined. Animals were observed



### fou~een full days following application to determine mortality duringthis period. Following the range finding the rabbits were dosed individually by dermal application under occluded patch ata dose level according to the results of the 14-day range finding previously performed. Applications were made to the clipped backs ofsix (3M:3F) animals, J/2 abraded, under 1" x 1" gauze patches over 10% of the body surface. The dosed area was then covered with an impermeable plastic wrapping for 211 hours, after which it was removed and the skin gently cleansed. Animals were returned to quarters where food and water were available ad libitumfollowing the dose application. Animals were observed for signs of pharmacologic activity and drug toxicity at 1, 3, 6, and 24 hours postdosage. Observations were made daily thereafter to a total of fourteen days. Non-survivors and animals sacrificed at the end of the 111-day observation period were subjected to complete gross necropsy. LD 0 together with 95% confidence limits was determined,



### ~here possible, by the method of Litchfield and Wilcoxin. The highest dose mechanically feasible to use is considered to be 8 g(ml)/kg bodyweight. Doses as high as 20 g/kg are used when instructed under EPA regulations; however, the data derived at, at these extraordinary high levels cannot be deemed as accurate as that derived at, at the lower dose levels. 1Hagan, E.C. (1959) Acute Toxicity; Appraisal of the Safety of Chemicals m Foods, Drugs, and Cosmetics, pp. 17

- 25. 2utchfield, 

### J.T. and Wilcoxin, F. (19lt9) Acute Toxicity; J. Pharm. & Ex. Ther., pp. 96,

99.

### Inhalation LC50 in Rats Saytech Inc. 78385-2 Page 6



### A group of adult Wistar-derived albino rats as indicated in the summary, was housed in a threecubic-foot plastic chamber for the single one (1) 

### hour dynamic exposure period. The chamber was initially charged with test material at a concentrationof 200 mg/1. Preconditioned supportive air was supplied at five (5) liters per minute, and the test material was presentedfrom a dustgeneratorto continue a nominal chamber concentration of 200 mg/Jiter air, overtheone hour period. At the end of the one-hour period, the animals were returned to individual quarters and observed daily for two weeks after which time they were sacrificed and autopsied.

### RESULTS: Acute Dermal Toxicity in Rdbbits Saytech Inc. 78385-2 

### Page 7

Individual results are presented in Tables 1 & 

### 2. Acute Inhalation Toxicity Individual results are presented in Table .3. 

### Summaries of all results are found preceding the text.Range Findin Dose Animal Number g/kg and Sex 0.5 2.0 5.0 8.0 lF 2F 3F 4F

a =abraded skin N =Normal D =Depression SO =Slight Depression XD =Severe Depression + =Animal Death Table 1 Acute Dermal Toxicity in Rabbits
GLS-S6-41A Bodyweight Hours: Days: (kg) 1 3 6 24 2 3 1.95 N N N N N N 2.03 N 1.94 N NO CHANGES 2.25 N 

## I Saytech Inc. 78385-2 Page 8

Bodyweight 4 5 6 7--14 (kg) N N N N N 2.11 2.36 OBSERVED 2.28 2.51

Comments: Animal ill

- il4: Skin pliable and non-in·itated. No gr-oss changes observed. Draize Scor-es at 24 Hours: Animal ill 0/0 Animal #2 0/0 Animal il3 0/0 Animal il4 0/0

### Dose Animal Number g/kg 

### andSex 

### 8.0 1M 2Ma 3 

### Ma 

### 4F 5Fa 6F



### a =abradedskin N =Normal D =Depression SD =Slight Depression XD =SevereDepression + 

### =Animal Death Table 2 

### Saytech Inc. 78385-2 Page 9

AcuteDermal Toxicityin Rabbits
Bodyweight (kg)


### 1.98 1.88 1.98 2.00 2.07 2.06 GLS-S6-41A Hours: Days: Bodyweight 1 3 6 24 2 3 4 

### 5 6 7--14 

### (kg)


### N N N N N N N NN N N 2.52 N 2.38 N NO CHANGES OBSERVED 2.42 N 2.06 N 2.19 N 2.69

Conunents: Animal #1

- #6: No gross changes observed. Draize Scores at 24 Hours: Animal #1 0/0 Animal #2 0/0 Animal 11.3 

### 0/0 Animal #4 0/0 Animal 115 0/0 Animal 116 0/0

### Table 3 Acute Inhalation Toxicity GLS-S6-41A Dose Animal Number Bodyweight Hours: Days: mg/1 al1d Sex (grams) 

### I 3 6 

### 21! 2 

### 3 200 

### IM 284 N N N N N N 

### 2M 292 N 

### 3M 274 N 

### I!M 264 N lj 

### 5 

### N N Saytech Inc. 78.385-2 Page 10

Bodyweight 6 

### 7 --II! (grams) N N N 366 344 330 320 

### 5M 270 N NO CHANGES OBSERVED 284 6F 

### 7F 8F 9F 10 F



### N =Normal D =Depression SD =Slight Depression XD =SevereDepression + 

### = Animal Death 282 N 242 N 233 N 244 N 242 N

Comments; Animal #1

- #10: No gross chrutges observed. 370 278 268 276 268