y 

' 

Consumer Product Testing 

Comparw In cor r;::tr<Hea 

Bldg No. 2-15B 

1275 Bloomfield Avenue 

Fairfield, New Jersey 07006 

(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 

8 
This report details : 

a dermal 1050 study in albino rabbits and 

an inhalation LC50 study in albino rats 

performed at the behest of : 

Saytech Inc, 

880 Main Street 

Sayreville, New Jersey 08872 

The test material, supplied by : 

Saytech Inc. 

was received on : 

September 15, 1978 

and identified as : 

GLS-S6-41A 

and was used as indicated in the Final Report 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 conditioned prior to use. Samples, raw data and final report copies 

are retained at these laboratories unless otherwise indicated. 

Project Director and study supervisor are signatory to this report. Date of 

submission is recorded on title page. Names of persons performing these tests are 

recorded on raw data sheets and laboratory log books and are available upon 

request. 
Range 

Final Report 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 (LD50l 

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. 
Final Report Summary 

DATE: November 7, 1978 

CLIENT: Saytech Inc. 

STUDY NO.: 78385-2 

REFERENCE NO.: 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/li teT (highest possible chamber 

concentration) for one hour, observed two weeks. Material 

used as x·ecei ved. 

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 Toxicity in 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 

prior to administration of the test material. 

Prior to determination of LD 50 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 during this period. 

Following the range finding the rabbits were dosed 

individually by dermal application under occluded patch 

at a dose level according to the results of the 14-day 

range finding previously performed. Applications were 

made to the clipped backs of six (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 libitum following 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. 

1

Hagan, 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 concentration of 200 

mg/1. Preconditioned supportive air was supplied at 

five (5) liters per minute, and the test material was 

presented from a dust generator to continue a 

nominal chamber concentration of 200 mg/Jiter air, 

over the one 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 

Find in 

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 

Body weight 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 and Sex 

8.0 1M 

2 Ma 

3 Ma 

4F 

5Fa 

6F 

a = abraded skin 

N =Normal 

D = Depression 

SD =Slight Depression 

XD = Severe Depression 

+ = Animal Death 

Table 2 

Saytech Inc. 

78385-2 

Page 9 

Acute Dermal Toxicity in 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 = Severe Depression 

+ = 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