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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Industrial Biotest Laboratory was found to use fraudulent practices in some of their studies and reports. Since these studies were performed before the implementation of Good Laboratory Practices, it is not possible to verify the scientific credibility of most of these studies.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1961
Report Date:
1961

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
OECD 401 requires 5 animals/sex Body weight data of surviving animals not reported. Report does not indicate whether survivors were necropsied.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
tert-dodecyl mercaptan, purity not noted

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals and environmental conditions:
No data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
6.83, 10.25, 15.38, 23.07 g/kg (volumes not specified; test substance supplied as liquid)
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
Young albino rabbits, New Zealand strain, were selected as the test animals. The undiluted test material was applied to the shaved backs of four rabbits in each of four groups at dose levels of 6.83, 10.25, 15.38 and 23.07 g/kg of body weight and covered with an occlusive wrapper. After 24 hours of contact, test compound was washed off and the rabbits were observed for 14 days.

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
12 600 mg/kg bw
Mortality:
All eight of the mid-high (15.38 g/kg) and high dose (23.07 g/kg) group animals died on test.  They displayed gradually progressive loss of appetite and weakness. Death occurred three to four days post-dosing. 
Clinical signs:
No untoward effects were noted in any low dose group animals. Mild inactivity lasting up to 36 hours post-dosing was  observed in the 10.25 g/kg dose group. 
Gross pathology:
Necropsy findings were unremarkable, other than the skin reactions, in animals that died on test.
Other findings:
Local skin reactions were limited to a moderate erythema and discoloration of the skin at the test substance application site.  These reactions occurred throughout all dose groups, and in survivors, disappeared 72 to 96 hours post-dosing.

Applicant's summary and conclusion

Executive summary:

Young albino rabbits, New Zealand strain, were selected as the test animals. The undiluted test material was applied to the shaved backs of four rabbits in each of four groups at dose levels of 6.83, 10.25, 15.38 and 23.07 g/kg of body weight and covered with an occlusive wrapper. After 24 hours of contact, test compound was washed off and the rabbits were observed for 14 days.

The acute percutaneous LD50 is considered to be 12.6 g/kg of body weight in albino rabbits. Gross toxic signs consisted of inactivity, loss of appetite and weakness. Local skin reactions at the application site consisted of moderate erythema and discoloration of the skin. Death occurred three to four days after application of the test material. At necropsy no gross pathological findings, other than the skin reactions, were noted.