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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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Identification: Isooctyl thioglycolate (IOTG)
CAS no. 25103-09-7
Source: Elf Aquitaine production
Batch: TA 2511
Purity: 99.05 % (w/w)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The test item was applied to the skin of one group of ten Sprague-Dawley rats (five males and five females). The application was performed with the undiluted test item at the dose of 2000 mg/kg, taking into consideration that its specific gravity was 0.96 g/mL. The test site was then covered by a semi-occlusive dressing for 24 hours.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test item. All animals were subjected to necropsy.
Statistics:
Not appropriate

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: No death and clinical signs
Mortality:
No deaths occurred at 2000 mg/kg. 
Clinical signs:
The general behaviour and body weight gain of the animals were not affected by the treatment. No skin irritation was observed.
Body weight:
The body weight gain of the animals was normal.
Gross pathology:
A macroscopic axamination revealed no abnormalities in the animals sacrificed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

In an OECD 402 guideline study, undiluted IOTG was applied to the skin of ten Sprague-Dawley male and female rats at a dose of 2000 mg/kg.The test site was then covered by a semi-occlusive dressing for 24 hours. Clinical signs, mortality and body weight gain were checked for a period of 14 days and all animals were subjected to necropsy. No death occurred at 2000 mg/kg. No skin reactions were observed. Clinical signs and body weight gain were not affected by treatment. The LD0 for IOTG was greater than 2000 mg/kg bw.