Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it was conducted according to or similar to now existing guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Observation period was only 7 days rather than the recommended 14 day duration.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
male

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: none
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
10
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

Any other information on results incl. tables

Initial skin contact evoked a severe pain reaction which coincided with a slight darkening in the color of the skin, none of the treated animals showed any toxic symptoms and all gained body weight during the subsequent period of observation. None of animals died following the test substance administration

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 was determined to be >2000 mg/kg bw (Latven, 1977).
Executive summary:

In a key acute dermal toxicity study, 10 male albino WBS/W rats were dermally administered ethanethiol (ethyl mercaptan) at doses of 2000 mg/kg bw (Latven, 1977). The test material was applied to clipped trunks under an impervious sleeve for a period of 24 hours and the animals were subsequently observed for 7 days.

There was no mortality observed through the study period but initial skin contact with the test material produced a mild pain reaction that was accompanied by dark discolouration of the skin. There were no other treatment-related effects observed through the study. The acute dermal LD50was determined to be >2000 mg/kg bw.

This study received a Klimisch score of 2 and is classified as reliable with restrictions because it adheres closely to OECD guideline but does not follow GLP.