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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was classified as reliable with restrictions because it was an acceptable, well-documented study report which meets basic scientific principles.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 49CFR173.240
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
ethyl mercaptan, purity not specified
- Name of test material (as cited in study report): ethyl mercaptan (Ethanethiol)
- Physical state: liquid
- Other: clear and colourless

Test animals

Species:
rabbit
Strain:
other: albino

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 0.845 g/mL
Duration of treatment / exposure:
4 hour(s)
Observation period:
3 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: trunk
- Type of wrap if used: gauze patch

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: overnight
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 hours
Score:
0
Max. score:
4

Any other information on results incl. tables

Initial skin contact evoked a mild pain reaction, when exposures were  terminated at four hours, moderate erythema (score 2) was present at all  of the treated sites; this
dissipated completely overnight. No other signs of skin irritancy could be discerned.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information (Not Classified) Criteria used for interpretation of results: EU
Conclusions:
Ethanethiol was found to be slightly irritating to the skin of rabbits, but this irritation was not sufficient to trigger classification (Latven, 1977).
Executive summary:

In a key primary dermal irritation study (Latven, 1977), six albino rabbits were dermally exposed to 0.5 millilitres of ethanethiol under occlusive wrap for 4 hours. The animals were subsequently observed for a period of 3 days.

Initial skin contact was found to elicit a mild pain reaction and moderate erythema (2) was observed at all treated sites at the end of the 4-hour exposure period. However, erythema was reversible and observed to have dissipated completely by the following morning. No other signs of treatment-related irritation or toxicity were observed. Ethanethiol was not considered to be a dermal irritant.

This study received a Klimisch score of 2 and is classified as reliable with restrictions because it was an acceptable study report which meets basic scientific principles.