Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was classified as reliable with restrictions because the test procedure was in accordance with national standard methods with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: US DoT guideline no. 49 CFR 173.240
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Source: Pennwalt Corporation
Batch: 803-TBM-76
Purity: no data

Test animals

Species:
rabbit
Strain:
other: Albino
Details on test animals and environmental conditions:
no data

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
8
Remarks on result:
other: No irritant effects of any kind were discernible at any of the treated skin sites

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
Conclusions:
In a skin irritation and corrosion study, 2-methylpropane-2-thiol was found to be not irritiating.
Executive summary:

In a skin irritiation and corrosion study (49 CFR 173.240), six albino rabbits (sex and strain unspecified) received 0.5mL of undiluted 2 -methylpropane-2-thiol (CAS # 75 -66 -1) applied to the intact skin site under standard gauze patches. The entire fur-clipped trunk of each animal was then covered with an impervious sleeve for a skin-contact period of 4 hours and then observed during 3 days. No signs of irritation were discernible at any of the six treated skin sites. The substance was classified as not irritating based on EC Regulation No 1272.

This study received a Klimisch score of 2 and was classified as reliable with restrictions because the test procedure was in accordance with national standard methods with acceptable restrictions.