Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Seven Day Skin Irritation study in Rabbits
Author:
Eastman Kodak co.
Year:
1986
Bibliographic source:
TSCATS: OTS 0510692; cited in OECD SIDS "Isobutanol", Final September 2004
Reference Type:
secondary source
Title:
Unnamed
Year:
1986

Materials and methods

Principles of method if other than guideline:
Rabbits were exposed to isobutanol for 7 d to determine the skin irritation potential after repeated dermal exposition.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Isobutanol

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified

Administration / exposure

Type of coverage:
occlusive
Duration of treatment / exposure:
24 h per application
Frequency of treatment:
4-6 x 24 hr
Doses / concentrations
Dose / conc.:
0.3 other: mL undiluted test compound
No. of animals per sex per dose:
no data
Control animals:
no
Details on study design:
Post-exposure period: 72 hr

Results and discussion

Effect levels

Key result
Dose descriptor:
other: local toxicity
Basis for effect level:
other: highly irritant after repeated exposure under occlusive conditions; no systemic toxicity reported
Remarks on result:
not measured/tested

Any other information on results incl. tables

Four to 6 times repeated 24-hr occlusive exposure to 0.3 ml isobutanol caused severe edema and erythema with eschar formation, which persisted throughout the 72-hr post-observation period. Isobutanol was therefore judged to be "highly irritant”.

Applicant's summary and conclusion