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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
sub-chronic toxicity: dermal
Type of information:
other: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Justification for Read Across is provided in Section 13 of IUCLID

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Environmental Health Criteria 65: Butanols ā€“ Four Isomers: 1-Butanol 2-Butanol tert-Butanol Isobutanol
Author:
Patty, F.A.
Year:
1982
Bibliographic source:
Industrial Hygiene and Toxicology, 3rd ed., New York, Chichester, Brisbane, Toronto, Singapore, Wiley-Interscience. IIC: 4571-4578.
Reference Type:
secondary source
Title:
n-Butyl Alcohol CAS NĀ°: 71-36-3
Author:
OECD
Year:
2001
Bibliographic source:
OECD SIDS - ENEP Publication

Materials and methods

Principles of method if other than guideline:
Repeated applications to rabbits of 20 mL/kg bw/day for 30 days over a period of 6 weeks.
GLP compliance:
no
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Duration of treatment / exposure:
6 weeks
Frequency of treatment:
30 daily applications
Doses / concentrations
Dose / conc.:
20 other: mL/kg bw/day
No. of animals per sex per dose:
No data
Control animals:
not specified

Results and discussion

Results of examinations

Mortality:
no mortality observed

Effect levels

Dose descriptor:
NOAEL
Effect level:
20 other: mL/kg bw/day
Based on:
test mat.
Sex:
not specified
Remarks on result:
other: Mortality
Remarks:
No mortality observed during study period

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
NOAEL (dermal, sub-acute, rabbit) = 20 mL/kg bw/day
Executive summary:

The sub-chronic dermal toxicity of the substance was evaluated in an experimental study. Rabbits were exposed via the dermal route to 20 mL/kg bw/day of the test item for 30 days over a 6-week period.

No mortality or adverse signs of toxicity were recorded, therefore, the NOAEL was considered to be at least 20 mL/kg bw/day.