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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Reference substance name:
Source Chemical 09
IUPAC Name:
Source Chemical 09
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.