Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
fertility, other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Lack of selective developmental toxicity of three butanol isomers administered by inhalation to rats
Author:
Nelson BK, Brightwell WS, Khan A, Burg JR, Goad PT
Year:
1989
Bibliographic source:
Fund Appl. Toxicol 12:469-479
Reference Type:
publication
Title:
Behavorial teratology investigation of 1-butanol in rats
Author:
Nelson BK, Brightwell WS, Robertson SK, Khan A, Krieg EF, Massarz VJ
Year:
1989
Bibliographic source:
Neurotoxicol Teratol 11:313-315

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: other
Principles of method if other than guideline:
Male SD rats (18/group) were exposed to concentration of 0, 3000, 6000 ppm 1-butanol for 6 weeks. The males were then mated to non-exposed females.
Separate groups of 15 pregnant females were exposed to the same concentrations from day 1 to 20 of gestation, and were allowed to deliver.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Butan-1-ol
EC Number:
200-751-6
EC Name:
Butan-1-ol
Cas Number:
71-36-3
Molecular formula:
C4H10O
IUPAC Name:
butan-1-ol

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure (if applicable):
not specified
Vehicle:
air
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
male: 6 weeks before mating
female: day 1 - 20 of gestation
Frequency of treatment:
7 h/day
Doses / concentrationsopen allclose all
Dose / conc.:
0 ppm
Dose / conc.:
3 000 ppm
Dose / conc.:
6 000 ppm
No. of animals per sex per dose:
female 15; male 18
Control animals:
yes

Results and discussion

Results: P0 (first parental generation)

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
no effects observed

Effect levels (P0)

Key result
Dose descriptor:
NOAEC
Effect level:
ca. 6 000 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: pregnancy rate

Results: F1 generation

Effect levels (F1)

Key result
Dose descriptor:
NOAEC
Generation:
F1
Effect level:
ca. 6 000 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
developmental neurotoxicity

Overall reproductive toxicity

Key result
Reproductive effects observed:
no
Lowest effective dose / conc.:
6 000 ppm
Treatment related:
no

Applicant's summary and conclusion

Conclusions:
The NOAEL for maternal and paternal animals, and their offspring was 6000 ppm (18189 mg/m3)