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Toxicological information

Toxicity to reproduction

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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

Reference
Name:
Unnamed
Type:
Constituent

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)