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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
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:
Comparison of Behavioral Teratogenic Effects of Ethanol an N-Propanol administered by Inhalation to Rats
Author:
Nelson B.K., Brightwell W.S., Burg J.R
Year:
1985
Bibliographic source:
Neurobehavioral Toxicology and Teratology, Vol. 7, 779-783
Reference Type:
publication
Title:
Behavioral Teratology Investigation of 1-Propanol Administered by Inhalation to Rats
Author:
Nelson B.K., Brightwell W.S., Taylor B.J., Khan A., Burg J.R., Krieg E.F., Massari V.J.
Year:
1989
Bibliographic source:
Neurotoxicol.Teratol. 11, 153-159

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: other
Principles of method if other than guideline:
Male animals were treated for 42 days, then mated with untreated virgin females . Resulting pregnant females were sham exposed on gestation days 1-19 (experiment 1). Another group of untreated males and females were mated. Resulting pregnant females were then exposed to the test substance on gestation days 1-19 (experiment 2).
GLP compliance:
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):
whole body
Vehicle:
air
Duration of treatment / exposure:
Experiment 1
- Males : 6 weeks premating
- Females: sham exposed


Experiment 2
- Males: sham exposed
- Females: day 1-19 of gestation
Frequency of treatment:
7 h/day. 7 days/week.
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/m³ air (nominal)
Dose / conc.:
8 730 mg/m³ air (nominal)
Dose / conc.:
17 460 mg/m³ air (nominal)
Dose / conc.:
24 940 mg/m³ air (nominal)
No. of animals per sex per dose:
female 15; male 18

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. 8 730 mg/m³ air (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: Based on the reversible fertility effects

Results: F1 generation

Effect levels (F1)

Key result
Dose descriptor:
NOAEC
Generation:
F1
Effect level:
ca. 3 500 ppm (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs

Overall reproductive toxicity

Key result
Reproductive effects observed:
no
Lowest effective dose / conc.:
8 730 mg/m³ air
Treatment related:
no

Applicant's summary and conclusion