2-methylbut-3-en-2-ol

Toxicity to reproduction

Administrative data

Endpoint:

screening for reproductive / developmental toxicity

Remarks:

based on test type (migrated information)

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study, data taken from secondary sources

Data source

Reference

Reference 1

Reference Type:

secondary source

Title:

Fragnance material review on 2-methyl-3-buten-2-ol

Author:

McGinty D. et al.

Year:

2010

Bibliographic source:

Food and Chemical Toxicology, 48, 97-100

Reference 2

Reference Type:

secondary source

Title:

OECD SIDS, CAS No. 115-18-4, 2-Methyl-3-buten-2-ol, May 2005

Year:

2005

Bibliographic source:

UNEP Publications

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-methylbut-3-en-2-ol

EC Number:

204-068-4

EC Name:

2-methylbut-3-en-2-ol

Cas Number:

115-18-4

Molecular formula:

C5H10O

IUPAC Name:

2-methylbut-3-en-2-ol

Details on test material:

- Analytical purity: 97.2 %

Test animals

Species:

rat

Strain:

other: Fü-Albino (RORO)

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Duration of treatment / exposure:

Exposure period: approx. 54 days
Premating exposure period (males): 2 weeks
Premating exposure period (females): 2 weeks

Frequency of treatment:

daily

Doses / concentrations

Remarks:

Doses / Concentrations:
12.5, 50 and 200 mg/kg/day
Basis:
actual ingested

No. of animals per sex per dose:

20

Control animals:

yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

Details on results (P0)

The male body weights tended to be reduced at 200 mg/kg/day, but were unaffected at 12.5 or 50 mg/kg/day, when compared to the concurrent controls. The female body weights were comparable among all experimental groups during premating, gestation and lactation. There were no compound-related abnormal clinical signs in any sex, apart from a slightly increased incidence of 'pasty faeces' at 200 mg/kg/day in males and females, during and after the mating period. During the premating period the mean food consumption did not differ considerably in both sexes between treated groups and controls. During the lactation period no biologically relevant effects on the female food consumption was observed up to 50 mg/kg/day, whereas there was a slight compound-related decrease at 200 mg/kg/day (mean and median values). There were no parental necropsy observations considered to be compound-related.
The mating and fertility indices of males and females were comparable in all experimental groups. The mean mating time (i.e. the number of mating days until day 0 of gestation) was slightly prolonged at 50 mg/kg/day only. Between treated groups and controls there were no biologically relevant differences in the reproduction parameters measured (mean numbers of: corpora lutea, implantations, pups per litter; resorption rates, mean gestation lengths, mean pup weights, pup sex ratios). The testes weights were not adversely affected in any of the dose groups.

Effect levels (P0)

Dose descriptor:

NOAEL

Effect level:

50 mg/kg bw/day

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: decrease in male body weight/gain; decrease in female food consumption during lactation; clinical signs

Results: F1 generation

Details on results (F1)

At 200 mg/kg/day the pup viability index was reduced by nearly 23 % (i.e. the number of pups dying during lactation was increased and the number of pups surviving day 5 of lactation was decreased). There were no compound-related adverse clinical findings in the pups in any of the dose groups. Pup body weight at birth and weight development until sacrifice was comparable between treated groups and concurrent controls. No abnormal findings were observed at the macroscopic external examination of the pups in any experimental group. The visceral examination of the pups of the control (stillborn and died) and the high dose group (all pups) did not indicate any compound-related adverse effects on the morphological development of the offspring.

Effect levels (F1)

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

50 mg/kg bw/day

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: reduced pup viability

Overall reproductive toxicity

Reproductive effects observed:

not specified