Pentane-1,2-diol

Toxicity to reproduction

Administrative data

Endpoint:

screening for reproductive / developmental toxicity

Remarks:

based on test type (migrated information)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1994

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)

Deviations:

no

GLP compliance:

yes

Remarks:

Mitsubishi-Kasei Institute of Toxicological and Environmental Sciences, 14, Sunayama. Hazaki-machi, Kashima-gun, lbaraki, Japan.

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butane-1,2-diol

EC Number:

209-527-2

EC Name:

Butane-1,2-diol

Cas Number:

584-03-2

IUPAC Name:

butane-1,2-diol

Constituent 2

Reference substance name:

1,2 Butanediol

IUPAC Name:

1,2 Butanediol

Details on test material:

- Name of test material: 1,2 Butanediol
- Analytical purity: > 99%

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

no details give but stated to be in line with guideline OECD 422

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on exposure:

no details give but stated to be in line with guideline OECD 422

Details on mating procedure:

no details give but stated to be in line with guideline OECD 422

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

42 days for males.
37 days for females (Females were exposed from day 14 before mating to day 3 of lactation.)

Frequency of treatment:

once daily

Details on study schedule:

no details give but stated to be in line with guideline OECD 422

Doses / concentrations

Remarks:

Doses / Concentrations:
0 (negative control), 40, 200, or 1000mg/kg
Basis:
actual ingested

No. of animals per sex per dose:

10

Control animals:

yes, concurrent vehicle

Details on study design:

Daily oral gavage of 0 (negative control), 40, 200, or 1000mg/kg body weight/day for 42 days for males. Females were exposed from day 14 before
mating to day 3 of lactation. Study design was stated to be in line with Guide line OECD 422.

Examinations

Parental animals: Observations and examinations:

Study design was stated to be in line with Guide line OECD 422.

Oestrous cyclicity (parental animals):

Study design was stated to be in line with Guide line OECD 422.

Sperm parameters (parental animals):

Study design was stated to be in line with Guide line OECD 422.

Litter observations:

Study design was stated to be in line with Guide line OECD 422.

Postmortem examinations (parental animals):

Study design was stated to be in line with Guide line OECD 422.

Postmortem examinations (offspring):

Study design was stated to be in line with Guide line OECD 422.

Statistics:

Study design was stated to be in line with Guide line OECD 422.

Reproductive indices:

Study design was stated to be in line with Guide line OECD 422.

Offspring viability indices:

Study design was stated to be in line with Guide line OECD 422.

Results and discussion

Results: P0 (first parental generation)

Details on results (P0)

There were no death throughout the entire observation period. There were no visible differences in body weight, food consumption, hematology parameters, clinical chemistry parameters, organ weight, or pathological examination between the treated and control animals. No effect on reproduction were observed. There were no effects on die reproductive/developmental parameters of copulation, implantation, pregnancy, parturition, and lactation.

Effect levels (P0)

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (actual dose received)

Sex:

male/female

Results: F1 generation

Details on results (F1)

There were no death throughout the entire observation period. There were no visible differences in body weight, food consumption, hematology parameters, clinical chemistry parameters, organ weight, or pathological examination between the treated and control animals. No developmental toxicities were observed.

Effect levels (F1)

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

1 000 mg/kg bw/day (actual dose received)

Sex:

male/female

Overall reproductive toxicity

Reproductive effects observed:

not specified