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Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Remarks:
combined repeated dose and reproduction / developmental screening
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to OECD Guideline 422
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1994
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

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 oral exposure:
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
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

Observations and examinations performed and frequency:
Study design was stated to be in line with Guide line OECD 422.
Sacrifice and pathology:
Study design was stated to be in line with Guide line OECD 422.

Results and discussion

Results of examinations

Details on results:
There were no death throughout the observation period of 42 days. Body weight, food consumption, hematology parameters, clinical chemistry parameters, organ weight, or pathological examination between the treated and control animals did not show any visible differences. Transient hypolocomotion and hypopnea at the 1000mg/kg was observed in females. This effect was not considered to be systemically adverse as it is of transient nature (probably slight and short) and there were no other effect including pathology. Beyond this, any sex difference is not pausible.

Effect levels

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (actual dose received)
Sex:
male/female
Basis for effect level:
other: Transient hypolocomotion, hypopnea in female was not regarded to be adverse. Same NAEL was applaid for both sexes.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

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