Registration Dossier
Registration Dossier
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EC number: 203-529-7 | CAS number: 107-88-0
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 1950
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: insufficient documentation
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 950
- Report date:
- 1950
Materials and methods
- Principles of method if other than guideline:
- dermal toxicity after repeated application
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Limit test:
- no
Test material
- Reference substance name:
- Butane-1,3-diol
- EC Number:
- 203-529-7
- EC Name:
- Butane-1,3-diol
- Cas Number:
- 107-88-0
- Molecular formula:
- C4H10O2
- IUPAC Name:
- butane-1,3-diol
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): 1,3-butylene glycol
Constituent 1
Test animals
- Species:
- guinea pig
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- - substance was applied to the shaved, intact abdominal skin (14 day exposure) or to the shaved and scraped abdominal skin (4 day exposure)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 2 hrs per day for 4 or 14 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
20 ml/kg bw
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- - no data
- Control animals:
- not specified
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 20 100 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: calculated assuming a density of 1.0053 g/ml (according to CTFA, 1985).
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
- no adverse effects were observed
- no histological changes have been observed in liver, kidney or bladder
- no protein or blood pigment was detected in the urine
Applicant's summary and conclusion
- Executive summary:
Application of 20100 mg/kg bw/d of 1,3-butylene glycol for 2 hrs/day to the intact or scarped skin of guinea pig for 14 or 4 days respectively did not result in any adverse effect (Kopf et al., 1950).
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