Registration Dossier

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:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1950
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
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): 1,3-butylene glycol

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).