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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
sub-chronic toxicity: dermal
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short summary of results available, no Guideline followed.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Amended Final Report of the Safety Assessment of Dibutyl Adipate as Used in Cosmetics
Author:
Anderson, A.
Year:
2006
Bibliographic source:
International Journal of Toxicology, 25 (Suppl. 1); 129-134, 2006
Reference Type:
study report
Title:
Unnamed
Year:
1951

Materials and methods

Principles of method if other than guideline:
4 dogs were soaked twice a week in an emulsion containing test substance for 3 months. A control group contained 2 dogs treated with vehicle emulsifier. Changes in body weight and skin changes were monitored.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dibutyl adipate
EC Number:
203-350-4
EC Name:
Dibutyl adipate
Cas Number:
105-99-7
Molecular formula:
C14H26O4
IUPAC Name:
1,6-dibutyl hexanedioate
Details on test material:
- Name of test material (as cited in study report): Dibutyl Adipate
- Analytical purity: not given, an emulsion containing 6.25% dibutyl adipate and 0.625% emulsifier was used

Test animals

Species:
dog
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
open
Vehicle:
other: emulsifier 75 H 14S
Details on exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL/kg bw/day
- Concentration (if solution): 6.25% dibutyl adipate in an emulsion containing 0.625% emulsifier
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
3 months
Frequency of treatment:
twice a week
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
2 mL/kg bw/day
Basis:
nominal per unit body weight
Remarks:
Doses / Concentrations:
125 mg/kg bw/day (test material concentration in solution assuming w/v)
Basis:
other: calculated from % of solution and volume
No. of animals per sex per dose:
4 animals in treated group
2 animals in control group
Control animals:
yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:
DERMAL IRRITATION (if dermal study): Yes

BODY WEIGHT: Yes

Results and discussion

Results of examinations

Details on results:
BODY WEIGHT AND WEIGHT GAIN
No statistically significant changes in body weight were observed during the study.

OTHER FINDINGS
Slight desquamation was found on the skin of three treated dogs and one control dog, but there was no erythema.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
2 other: mL/kg bw
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: no significant changes in body weight and no erythema on skin
Dose descriptor:
NOAEL
Effect level:
125 mg/kg bw/day
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: no significant changes in body weight and no erythema on skin; recalculated value from applied emulsion (test material concentration and volume)

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion