Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-350-4 | CAS number: 105-99-7
Repeated dose toxicity: dermal
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:
- 2 006
- Bibliographic source:
- International Journal of Toxicology, 25 (Suppl. 1); 129-134, 2006
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 951
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
- 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
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
