Dioctyl sebacate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Data source

Reference

Reference Type:

publication

Title:

Final report of the Cosmetic Ingredient Review Expert Panel on the safety assessment of dicarboxylic acids, salts, and esters.

Author:

Fiume MM, Heldreth B, Eldreth H, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler D, Marks JG, Shank RC, Slaga TJ, Snyder PW, Andersen FA

Year:

2012

Bibliographic source:

International Journal of Toxicology, Vol 31, Issue 4_suppl, pp. 5S - 76S, 2012

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the ocular irritation potential of dibutyl adipate in mice

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Dibutyl adipate

EC Number:

203-350-4

EC Name:

Dibutyl adipate

Cas Number:

105-99-7

Molecular formula:

C14H26O4

IUPAC Name:

Dibutyl adipate

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Dibutyl adipate
- Molecular formula : C14H26O4
- Molecular weight : 258.355 g/mol
- Smiles notation : C(CCCCC(OCCCC)=O)(OCCCC)=O
- InChI: 1S/C14H26O4/c1-3-5-11-17-13(15)9-7-8-10-14(16)18-12-6-4-2/h3-12H2,1-2H3
- Substance type: Organic
- Physical State: Liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): Dibutyl adipate
- Molecular formula : C14H26O4
- Molecular weight : 258.355 g/mol
- Smiles notation : C(CCCCC(OCCCC)=O)(OCCCC)=O
- InChI: 1S/C14H26O4/c1-3-5-11-17-13(15)9-7-8-10-14(16)18-12-6-4-2/h3-12H2,1-2H3
- Substance type: Organic
- Physical State: Liquid

Test animals

Species:

mouse

Strain:

other: hairless

Details on test animals or test system and environmental conditions:

no data available

Test system

Type of coverage:

not specified

Preparation of test site:

other: hairless

Vehicle:

other: acetone

Controls:

not specified

Amount / concentration applied:

10% in acetone

Duration of treatment / exposure:

once daily for 1 day

Observation period:

10 days

Number of animals:

5 hairless mice

Details on study design:

Details on study design

- Area of exposure: ear

SCORING SYSTEM: no data

Results and discussion

In vitro

Other effects / acceptance of results:

no data available

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 10 days

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No adverse effects observed

Any other information on results incl. tables

Table: Primary Dermal Irritation Study results

Name of the test chemical	Dose	No. of animals	Procedure	Results
Dibutyl adipate	10% in acetone	5 hairless mice	Applied to ear, 1*1day, 10 days	No adverse effects observed

 

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

Application of dibutyl adipate 10% in acetone produced no adverse effects to the ears of hairless mice.
Hence, dibutyl adipate can be considered as not irritating to skin.

Executive summary:

A skin irritation study was performed to assess the irritation potential of dibutyl adipate. Dibutyl adipate 10% in acetone was applied to the ears of 5 hairless mice and effects were observed till 10 days. No adverse effects were observed after 10 days.Hence, dibutyl adipate can be considered as not irritating to skin.