Bis(1-methylheptyl) adipate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Remarks:

Predates acceptance of Commission Regulation(EU) 2016/1688

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Justification for type of information:

Evaluated as a valid study by the Expert Panel of the U.S. Cosmetic Ingredient Review. There is no information regarding adherance to an OECD guideline and GLP, which it likely predates (1984).

Data source

Reference

Reference Type:

publication

Title:

Final Report on the Safety Assessment of Dioctyl Adipate and Diisopropyl Adipate

Author:

Elder, RL (ed.), et al.

Year:

1984

Bibliographic source:

Am. J. Coll. Toxicol. 3(3): 101-129.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

Similar to Magnusson Kligman Maximisation Test, but likely predates this protocol.

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Predates development of LLNA (2002) and passage of Commission Regulation(EU) 2016/1688

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-ethylhexyl) adipate

EC Number:

203-090-1

EC Name:

Bis(2-ethylhexyl) adipate

Cas Number:

103-23-1

Molecular formula:

C22H42O4

IUPAC Name:

bis(2-ethylhexyl) adipate

Test material form:

liquid

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: albino

Sex:

male

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

olive oil

Concentration / amount:

0.1%

Day(s)/duration:

3 days weekly

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

intradermal

Vehicle:

olive oil

Concentration / amount:

0.05%

Day(s)/duration:

14 days

Adequacy of challenge:

not specified

No. of animals per dose:

10

Details on study design:

Male guinea pigs were prepared for the test as follows: an area on the backs and flanks were clipped free from hair. The dose was injected intracutaneously with 0.1% of the test material in olive oil. Injections were made every other day, three times weekly, until 10 had been given. The first was 0.05 ml and all subsequent ones were 0.1 ml each. Two weeks after the last injection, a challenge dose of 0.05 ml was injected. Observations were made 24 h after each injection as to the area, height, and color of the reaction. The retest or challenge injection reaction was compared with an average of the scores taken after the original 10 doses.

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

No postive skin reactions

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

The Expert Panel of the U.S. Cosmetic Ingredient Review evaluated this study along with others in light of data on the large category of Dicarboxylic Esters (2012), and determined that this substance was not a sensitiser.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a Maximisation test, bis(diethylhexyl) adipate at a concentration of 0.1% was determined not to be sensitising to guinea pigs. The substance is not sensitising according to the criteria of Regulation EC No. 1272/2008 and is not classified for EU GHS.