Bis(2-ethylhexyl) adipate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

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

Data source

Reference

Reference 1

Reference Type:

publication

Title:

German Chemical Society Advisory Committee on Existing Chemicals of Environmental Relevance. Di-(2-ethylhexyl)adipate.

Author:

BUA

Year:

1996

Bibliographic source:

BUA Report 196. S. Hirzel Wissenschaftliche Verlagsgesellschaft, Stuttgart, 1996.

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1967

Report date:

1967

Materials and methods

Principles of method if other than guideline:

Draize test

GLP compliance:

not specified

Type of study:

intracutaneous test

Justification for non-LLNA method:

Study performed prior to implementation of the LLNA

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

Details on test material:

no data

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

male

Details on test animals and environmental conditions:

no data

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

olive oil

Induction 2

Concentration / amount:

0.1%

Challenge

Challenge 1

Route:

intradermal

Vehicle:

olive oil

Challenge 2

Concentration / amount:

0.1%

No. of animals per dose:

10

Details on study design:

DEHA was further tested for sensitisation in a Draize test with 10 male guinea pigs.
On the first day, 0.05 ml of a 0.1% DEHA solution was dosed intracutaneously in shaved back or side skin. Afterwards, 0.1 ml of a 0.1% DEHA solution was dosed every other day for a period of 3 weeks (10 injections in total). Olive oil was used as a carrier.
Two weeks after the last injection the animals were challenged intradermally with 0.05 ml of the 0.1% DEHA solution.

Challenge controls:

no data

Results and discussion

In vivo (non-LLNA)

Results

Reading:

other:

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1%

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: other:. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Observations were made 24 h after each injection as to area, height, and color of reaction. The challenge injection reaction was compared with an average of-the scores taken after the original 10 doses. The area and height of the retest area was smaller and lower than the average induction reactions. Thus no sensitizing potential could be deduced.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information