Diisononyl 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:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1967

Report date:

1967

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Draize test
Guinea pigs are challenged with 10 injecitons given intracutaneously. The the test material is applied every other day or three times a week at a random area of the back clipped free of hair.
After 14 days of the last application, a challenge injection is given. Readings of the area, height, and color (redness) of the reaction is made after 24h of the injections.
Interpretation of the sensitizing potential is dependent on the observed effects of all animals.

GLP compliance:

not specified

Type of study:

intracutaneous test

Justification for non-LLNA method:

The study was perfomed before 24 April 2002, the year the OECD guideline 429 was adopted.
Therefore, the local lymph node assay was not mandatory and has not been performed.

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:

not specified

Sex:

male

Details on test animals and environmental conditions:

no data

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

olive oil

Concentration / amount:

0.1% / 0.05 mL first injection
0.1% / 0.1 mL (9 following injecitons)

Day(s)/duration:

10

Challenge

No.:

#1

Route:

intradermal

Vehicle:

olive oil

Concentration / amount:

0.1% / 0.05 mL after 14 days

Day(s)/duration:

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.
Furthermore, 0.1 ml of a 0.1% DEHA solution was dosed three times a week for a period of 3 weeks.
Olive oil was used as a carrier.
The intracutaneous challenge treatment after 14 days with 0.05 ml of the 0.1% DEHA solution did not indicate any sensitizing potential from DEHA

Challenge controls:

no data

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1%

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

Ten male guinea pigs were treated with intracutaneous injections into the dorsal skin. On the first day, 0.05 ml of a solution containing 0.1% DEHA in olive oil. For the next 3 weeks there were injected 3 times a week with 0.1 ml of the same solution. After 14 days the intradermal challenge with 0.05 ml of the 0.1 % DEHA containing solution gave no indication for skin sensitizing properties.

The area and height of the reaction was measured 24 hours after the challenge dose. The average area and height of the reaction at challenge were smaller than during induction.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met