Diallyl isophthalate

Endpoint summary

Description of key information

DAP, a closely related structural analogue, has been found to be a sensitiser and this result has been used to read-across to DAIP

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

17 December 2002 to 06 January 2003

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

ANALOGUE APPROACH JUSTIFICATION
Please refer to attached document.

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Commercial laboratory animal supplier
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 15 to 23g
- Housing: individually housed in suspended solid-floor polypropylene cages furnished with softwood flakes.
- Diet: Free access to Certified Rat and Mouse Diet supplied by International Product Supplies Ltd., Wellingborough, UK.
- Water: tap water ad libitum.
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25°C
- Humidity: 30 to 70%
- Air changes (per hr): 15
- Photoperiod: 12 hr light and 12 hours dark

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

0.5, 5,and 50 %w/v

No. of animals per dose:

4

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: no data
- Irritation: none
- Lymph node proliferation response: none

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response: radioactive disintergrations per minute per lymph node as a ratio of the 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).

TREATMENT PREPARATION AND ADMINISTRATION:
Groups of four mice were treated with the test material at concentrations of 0.5%, 5% or 50% w/v in acetone/olive oil 4:1. The mice were treated by daily application of 25µl of the appropriate concentration of the test material to the dosrsal surface of each ear for three consecutive days Days 0, 1, and 2). The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette. A further group of four mice received the vehicle alone in the same manner.

Five days following the first topical application of the test material (day 5) all mice were injected via the tail vein with 250 µl of phophate buffered saline containing 3H-methyl thymidine (3HTdR: 80 µCi/ml, specific activity 2.0 Ci/mmol) giving a total of 20 µCi to each mouse.

Positive control substance(s):

other: none

Key result

Parameter:

SI

Value:

0.98

Test group / Remarks:

0.5%

Key result

Parameter:

SI

Value:

3.23

Test group / Remarks:

5%

Key result

Parameter:

SI

Value:

10.74

Test group / Remarks:

50%

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material was classified as a sensitiser.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

DAP has been found to be a skin sensitiser and this result has been used to read-across to DAIP. Therefore DAIP will be classified as a skin sensitiser substance.