Reaction products of imine and acrylate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Equivalent to EU method B.6. No data on GLP.

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Deviations:

no

Principles of method if other than guideline:

Magnusson and Kligman maximisation test

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River
- Weight at study initiation: 350 g
- Housing: The animals were housed individually in polypropylene cages
- Diet (e.g. ad libitum): Sterilized granules (UAR 114); ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 ± 1 ºC
- Humidity (%): 50 ± 5%
- Air changes (per hr): 15 cycles/hour
- Photoperiod (hrs dark / hrs light): light - dark cycle 12 h:12 h

Route:

intradermal and epicutaneous

Vehicle:

water

Concentration / amount:

Induction: 0.5 and 0.1 % p/v (in water)
Challenge: 0.5 % p/v (in water)

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

Induction: 0.5 and 0.1 % p/v (in water)
Challenge: 0.5 % p/v (in water)

No. of animals per dose:

Treatment: 20 animals
Control: 10 animals

Details on study design:

RANGE FINDING TESTS:
The concentrations used in the main study were established in a preliminary study to determine the lowest concentrations producing low irritation for the induction phase and the highest non irritant concentrations for the challenge phase.

MAIN STUDY
A. INDUCTION EXPOSURE
Day 1:
Three pairs of intradermal injections of 0.1 ml are given in the shoulder region.
Injection 1: the test substance in an appropriate vehicle at the selected concentration
Injection 2: a 1:1 mixture (v/v) FCA/physiological saline
Injection 3: the test substance at the selected concentration formulated in a 1:1 mixture (v/v) FCA/physiological saline.

Day 8: The substance is applied to the treated area (occlusive) at a slightly irritant concentration for 48 hours.

The control group is treated with the vehicle and FCA following the same conditions as for the treated group.

B. CHALLENGE EXPOSURE
- Day(s) of challenge: Day 22
- Exposure period: 24 h
- Concentrations: 0.5 ml of the test substance at the highest non irritant concentration (occlusive)
- Evaluation (hr after challenge): 24 and 48 h

Positive control substance(s):

yes

Remarks:

(α-hexylcinnamaldehyde (HCA), CAS No. 101-86-0)

Positive control results:

The percentage of animals showing a positive response was 31% (6/19).

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

No. with + reactions:

6

Total no. in group:

13

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 6.0. Total no. in groups: 13.0.

During the induction phase, seven animals were found death 30 minutes after the treatment using intradermal injections.

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The percentage of animals showing a positive response after treatment with the test substance was 50% (6/13). The substance is considered to be a skin sensitiser.

Executive summary:

A Magnusson and Kligman maximisation test was performed to determine the sensitising potential of the test substance. The percentage of animals showing a positive response after treatment with the test substance was 50% (6/13). The substance is considered to be a skin sensitiser.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Key study: Equivalent to EU method B.6. No data on GLP.

A Magnusson and Kligman maximisation test was performed to determine the sensitising potential of the test substance. The percentage of animals showing a positive response after treatment with the test substance was 50% (6/13). The substance is considered to be a skin sensitiser.

Migrated from Short description of key information:
Key study: Equivalent to EU method B.6. No data on GLP.
A Magnusson and Kligman maximisation test was performed to determine the sensitising potential of the test substance. The percentage of animals showing a positive response after treatment with the test substance was 50% (6/13). The substance is considered to be a skin sensitiser.

Justification for selection of skin sensitisation endpoint:
Klimisch 2. Equivalent to EU method B.6. No data on GLP.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available data, the substance is classified as Skin sensitiser Category 1B.

Guinea pig maximisation test:

≥ 30 % to < 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose