Reaction products of imine and acrylate

Skin sensitisation

Administrative data

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.

Data source

Reference

Reference Type:

publication

Title:

Étude expérimentale du pouvoir sensibilisant d´un échantillonnage de polyaziridines

Author:

Zissu D

Year:

2003

Bibliographic source:

Cahiers de Notes Documentaires - Hygiène et sécurité du travail, No. 193, 19-21.

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Pentaerythritol tris(3-aziridin-1-ylpropionate)

EC Number:

260-568-2

EC Name:

Pentaerythritol tris(3-aziridin-1-ylpropionate)

Cas Number:

57116-45-7

Molecular formula:

C20H33N3O7

IUPAC Name:

3-{[3-(1-Aziridinyl)propanoyl]oxy}-2-({[3-(1-aziridinyl)propanoyl]oxy}methyl)-2-(hydroxymethyl)propyl 3-(1-aziridinyl)propanoate

Details on test material:

Purity: > 99%

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

water

Induction 2

Concentration / amount:

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

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

water

Challenge 2

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)

Results and discussion

Positive control results:

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

In vivo (non-LLNA)

Results

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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.