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Description of key information

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