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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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