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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:
supporting study
Study period:
2007-10-26 - 2008-02-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed under GLP regulations. For read across justification please refer to IUCLID chapter 13.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
An appropriate guinea pig maximisation test is available
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Dunkin Hartley, Crl:HA
- Source: Charles River Laboratories, Kisslegg - Germany
- Age at study initiation: 5 – 8 weeks
- Weight at study initiation: 377 g – 440 g
- Housing: The animals were housed in fully air-conditioned rooms (5 animals per cage)
- Cage type: Plastic cages with perforated base; floor area: 4000 cm² (Tecniplast Deutschland GmbH)
- Diet: Kliba Labordiaet (Provimi Kliba SA, Kaiseraugst, Basel, Switzerland), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 14 days before the first test-substance application.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Route:
epicutaneous, occlusive
Vehicle:
other: Doubly distilled water
Concentration / amount:
All inductions were performed with a 10% test-substance preparation in doubly distilled water and for the challenge a 5% test-substance preparation in doubly distilled water was chosen.
Route:
epicutaneous, occlusive
Vehicle:
other: Doubly distilled water
Concentration / amount:
All inductions were performed with a 10% test-substance preparation in doubly distilled water and for the challenge a 5% test-substance preparation in doubly distilled water was chosen.
No. of animals per dose:
Number of animals of the control group: 10
Number of animals of the test group: 20
Details on study design:
Pretest:
In a pretest, the irritancy profile was determined by applying 0.5 ml of various concentrations (1%, 5%, 10%, and 25%) of aqueous test substance solutions to a 2-cm² area of the shaved flanks of Guinea pigs under occlusive conditions. Test sites were visually evaluated 1 h, 24 h and 48 h after application of test solutions. In accordance with the OECD Guideline 406 a slightly irritating concentration should be used in the main test for induction whereas the maximum non-irritant concentration should be applied for challenge.

Induction:
During the induction phase of the main test, 0.5 ml of test solution were applied to an 2-cm² area of the skin of the flank of groups of 5 Guinea pigs three times at weekly intervals, on days 0, 7 and 14 on the same application site. Skin readings were performed 24 h after application. The control animals were not treated since the doubly distilled water used as formulating agent was not expected to influence the result of the study.

Challenge:
Fourteen days after the last induction treatment, each test group animal and animals from control group were challenged with 0.5 ml of 5% aqueous solution of the test substance to a 2-cm² area on the previously untreated flank. Skin reactions were read at 24 and 48 after application of the solutions.

Evaluation:
The number of animals with skin findings at 24 and/or 48 hours after the removal of the patch was taken into account for the determination of the sensitization rate. The evaluation "sensitizing" results if at least 15 per cent of the test animals exhibit skin reactions.
Positive control substance(s):
no
Remarks:
A positive control with a known sensitizer was not included in this study. However, a separate study was performed twice a year in the same laboratory.
Positive control results:
The positive controls with Alpha-Hexylcinnamaldehyde, techn. 85% showed that the test system was able to detect sensitizing compounds under the laboratory conditions chosen.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5% test-substance preparation in doubly distilled water
No. with + reactions:
12
Total no. in group:
20
Clinical observations:
4/20: Discrete or patchy erythema (grade 1); 8/20: Moderate and confluent erythema (grade 2)
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% test-substance preparation in doubly distilled water. No with. + reactions: 12.0. Total no. in groups: 20.0. Clinical observations: 4/20: Discrete or patchy erythema (grade 1); 8/20: Moderate and confluent erythema (grade 2).
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5% test-substance preparation in doubly distilled water
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
6/20: grade 1; 10/20: grade 2
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% test-substance preparation in doubly distilled water. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: 6/20: grade 1; 10/20: grade 2 .
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5% test substance preparation in doubly distilled water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5% test substance preparation in doubly distilled water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5% test substance preparation in doubly distilled water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5% test substance preparation in doubly distilled water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Skin sensitisation

The source substance was evaluated for its potential to induce skin sensitization in a test protocol conducted according to the OECD Guideline 406 (Skin Sensitization) in Dunkin-Hartley guinea pig. The Buehler test using 5 animals per sex per dose group was conducted with source substance (TS purity 98.3%) concentrations levels in doubly distilled water of 10% (v/v) for induction, and 5.0% (v/v) at challenge (the minimal irritating concentration for induction and the maximal non irritating concentration for challenge were determined in a range-finding study with concentration levels of 1.0, 5.0, 10 and 25%). The read-across test substance was applied epicutaneously (occlusive patch) on days 0, 7 and 14 (0.5 ml; the control group received the vehicle only) for induction, and on day 29 for challenge. Skin reactions were read at 24 and 48 after application of the solutions, and the number of animals with skin findings after the removal of the patch was taken into account for the determination of the sensitization rate. 60% (12/20; 0% in the negative control group) of test animals showed positive reactions 24 hours after challenge and 80% 48 hours thereafter (16/20; 0% in the negative control group). The source substance has therefore to be considered sensitising to the guniea pig skin.


Migrated from Short description of key information:
- Skin sensitisation: OECD TG 406, guinea pig, source substance: purity 98.3% (BASF AG, 2008); sensitizing
- Respiratory sensitisation: no data available

Justification for selection of skin sensitisation endpoint:
Read-across approach. Only one study available with the source substance. Estimated Klimisch Rating: 1

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available skin sensitization study for the source substance, it is concluded that the target test substance has also to be classified for skin sensitization as follows:


 


Classification, Labelling, and Packaging Regulation (EC) No 1272/2008


The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the target substance is also considered to be classified for skin sensitization under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014, as follows: Cat. 1A, H317, may cause an allergic skin reaction