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Diss Factsheets

Administrative data

Description of key information

one Guideline study available sufficient for conclusion on the endpoint skin sensitisation.

An additional study conducted with a decomposition product of the substance is available as well.

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
Study period:
20-12-1999 - 30-03-2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study was conducted before adoption of LLNA method (OECD 429).
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 2766
- Expiration date of the lot/batch:07 December 2000
- Purity test date: not stated

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in freezer in the darik
- Stability under test conditions: not stated
- Solubility and stability of the test substance in the solvent/vehicle: solubility tested in pretest and found suitable. stability not indicated
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not stated

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Preparation of formulation within 4 hours prior each tratment. No adustment was made for specific gravity of vehicle. Homogeneity was obtained to visually acceptable levels
Species:
guinea pig
Strain:
Himalayan
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL Ltd., Füllnisdorf, Switzerland
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF
- Age at study initiation: approx. 4 weeks
- Weight at study initiation:< 500 g
- Housing: group housing of 5 animals
- Diet (e.g. ad libitum): Free access to standard guinea pig diet
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: at least 5 days
- Indication of any skin lesions: not stated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
5 %
Day(s)/duration:
Day 1
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, semiocclusive
Vehicle:
corn oil
Concentration / amount:
50%
Day(s)/duration:
Day 8: 48 h
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
corn oil
Concentration / amount:
50 %test substance concentration
Day(s)/duration:
Starting on day 22, for 24 h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS:
A preliminary irritation study was conducted in order to select test substance concentrations to be used in the main Study. The selection of concentrations was based on the following criteria:
-The concentrations are well-tolerated by the animals.
-For the induction exposures: the highest possible concentration that produced mild to
moderate irritation (grades 2・3).
-For challenge exposure: the maximum non-irritant concentration.
lntradermal iniections:
A series of four test substance concentrations was used, the highest concentration being the maximum concentration that could technically be injected. Each of two animals received two different concentrations in duplicate (0.1 ml/site) in the clipped scapular region. The injection sites were assessed for irritation 24 and 48 hours after treatment.
Epidermal application:
A series of four test substance concentrations was used, the highest concentration being the maximum concentration that could technically be applied. Two different concentrations were applied (0.5 ml each) per animal to the clipped flank, using Metalline patches# (2x3 cm) mounted on Medical tape# which were held in place with Micropore tape# and subsequently Coban elastic bandage The animals receiving intradermal injections were treated with the lowest concentrations and two further animals with the highest concentrations.
After 24 hours, the dressing was removed and the skin cleaned of residual test substance using water.
The treated skin areas were assessed for irritation 24 and 48 hours after exposure.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 48 h for epicutaneous exposure
- Test groups: 1
- Control group: 1
- Site: scapular area
- Frequency of applications: epicutaneous exposure 8 days after intradermal injections
- Duration: 21 days
- Concentrations: 5% intradermal, 50% epicutaneous

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Test groups: 1
- Control group: 1
- Site: flank
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 hours after removal of the dressing

OTHER:
Challenge controls:
vehicle only
Positive control substance(s):
yes
Remarks:
alpha-hexylcinnamic aldehyde
Positive control results:
The skin reactions in the experimental animals observed in response to the 10% ALPHA-HEXYLCINNAMICALDEHYDE, TECH. 85%
concentration in the challenge phase were considered indicative of sensitisation, taking into
account the intensity and persistence of the response in the control animals
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
7
Total no. in group:
18
Clinical observations:
none
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
7
Total no. in group:
18
Clinical observations:
none
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
10 %
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
not specified
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
10 %
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
not specified
Remarks on result:
positive indication of skin sensitisation

Two animals of the test group died before Challange phase:

On day 10, one experimental animal was found dead and macroscopic post mortem

examination revealed no abnormalities.

On day 12, one experimental animal was found dead after showing lethargy and

ventro-lateral recumbence and macroscopic examination revealed small scabs in scapular area.

On day 10 Signs of toxicity (pale eyes, cold limbs, piloerection, lethargy and/or reduced mobility of the hind legs) were observed in the experimental animals.

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Under the conditions of the study, 7 of 18 animals of the test group showed positive responses to the challange exposure.
These results indicate a sensitisation rate of 39 per cent.
Based on these results and according to the Criteria lid down in (EC) No 1278/2008, the substance is classified for Skin sensitising Cat. 1
Executive summary:

The study was carried out based on the guidelines described in: EC Commission Directive 96/54/EC, Part B.6,” Skin Sensitisation”and OECD No. 406,” Skin Sensitisation”, and based on the method described by Magnusson and Kligman,”Allergic Contact Dermatitis in the Guinea Pig -Identification of Contact Allergens".

Test substance concentrations selected for the main study were based on the results of a preliminary study and a toxicity test

In the main study, twenty experimental animals were intradermally injected with a 5% concentration and epidermally exposed to a 50% concentration. Ten control animals were similarly treated, but with vehicle alone (corn oil). Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS.

Two weeks after the epidermal application all animals were challenged with a 50% test substance concentration and the vehicle.

Skin reactions of grade 1 were observed in seven experimental animals in response to the 50% test substance concentration.

No skin reactions were evident in the control animals.

Two animals were found dead on day 10 and 12 and signs of toxicity were observed on day 10.

Since the conclusion, based on the surviving animals, was not affected it was considered that this deviation had not affected the study integrity.

The skin reactions observed in response to a 50% test substance concentration in seven (of the eighteen) experimental animals in the challenge phase were considered indicative of sensitisation, based on the absence of any response in the control animals.

Although toxicity was observed and two animals were found dead, it was considered that the test substance concentration could be tolerated by the animals and that the study outcome was not adversely affected.

These results indicate a sensitisation rate of 39 per cent.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

The presented substance is classified for skin sensitisation. The substance is not an Isocyanate and there are no structural alerts as mentioned in the flow chart (REACH technical guidance document IR/CSA: scheme of R.7a, Fig 7.3-2). Therefore, in a weight of evidence approach, the present information indicate no respiratory potential.

Justification for classification or non-classification

The available information is conclusive and sufficient for classifiaction as skin sensitising cat. 1.

The available information is conclusive but not sufficient for classification as respiratory sensitising.