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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: No GLP study. NO OECD and EU guidelines were followed.
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Principles of method if other than guideline:
Method: according to Magnusson B. und Kligman A.M.: J. Invest. Derm. 52, 268-276
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Test material information:
Composition 1
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Hall Limited, Darley Oaks, Newchurch, Burton upon Trent, Staffordshire
- Weight at study initiation: 300 - 450 g
- Housing: Animals were housed in groups of five in suspended metal cages.
- Diet: ad libitum, Guinea Pig Diet, J . Waring (Feeds) Limited, Shardlow, Derbyshire
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 + 3°C
- Photoperiod (hrs dark / hrs light): 14 hours light, 10 hours dark

Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
- Intradermal induction: 1% in water
- Topical induction: 10% in water
- Topical challenge: 2% in water
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
- Intradermal induction: 1% in water
- Topical induction: 10% in water
- Topical challenge: 2% in water
No. of animals per dose:
10 (4 animals control group)
Details on study design:
RANGE FINDING TESTS:
a) intradermal injection: An area measuring 4 x 6 cm in the shoulder region of 2 guinea pigs was clipped free of hair using oster A5 electric animal clippers. Into these areas were injected simultaneously six 0 .1 mL intradermal injections as follows : 5% (animal 1) and 1% (animal 2). Animals were observed 24, 48 and 72 hours and 7 days following treatment and any evidence of localized necrosis or systemic toxicity was recorded. Using information obtained from this preliminary test the concentration of test material to be used for the Main Study was selected .
b) The test material at four concentrations (usually 100%, 50%, 25% and 10%) was topically applied under an occlusive patch to four sites on the shaved backs of each of a group of two guinea pigs. The degree of irritancy at the test sites were evaluated for erythema immediately after removal of the patches and then at 24 and 48 hours . The concentrations of the test material to be used on two further animals were chosen, applied and then evaluated after similar time intervats. Using the information obtained from this preliminary test the concentrations to be used for topical challenge in the Main Study were selected.

MAIN STUDY
A. INDUCTION EXPOSURE (indradermal)
- No. of exposures: 1
- Exposure period: single exposure
- Test groups: The treated animals were injected on three different sites of the shaved flank with either of three solutions (Freuds complete adjuvance (FCA) alone, test material alone, test material with FCA).
- Control group:The control animals were received similar treatment to the test group (FCA alone, sodium chloride alone, sodium chloride with FCA)
- Site: shoulder region
- Frequency of applications: single


If the test material was found to be non-irritating in the siting test, the area was pretreated with 10% sodium lauryl sulphate (SLS) in petrolatum 24 hours prior to topical application.

INDUCTION EXPOSURE (topical application)
- No. of exposures: 1
- Exposure period: at day 7
- Test groups: The treated animals were induced with the test substance.
- Control group:The control animals were treated with sodium chloride.
- Site: shoulder region
- Frequency of applications: single


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after the topical induction
- Exposure period: 24, 48 h
- Test groups: The animals were treated with the test material.
- Control group: The control animals were treated with the vehicle (only).
- Site: shoulder region
- Concentrations: 2 %
- Evaluation (hr after challenge):24 and 48 hours

Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2 %
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 2 %. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
2 %
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2 %. No with. + reactions: 4.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
2 %
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2 %. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
2 %
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2 %. No with. + reactions: 2.0. Total no. in groups: 10.0.

As indicated in the above table 4/10 of the animals in the test group showed evidence of erythema at the challenge sites. As no evidence of erythema was observed in any of the control animals, these effects seen in the test group were attributed to contact sensitization.

The test material, therefore, produced a 40% sensitization rate and was classified as a moderate (GRADE III) contact sensitizer.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In the key study, the test item was assessed for its skin sensitising potential using the maximization test in guinea pigs. Following test concentrations of the test material were prepared: for intradermal induction: 1% in water, for topical induction: 10% in water, for topical challenge: 2% in water. 4/10 of the animals in the test group showed evidence of erythema at the challenge sites. As no evidence of erythema was observed in any of the control animals, these effects seen in the test group were attributed to contact sensitization. The test material, therefore, produced a 40% sensitization rate and was classified as a moderate (GRADE III) contact sensitizer.


Migrated from Short description of key information:
The sensitisation potential of the test item was tested in an in vivo study (Maximization test). The test item was found to be moderate (Grade III) contact sensitizer.

Justification for selection of skin sensitisation endpoint:
Only one key study is available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results, the substance should be classified and labelled as Skin Sens. cat 1 (H317: May cause an allergic skin reaction.) according to Regulation (EC) No 1272/2008 and as R43 May cause sensitisation by skin contact acccording to Directive 67/548/EEC.