Registration Dossier
Registration Dossier
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EC number: 436-230-7 | CAS number: 359406-89-6
Skin sensitisation
Administrative data
- 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: Read-across from supporting substance. Guideline and GLP study.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- study performed before 2002
Test material
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Crl:(HA)BR
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd, Manston Road, Margate, Kent, UK
- Age at study initiation: young adult
- Weight at study initiation: 300-457 g (m); 384-563 g (f)
- Fasting period before study: not applicable
- Housing: 2 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 +/- 2
- Humidity (%): 55 +/- 15
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12:12
IN-LIFE DATES: not available
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermal - 0.03% in deionised water (test substance as supplied, containing 26.1% water)
Topical induction - 30% in deionised water (test substance as supplied, containing 26.1% water)
Concentration of test material and vehicle used for each challenge:
a) 30% in deionised water (test substance as supplied, containing 26.1% water)
b) 10% in deionised water (test substance as supplied, containing 26.1% water)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermal - 0.03% in deionised water (test substance as supplied, containing 26.1% water)
Topical induction - 30% in deionised water (test substance as supplied, containing 26.1% water)
Concentration of test material and vehicle used for each challenge:
a) 30% in deionised water (test substance as supplied, containing 26.1% water)
b) 10% in deionised water (test substance as supplied, containing 26.1% water)
- No. of animals per dose:
- Number of animals in test group: 20
males
Number of animals in negative control group: 10 males - Positive control substance(s):
- yes
- Remarks:
- hexylcinnamaldehyde
Results and discussion
- Positive control results:
- undiluted hexylcinnamaldehyde elicited a moderate skin sensitisation response.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- no information
- No. with + reactions:
- 9
- Total no. in group:
- 30
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- no information
- No. with + reactions:
- 8
- Total no. in group:
- 30
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 30%
(test substance as supplied, containing 26.1% water)
Signs of irritation during induction:
No irritation was noted following intradermal injections or
the topical application.
Evidence of sensitisation of each challenge concentration:
6/20 (30%) at 30%
2/20 (10%) at 10%
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- Under the test conditions of this study, ITC 826 Concentrate was considered as a skin sensitiser.
- Executive summary:
The sensitisation potential of ITC 826 Concentrate was assessed using a method based on the maximisation test of Magnusson and Kligman (1970).
Challenge of previously-induced guinea pigs with a 30% w/v preparation of the test sample elicited a sensitisation response (30%) with an intradermal induction at 0.03%. Challenge of previously-induced guinea pigs with a 10% w/v preparation of the test sample elicited a mild sensitisation response (10%). In a positive control study, challenge of previously-induced guinea pigs with undiluted hexylcinnamaldehyde elicited a moderate skin sensitisation response, confirming the validity of the study.
Under the test conditions of this study, ITC 826 Concentrate should be classified into category 1A (H317) according to the CLP regulation (1272/2008) including ATP2 and a skin sensitizer (Xi; R43) according to the Directive 67/548/EEC criteria.
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