Registration Dossier
Registration Dossier
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EC number: 425-450-9 | CAS number: 294-90-6
Endpoint summary
Administrative data
Description of key information
Skin sensitisation. Key study (001). Test method according to 92/69/EWG, B.6 and OECD 406 Guidelines. GLP study.
Skin sensitisation. Key study (002). Test method according to 92/69/EWG, B.6. GLP study.
Data waiving (study scientifically not necessary / other information available): data from an in vivo study
was available. Therefore, an in vitro study was not deemed necessary.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, B.6
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Migrated from NONS file.
- Species:
- guinea pig
- Strain:
- Himalayan
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 20% test substance in 1% aqueous carboxylmethyl cellulose
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 5% test substance in 1% aqueous carboxylmethyl cellulose
- No. of animals per dose:
- Number of animals in test group: 10Number of animals in negative control group: 5
- Challenge controls:
- Negative challengue controls
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Erythema (24 h) and necrosis (24 and 48 h)after injection.
- Erythema in 2 treated animals (day 10).
- Interpretation of results:
- other: Not classified
- Remarks:
- Migrated information criteria used for interpretation of results: EU
- Conclusions:
- The test substance was not classified as a sensitisation agent.
- Executive summary:
A skin sensitization test was performed according to OECD guideline 406 and 92/69/EWG, B.6 Guideline under GLP conditions.
Himalayan guinea pigs were administered with test substance using CMC as a vehicle (20% test substance in 1% aqueous CMC for test subjects and 5% test substance in 1% aqueous CMC for the challenge group). Readings were performed 24 and 48h after injection.
The results provided evidence that the test substance did not cause any irritating effects hence, the test substance is not classified as a skin sensitizer agent.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, B.6 (Meerschewinchen-Maximierungstest (GPMT))
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Migrated from NONS file.
- Species:
- guinea pig
- Strain:
- Himalayan
- Route:
- intradermal
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 0.2% test substance in 1% aqueous carboxylmethyl cellulose
- Route:
- other: Epidermal
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 20% test substance in 1% aqueous CMC
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 5% test substance in 1% aqueous carboxylmethyl cellulose
- No. of animals per dose:
- Number of animals in test group: 10Number of animals in negative control group: 5
- Challenge controls:
- Negative challengue controls
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Intradermal: 10/10 (Erythema 1/10, value 2); necrosis 9/10, diameter 2mm (7) or 3 (2) mm
- Epidermal: 2/10 (Erythema, value 2)
- Interpretation of results:
- other: Not classified
- Remarks:
- Migrated information criteria used for interpretation of results: EU
- Conclusions:
- The test substance was classified as a not sensitizing agent.
- Executive summary:
A skin sensitization test was performed according to 92/69/EWG, B.6 Guideline under GLP conditions.
Himalayan guinea pigs were administered intradermally and epidermally with test substance, using CMC as a vehicle (0.2% test substance in 1% aqueous CMC for intradermal and 20% test substance in 1% aqueous CMC for epidermal). Readings were performed at 24 and 48h after injection.
The results provided evidence that the test substance can be classified as a non-sensitizer agent.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- Justification for type of information:
- A skin sensitisation in vivo was already available.
Referenceopen allclose all
Maximum concentration not causing irritating effects in preliminary test: 20 %.
Signs of irritation during induction:
Evidence of sensitisation of each challenge concentration:
No evidence of sensitization.
Other observations:
None
Maximum concentration not causing irritating effects in preliminary test: 5 %.
Signs of irritation during induction:
Evidence of sensitisation of each challengue concentration: 0/10
Evidence of sensitisation of each challenge concentration:
No evidence of sensitization.
Other observations:
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitization. Key study (001). Test method according to 92/69/EWG, B.6 and OECD 406 Guidelines. GLP study. Himalayan guinea pigs were administered with test substance using CMC as a vehicle (20% test substance in 1% aqueous CMC for test subjects and 5% test substance in 1% aqueous CMC for the challenge group). Readings were performed 24 and 48h after injection. The results provided evidence that the test substance did not cause any irritating effects hence, the test substance is not classified as a skin sensitizer agent.
Skin sensitization. Key study (002). Test method according to 92/69/EWG, B.6., comparable to guideline but with acceptable restrictions. GLP study. Himalayan guinea pigs were administered intradermally and epidermally with test substance, using CMC as a vehicle (0.2% test substance in 1% aqueous CMC for intradermal and 20% test substance in 1% aqueous CMC for epidermal). Readings were performed 24 and 48h after injection. The results provided evidence that the test substance can be classified as a non-sensitizer agent.
Justification for selection of skin sensitisation endpoint:
No selection was done, both studies were negative.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on all the available information, test substance is not classified for skin sensitization.
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