Registration Dossier
Registration Dossier
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EC number: 412-260-6 | CAS number: 52658-19-2 MONO 442
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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: Data provided by ECHA on request of Cytec Surface Specialties NV/SA. SNIF last update on 1993-10-25, UUID: SNIF-a53a2718-53ed-33b4-b9a3-440eef4897f2
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EEC (Magnusson and Kligman)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted before the requirement for LLNA as a basic study to perform was mandated in 2013.
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: not stated
- Age at study initiation: not stated
- Weight at study initiation: not stated
- Housing: not stated
- Diet (e.g. ad libitum): not stated
- Water (e.g. ad libitum): not stated
- Acclimation period: not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not stated
- Humidity (%): not stated
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light):not stated - Route:
- intradermal
- Vehicle:
- other: semi-liquid paraffin
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a). Intradermal 5% in semi-liquid paraffin
b). Topical 100%
Concentration of test material and vehicle used for each challenge:
a). 100% - Route:
- epicutaneous, open
- Vehicle:
- other: semi-liquid paraffin
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a). Intradermal 5% in semi-liquid paraffin
b). Topical 100%
Concentration of test material and vehicle used for each challenge:
a). 100% - No. of animals per dose:
- Number of animals in test group: 10
Number of animals in control group: 5 - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- sensitising
- Conclusions:
- Under the study conditions, the test substance was sensitising to guinea pig skin.
- Executive summary:
A study was conducted to determine skin sensitization potential of the test substance to guinea pig according to the method described in EC Regulation 92/69/EEC. Pirbright white guinea pigs were used in the skin sensitisation study. The concentration of the test substance and vehicle tested in the induction and challenge was 5% in semi-liquid paraffin. Intradermal injections of the test substance caused well defined erythema and slight oedema at the test sites of more than 30% animals. Under the study conditions, the test substance was sensitising to guinea pig skin (Anonymous, 1993).
Referenceopen allclose all
Maximum concentration not causing irritating effect in a preliminary test was 100%.
Signs of irritation during induction: slight erythema was observed at application sites, treated with the vehicle alone, for up to 3 days and at sites treated with the test substance in vehicle, up to 5 days after application.
Evidence of sensitisation for each challenge concentration:
- 1st challenge: 4 out of 10,
- 2nd challenge: 8 out of 10
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A study was conducted to determine skin sensitization potential of the test substance to guinea pig according to the method described in EC Regulation 92/69/EEC. Pirbright white guinea pigs were used in the skin sensitisation study. The concentration of the test substance and vehicle tested in the induction and challenge was 5% in semi-liquid paraffin. Intradermal injections of the test substance caused well defined erythema and slight oedema at the test sites of more than 30% animals. Under the study conditions, the test substance was sensitising to guinea pig skin (Anonymous, 1993).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on an in vivo skin sensitisation study, the test substance warrants a classification of Skin Sens 1B (H317: May cause an allergic skin reaction) according to EU CLP (EC 1272/2008) criteria.
.Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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