Registration Dossier
Registration Dossier
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EC number: 817-668-1 | CAS number: 667899-24-3
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 vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 7th April 2004 to 13rd May 2014
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed in 2004, before the requirement for LLNA method was mandated as per the amendment to Annex VII.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: SLC Japan Co., Ltd (3371-8 Koto-cho, Hamamatsu-shi, Shizuoka, Japan)
- Age at study initiation: four weeks old
- Weight at study initiation: 339 g at the time of induction and 486 g at challenge
- Housing:at the time of acquisition 5 per cage in aluminum cages which were installed in an automatically washable rack.
- Diet (e.g. ad libitum): Pellet feed (RC4, Oriental Yeast Co., Ltd)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±2ºC
- Humidity (%): 50±10%
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 30%
- Route:
- intradermal
- Vehicle:
- other: FCA and physiological saline (1:1 v/v)
- Concentration / amount:
- 0%
- Route:
- intradermal
- Vehicle:
- other: FCA and physiological saline (1:1 v/v)
- Concentration / amount:
- 60%
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0%
- Route:
- other: percutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Route:
- other: percutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0%
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 50%
- No.:
- #3
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 30%
- No.:
- #4
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 10%
- No.:
- #5
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 5%
- No.:
- #6
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0%
- No. of animals per dose:
- Total 23 animals were allocated as follows: 8 animals to the preliminary study group, 10 to the sensitization group, and 5 to the control group.
- Details on study design:
- 1) Preliminary study:
Formulations for intradermal injection (%): 40, 30, 25, 10, 5, 3, 1, 0.5, 0.3, 0.1, 0.05, 0.03
Formulations for closed application (%): 100, 50, 30, 10, 5, 3
2)Formulations for intradermal induction:
a) Emulsion of FCA and physiological saline at a ration of 1:1 (v/v)
b) 30% test substance solution
c) Emulsion of 60% test substance solution and physiological saline at a ratio of 1:1 (v/v)
d) Liquid paraffin
3) Formulation for percutaneous induction: Sensitization group: 100% test substance solution
Control group: liquid paraffin
4) Formulations for challenge (%): 100, 50, 30, 10, 5, 0 - Key result
- Reading:
- 1st reading
- 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:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the substance did not show skin sensitization potential in guinea pigs.
- Executive summary:
A study was conducted to determine the skin sensitisation potential of the substance according to a method similar to guinea pig maximisation test protocol. 23 animals were used for the study, i.e. 8 for the preliminary study, 10 for the sensitization group, and 5 for the control group. In the induction phase, animals received intradermal injections of (a) emulsion of Freund's Complete Adjuvant (FCA) and physiological saline at a ratio of 1:1, (b) 30% test substance solution (vehicle: liquid paraffin), and (c) emulsion of 60% test substance solution (vehicle: FCA) and physiological saline at a ratio of 1:1. On Day 8 of induction, undiluted test substance was applied under occlusive conditions into each of the treated sites for 48 h. Liquid paraffin was used in the control group in the same manner. The challenge was performed on Day 21 after induction by closed application for 24 h with the test substance at concentrations of 0, 5, 10, 30, 50 and 100%. The skin reactions were observed at 24 and 48 h after application and scores were evaluated. No skin reactions were observed at any of the time points at any concentration. Under the study conditions, the substance did not show skin sensitisation potential in guinea pigs (Hashiyada, 2004).
Reference
Sensitization group challenged on Day 21: Summary Table (24 hr closed application, 10 animals)
| Formulation | Concentration (%) | Observation time after removal (hr) | Score of erythema | Score of edema | Mean reaction strength |
| 0 1 2 3 4 | 0 1 2 3 4 | ||||
| 1 | 100 | 3 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
| 1 | 100 | 24 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
| 1 | 100 | 48 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
| 2 | 50 | 3 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
| 2 | 50 | 24 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
| 2 | 50 | 48 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
| 3 | 30 | 3 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
| 3 | 30 | 24 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
| 3 | 30 | 48 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
| 4 | 10 | 3 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
| 4 | 10 | 24 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
| 4 | 10 | 48 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
| 5 | 5 | 3 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
| 5 | 5 | 24 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
| 5 | 5 | 48 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
| 6 | 100 | 3 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
| 6 | 100 | 24 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
| 6 (LP) | 100 | 48 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
Mean reaction strenght=Scores of erythema and eshar formation +Score of edema/Total number of animals (Vehicle: liquid paraffin (LP))
Control group challenged on Day 21: Summary Table (24 hr closed application, 5 animals)
| Formulation | Concentration (%) | Observation time after removal (hr) | Score of erythema | Score of edema | Mean reaction strength |
| 0 1 2 3 4 | 0 1 2 3 4 | ||||
| 1 | 100 | 3 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
| 1 | 100 | 24 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
| 1 | 100 | 48 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
| 2 | 50 | 3 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
| 2 | 50 | 24 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
| 2 | 50 | 48 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
| 3 | 30 | 3 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
| 3 | 30 | 24 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
| 3 | 30 | 48 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
| 4 | 10 | 3 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
| 4 | 10 | 24 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
| 4 | 10 | 48 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
| 5 | 5 | 3 | 5 0 0 0 0 | 10 0 0 0 0 | 0 |
| 5 | 5 | 24 | 5 0 0 0 0 | 10 0 0 0 0 | 0 |
| 5 | 5 | 48 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
| 6 | 100 | 3 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
| 6 | 100 | 24 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
| 6 (LP) | 100 | 48 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
Mean reaction strenght=Scores of erythema and eshar formation +Score of edema/Total number of animals (Vehicle: liquid paraffin (LP))
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
A study was conducted to determine the skin sensitisation potential of the substance according to a method similar to guinea pig maximisation test protocol. 23 animals were used for the study, i.e. 8 for the preliminary study, 10 for the sensitization group, and 5 for the control group. In the induction phase, animals received intradermal injections of (a) emulsion of Freund's Complete Adjuvant (FCA) and physiological saline at a ratio of 1:1, (b) 30% test substance solution (vehicle: liquid paraffin), and (c) emulsion of 60% test substance solution (vehicle: FCA) and physiological saline at a ratio of 1:1. On Day 8 of induction, undiluted test substance was applied under occlusive conditions into each of the treated sites for 48 h. Liquid paraffin was used in the control group in the same manner. The challenge was performed on Day 21 after induction by closed application for 24 h with the test substance at concentrations of 0, 5, 10, 30, 50 and 100%. The skin reactions were observed at 24 and 48 h after application and scores were evaluated. No skin reactions were observed at any of the time points at any concentration. Under the study conditions, the substance did not show skin sensitisation potential in guinea pigs (Hashiyada, 2004).
Justification for classification or non-classification
Based on the in vivo skin sensitisation study with the substance, no classification is warranted according to the EU CLP (EC 1272/2008) criteria.
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