Registration Dossier
Registration Dossier
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EC number: 200-769-4 | CAS number: 71-91-0
Endpoint summary
Administrative data
Description of key information
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Weight of evidence approach based on test chemicals
- Justification for type of information:
- Weight of evidence approach based on test chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: Weight of evidence approach based on test chemicals
- Principles of method if other than guideline:
- Weight of evidence approach based on test chemicals
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence approach based on test chemicals
- Justification for non-LLNA method:
- No data available
- Species:
- guinea pig
- Strain:
- other: 1.Pirbright albino 2.albino
- Sex:
- male/female
- Details on test animals and environmental conditions:
- No data available
- Route:
- other: 1.epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 4%
- Day(s)/duration:
- 6h hours
- Adequacy of induction:
- not specified
- Route:
- other: 1.intradermal
- Vehicle:
- other: 0.75% saline in deionised water
- Concentration / amount:
- 0.1%
- Day(s)/duration:
- not specified
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- other: epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 1%
- Day(s)/duration:
- 6 hours
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- other: intradermal
- Vehicle:
- other: 0.75% saline in deionised water
- Concentration / amount:
- 0.1%
- Day(s)/duration:
- not specified
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1.Total :
46 Preliminary study: 6 animals
2.20 Main study- Treated group:30
Control group:102. - Positive control substance(s):
- not specified
- Reading:
- other: 1. 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 30
- Clinical observations:
- No skin sensitization reaction was observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: 2. 1st reading
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Clinical observations:
- No skin sensitization reaction was observed (8 animals died due to not particularly healthy.)
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: Not Sensitizing
- Conclusions:
- Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
- Executive summary:
The skin sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.
Buehler test was performed using 30 female Pirbright albino guinea pigs in treated group and 10 in control group to assess the dermal sensitization potential of the test chemical. Doses were selected on the bases of preliminary study using 6 animals.In induction phase, induction given on day 1, using 4 % concentration inwaterby topical application as2 x 2 cm cellulose patch to the clipped skin of the left flank. The patch was covered with an occlusive dressing for 6 hours and removed afterwards. The second induction given on day 8 and third on day 15 using same procedure on day first. During the induction phase, the skin sites wereexamined for local effects 24 hours after each treatment. In challenge phase, on day 29 test substance 1% concentration in same vehicle appliedon a 2 x 2 cm patch to the clipped skin of the right flank and covered with an occlusive dressing for 6 hour and evaluated 24 and 48hr after removal of occlusive dressing .All animals were observed daily for signs of systemic toxicity. Body weights were recorded on days 1 and 31.No skin sensitizing reaction observed after challenge applicationalso no clinical effects were observed. Body weight development of the treated group was not different from that of the control group. During the induction phase, treated animals showed slight to well-defined erythema and very slight oedema at the treated skin area. After challenge, skin reactions were observed neither in the treated group nor in the control group.Hence the test chemicalwas considered to be not skin sensitizing in guinea pig.
The above result was further supported by the another sensitization study using Intracutaneous method in 20male albino guinea pigs. During induction phase, the animals were treated intradermally at concentration of 0.1 % in 0.75% saline in deionised water by using 8 applications. After 3 weeks, the animals were challenged at the same concentration used in induction phase. No skin sensitizing reactions were observed after challenge application while 8 animals died as they were not particularly healthy. Since the death observed were not substance related, the test chemical was considered to be not sensitizing to the skin.
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.
Buehler test was performed using 30 female Pirbright albino guinea pigs in treated group and 10 in control group to assess the dermal sensitization potential of the test chemical. Doses were selected on the bases of preliminary study using 6 animals. In induction phase, induction given on day 1, using 4 % concentration in water by topical application as2 x 2 cm cellulose patch to the clipped skin of the left flank. The patch was covered with an occlusive dressing for 6 hours and removed afterwards. The second induction was given on day 8 and third on day 15 using same procedure on day first. During the induction phase, the skin sites were examined for local effects 24 hours after each treatment. In challenge phase, on day 29 test substance 1% concentration in same vehicle appliedon a 2 x 2 cm patch to the clipped skin of the right flank and covered with an occlusive dressing for 6 hour and evaluated 24 and 48hr after removal of occlusive dressing .All animals were observed daily for signs of systemic toxicity. Body weights were recorded on days 1 and 31.No skin sensitizing reaction observed after challenge applicationalso no clinical effects were observed. Body weight development of the treated group was not different from that of the control group. During the induction phase, treated animals showed slight to well-defined erythema and very slight oedema at the treated skin area. After challenge, skin reactions were observed neither in the treated group nor in the control group.Hence the test chemical was considered to be not skin sensitizing in guinea pig.
The above result was further supported by the another sensitization study using Intracutaneous method in 20male albino guinea pigs. During induction phase, the animals were treated intradermally at concentration of 0.1 % in 0.75% saline in deionised water by using 8 applications. After 3 weeks, the animals were challenged at the same concentration used in induction phase. No skin sensitizing reactions were observed after challenge application while 8 animals died as they were not particularly healthy. Since the death observed were not substance related, the test chemical was considered to be not sensitizing to the skin.
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
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