Registration Dossier
Registration Dossier
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EC number: 202-000-8 | CAS number: 90-51-7
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 and 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 various test chemicals
- Justification for type of information:
- Weight of evidence approach based on various test chemicals
- Reason / purpose for cross-reference:
- read-across source
- 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 various test chemicals
- Principles of method if other than guideline:
- Weight of evidence approach based on various test chemicals. The study 2,3,4 are represented as 1,2,3
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence approach based on various test chemicals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 25% of the test chemical
- Day(s)/duration:
- twice weekly for 2 weeks using 24 hours
- Adequacy of induction:
- not specified
- Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- intradermal -0.1ml Freund’s complete adjuvant in water,1% w/v test chemical in arachis oil, and Freund’s + 1% w/v test chemical in arachis oil (1:1)
epicutaneous- 2 – 0.3 ml 50% w/w test chemical in arachis oil - Day(s)/duration:
- 24 hours
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- three six-hour
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- 0.2 – 0.3 ml 25 and 10% w/w test chemical in arachis oil
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: NaCl/PEG400 (50/50, v/v)
- Concentration / amount:
- 25% in 0.9% NaCl/PEG400 (50/50, v/v)
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1. 10 in the test group and 4 in the control group
2. 20 Dunkin Hartley guinea pigs in test group and 10 Dunkin Hartley guinea pigs in negative controls
3. twenty guinea pigs (ten males and ten females - Details on study design:
- The data is based on weight of evidence approach based on various test chemicals
- Challenge controls:
- The data is based on weight of evidence approach based on various test chemicals
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Group:
- test chemical
- No. with + reactions:
- 0
- Clinical observations:
- no dermal reactions observed
- 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 and 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 dermal sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.
Cumulative contact enhancement test (CCET) was performed on guinea pigs to assess the dermal sensitization potential of the test chemical. Preliminary irritation tests were carried out to determine concentrations of the test chemical suitable for induction of sensitization and for sensitization challenge. Dunkin-Hartley Guinea pigs weighing approximately 350 grams, 10 in the test group and 4 in the control group were used for the assay. 25% of the test chemical was applied twice weekly for 2 weeks using 24 hours occlusive patches to the shoulder area of test animals to induce dermal reactions. Immediately before the third application,
the test and 4 control guinea pigs were injected with Freund's complete adjuvant in the shoulder region at the site to be patched.Test and control animals were challenged after a 12 days rest period by open application at the maximum non-irritant concentration (25%). 25% in 0.9% NaCl/PEG400 (50/50, v/v) was applied to the shoulder region of the test animals and observed for erythema. Challenge sites were scored for erythema (scale 0-3) at 24 and 48 hours.
0% guinea pigs were sensitized when evaluated after the challenge exposure. the test chemical failed to induce any evidence of sensitization at higher concentrations in the cumulative contact enhancement test (CCET). Therefore, the test chemical was considered to be not sensitizing.
This is supported by the results of the OECD 406 Guideline study perfomed on Dunkin Hartley guinea pigs to observe the sensitizing efficacy of the test chemical
20 Dunkin Hartley guinea pigs in test group and 10 Dunkin Hartley guinea pigs in negative controls were used. Guinea pigs were induced with intradermal injections of 0.1ml Freund’s complete adjuvant in water,1% w/v test chemical in arachis oil, and Freund’s + 1% w/v test chemical in arachis oil (1:1) into three separate sites.After 1 week, a single topical application of 0.2 – 0.3 ml 50% w/w test chemical in arachis oil under occlusion for 48 hours was applied. On day 21 animals were challenged with 0.1-0.2 ml 25 and 10% w/w test chemical in arachis oil.
Since there was no evidence of any skin reaction, the test chemical can be concluded as not sensitizing to guinea pigs.
These results are further supported by a study performed to determine if the test chemical causes delayed hypersensitivity in guinea pigs
In a preliminary dose-range finding study, four animals (two males and two females) were exposed to one concentration (as received) of the test chemical at four skin sites. Based upon the results of the dose-range finding study, the dose chosen for induction was 100 %.
The test chemical was dermally applied to twenty guinea pigs (ten males and ten females for a total of three six-hour insult periods at a 100 % concentration. An additional group of ten guinea pigs (five males and five females) was treated with 1-chloro-2,4 -dinitrobenzene at 0.3% concentration for a total of three six-hour insult periods. Fourteen days after the last induction period, all animals were challenged at a naive site. A positive response was elicited in the animals receiving the positive control article, 1-chloro-2,4 -dinitrobenzene (DNCB). Redness and edema scores in all animals at 24 and 48 h recorded after each treatment and at 24 and 48 h after the challenge.
No positive responses were observed in guinea pig receiving the test chemical at 100 % concentration at 24 or 48 hours after the challenge exposure. The test chemical did not cause hypersensitivity in quinea piqs.
Hence, the test chemical was considered to be not sensitizing to the skin of Guinea pig.
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 and 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:
Skin Sensitization:
The dermal sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.
Cumulative contact enhancement test (CCET) was performed on guinea pigs to assess the dermal sensitization potential of the test chemical. Preliminary irritation tests were carried out to determine concentrations of the test chemical suitable for induction of sensitization and for sensitization challenge. Dunkin-Hartley Guinea pigs weighing approximately 350 grams, 10 in the test group and 4 in the control group were used for the assay. 25% of the test chemical was applied twice weekly for 2 weeks using 24 hours occlusive patches to the shoulder area of test animals to induce dermal reactions. Immediately before the third application,
the test and 4 control guinea pigs were injected with Freund's complete adjuvant in the shoulder region at the site to be patched.Test and control animals were challenged after a 12 days rest period by open application at the maximum non-irritant concentration (25%). 25% in 0.9% NaCl/PEG400 (50/50, v/v) was applied to the shoulder region of the test animals and observed for erythema. Challenge sites were scored for erythema (scale 0-3) at 24 and 48 hours.
0% guinea pigs were sensitized when evaluated after the challenge exposure. the test chemical failed to induce any evidence of sensitization at higher concentrations in the cumulative contact enhancement test (CCET). Therefore, the test chemical was considered to be not sensitizing.
This is supported by the results of the OECD 406 Guideline study perfomed on Dunkin Hartley guinea pigs to observe the sensitizing efficacy of the test chemical
20 Dunkin Hartley guinea pigs in test group and 10 Dunkin Hartley guinea pigs in negative controls were used. Guinea pigs were induced with intradermal injections of 0.1ml Freund’s complete adjuvant in water,1% w/v test chemical in arachis oil, and Freund’s + 1% w/v test chemical in arachis oil (1:1) into three separate sites.After 1 week, a single topical application of 0.2 – 0.3 ml 50% w/w test chemical in arachis oil under occlusion for 48 hours was applied. On day 21 animals were challenged with 0.1-0.2 ml 25 and 10% w/w test chemical in arachis oil.
Since there was no evidence of any skin reaction, the test chemical can be concluded as not sensitizing to guinea pigs.
These results are further supported by a study performed to determine if the test chemical causes delayed hypersensitivity in guinea pigs
In a preliminary dose-range finding study, four animals (two males and two females) were exposed to one concentration (as received) of Dapsone at four skin sites. Based upon the results of the dose-range finding study, the dose chosen for induction was 100 %.
The test chemical was dermally applied to twenty guinea pigs (ten males and ten females for a total of three six-hour insult periods at a 100 % concentration. An additional group of ten guinea pigs (five males and five females) was treated with 1-chloro-2,4-dinitrobenzene at 0.3% concentration for a total of three six-hour insult periods. Fourteen days after the last induction period, all animals were challenged at a naive site. A positive response was elicited in the animals receiving the positive control article, 1-chloro-2,4 -dinitrobenzene (DNCB). Redness and edema scores in all animals at 24 and 48 h recorded after each treatment and at 24 and 48 h after the challenge.
No positive responses were observed in guinea pig receiving the test chemical at 100 % concentration at 24 or 48 hours after the challenge exposure. The test chemical did not cause hypersensitivity in quinea piqs.
Hence, the test chemical was considered to be not sensitizing to the skin of Guinea pig.
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 and 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 adverse effect observed (not sensitising)
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 and was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
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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