Registration Dossier
Registration Dossier
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Reaction mass of hexasodium 2-[{8-amino-7-[(5-{[4-chloro-6-(4-{[2-(sulfonatooxy)ethyl]sulfonyl}anilino)-1,3,5-triazin-2-yl]amino}-2-sulfonatophenyl)diazenyl]-1-yhdroxy-3,6-disulfonato-2-naphthyl}diazenyl]naphthalene-1,5-disulfonate and pentasodiu2-[(8-amino-7-{[5-({4-chloro-6-[4-(vinylsulfonyl)anilino]-1,3,5-triazin-2-yl}amino) -2-sulfonatophenyl]diazenyl}-1-hydroxy-3,6-disulfonato-2-naphthyl)diazenyl]naphthalene-1,5-disulfonate
EC number: 617-054-1 | CAS number: 80315-17-9
Endpoint summary
Administrative data
Description of key information
.
By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".
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:
- wwight 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
- 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
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence approach based on various test chemicals
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
- Species:
- other: 1. guinea pigs; 2. humans; 3. guinea pigs
- Strain:
- not specified
- Sex:
- male/female
- Route:
- intradermal
- Vehicle:
- other: 1% CMC and in an emulsion of FCA/physiological saline
- Concentration / amount:
- 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 1% CMC and in an emulsion of FCA/physiological saline
- Concentration / amount:
- 25% in 1% CMC
- Day(s)/duration:
- 18 hours for 1 week
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5% in 119 patients and 10% in 193 patients.
- Day(s)/duration:
- 3 days
- Adequacy of induction:
- not specified
- Route:
- other: no data available
- Vehicle:
- not specified
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 1% CMC and in an emulsion of FCA/physiological saline
- Concentration / amount:
- 25% dilution in 1% CMC and in an emulsion of FCA/physiological saline
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5% in 119 patients and 10% in 193 patients.
- Day(s)/duration:
- 3 days
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- other: no data available
- Vehicle:
- not specified
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1. 15 -10 test and 5 control
2. 312
3. no data available - 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 reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".
- Executive summary:
The skin sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.
A Maximization test was performed on guinea pigs to assess the dermal sensitization potential of the test chemical
The intradermal induction of sensitisation in the test group was performed in the nuchal region with a 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitisation was conducted for 18 hours under occlusion with the test item at 25% in 1% CMC one week after the intradermal induction and following pre-treatment of the test areas with 10% sodium-laureth-sulfate (SLS), 24 hours prior to application of the test item. The animals of the control group were intradermally induced with 1% CMC and FCA/physiological saline and epidermally induced with 1% CMC under occlusion following pre-treatment with 10% SLS. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. No skin sensitization reaction was observed. Hence the test chemical was considered to be not skin sensitizing in guinea pig.
This is supported by the results of a patch test performed on 312 consecutive patients to determine the allergic potential of the test chemical.
312 consecutive patients underwent patch tests with reactive dyes to determine the allergic contact dermatitis potential.
The dyes tested were provided as powder by Hoechst and were dispersed in petrolatum. The dyes were applied to the healthy sin of the back with Finn Chambers, on Scanpor tape for 3 days and read at 3 hours after removal and at 4 days according to ICDRG Scoring pattern. The concentration used was 5% in 119 patients and 10% in 193 patients.
No positive allergic or irritant reactions were observed in the volunteers when tested with 5% and 10% concentration of the dye.
Hence, the test chemical can be considered to not sensitizing to human skin.
The above results are further supported by a skin sensitization test was carried out in guinea pigs to determine the allergic potential of the test chemical. Since the guinea pigs did not elicit any sensitizing effect, the test chemical was considered to be not sensitizing to the guinea pigs.
By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".
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.
A Maximization test was performed on guinea pigs to assess the dermal sensitization potential of the test chemical
The intradermal induction of sensitisation in the test group was performed in the nuchal region with a 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitisation was conducted for 18 hours under occlusion with the test item at 25% in 1% CMC one week after the intradermal induction and following pre-treatment of the test areas with 10% sodium-laureth-sulfate (SLS), 24 hours prior to application of the test item. The animals of the control group were intradermally induced with 1% CMC and FCA/physiological saline and epidermally induced with 1% CMC under occlusion following pre-treatment with 10% SLS. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. No skin sensitization reaction was observed. Hence the test chemical was considered to be not skin sensitizing in guinea pig.
This is supported by the results of a patch test performed on 312 consecutive patients to determine the allergic potential of the test chemical.
312 consecutive patients underwent patch tests with reactive dyes to determine the allergic contact dermatitis potential.
The dyes tested were provided as powder by Hoechst and were dispersed in petrolatum. The dyes were applied to the healthy sin of the back with Finn Chambers, on Scanpor tape for 3 days and read at 3 hours after removal and at 4 days according to ICDRG Scoring pattern. The concentration used was 5% in 119 patients and 10% in 193 patients.
No positive allergic or irritant reactions were observed in the volunteers when tested with 5% and 10% concentration of the dye.
Hence, the test chemical can be considered to not sensitizing to human skin.
The above results are further supported by a skin sensitization test was carried out in guinea pigs to determine the allergic potential of the test chemical. Since the guinea pigs did not elicit any sensitizing effect, the test chemical was considered to be not sensitizing to the guinea pigs.
By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The results of the experimental studies from the various test chemicals indicate a possibility that the test chemical can be not sensitizing to skin.
Hence, by applying the weight of evidence approach,the test chemicalcan be considered to be not sensitizing to skin.
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