Registration Dossier
Registration Dossier
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EC number: 204-976-0 | CAS number: 130-14-3
Endpoint summary
Administrative data
Description of key information
Based on the available data for the structurally similar read across chemicals and applying the weight of evidence approach, it can be concluded thatSodium naphthalene-1-sulfonatewill also behave in similar manner that of the read across chemicals.Sodium naphthalene-1-sulfonatewas estimated to be not sensitizing to skin.
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:
- other: Weight of evidence approach based on similar chemicals
- Justification for type of information:
- Weight of evidence approach based on similar chemicals
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- other: Weight of evidence approach based on similar chemicals
- Principles of method if other than guideline:
- Weight of evidence approach based on similar chemicals
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence approach based on similar chemicals
- Specific details on test material used for the study:
- - Name of test material: Sodium naphthalene-1-sulfonate
- Molecular formula: C10H7NaO3S
- Molecular weight: 230.218 g/mol
- Smiles notation: c12c(S(=O)(=O)[O-])cccc1cccc2.[Na+]
- InChl: 1S/C10H8O3S.Na/c11-14(12,13)10-7-3-5-8-4-1-2-6-9(8)10;/h1-7H,(H,11,12,13);/q;+1/p-1
- Substance type: Organic
- Physical state: Solid - Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: petroleum jelly
- Concentration / amount:
- 500mg (0.5 g) of 30% (w/w) test chemical diluted in petroleum jelly
- Day(s)/duration:
- 6 hours, once a week, for 3 weeks
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 42.8%
- Day(s)/duration:
- no data available
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: petroleum jelly
- Concentration / amount:
- 0.1 g each of 30%, 10%, 3%, or the petroleum jelly
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 42.8%
- Day(s)/duration:
- No data available
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1. Ten animals were used in the treatment group and 10 in the control group
2. 20 - Details on study design:
- Weight of evidence approach based on the values of structurally similar chemicals
- Challenge controls:
- no data available
- 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 structurally similar read across chemicals and applying the weight of evidence approach, it can be concluded thatSodium naphthalene-1-sulfonatewill also behave in similar manner that of the read across chemicals.Sodium naphthalene-1-sulfonatewas estimated to be not sensitizing to skin.
- Executive summary:
Based on the available studies for the structurally similar read across substances, the weight of evidence approach was applied to determine the extent of dermal sensitization potential of Sodium naphthalene-1-sulfonate.
A delayed contact hypersensitivity test was conducted on Guinea pigs to evaluate the skin sensitization potential of test chemical under occlusive condition.
Ten animals were used in the treatment group and 10 in the control group. During induction, the test site on the flank was clipped and shaved and 500mg (0.5 g) of 30% (w/w) test chemical diluted in petroleum jelly was applied for 6 h under a closed patch, once a week, for 3 weeks. A control site received only the petroleum jelly. Two weeks after the last application, 0.1 g each of 30%, 10%, 3%, or the petroleum jelly were applied to the shaved skin and left for 24 h under a closed patch. Skin reactions were scored on a −, ±, +, ++, +++ scale at 24 and 48 h.
None of the treated animal showed delayed contact hypersensitivity within 48 hours. Thus, the chemical was considered to be not sensitizing in Guinea pigs.
This is supported by the results of a Buehler test conducted according to OECD Guideline 406 to assess the dermal sensitization potential of the structurally similar chemical in Dunkin Hartley guinea pigs. During the test, 20 guinea pigs were used. In induction, the animals were induced dermally at concentration of 42.8 %. After induction animals were challenged dermally with the same concentration under occlusive condition. No known skin reactions were observed at induction as well as at challenge exposure. Thus the chemical was considered to be not sensitizing in Dunkin Hartley guinea pigs.
Based on the available data for the structurally similar read across chemicals and applying the weight of evidence approach, it can be concluded thatSodium naphthalene-1-sulfonatewill also behave in similar manner that of the read across chemicals.Sodium naphthalene-1-sulfonatewas estimated to be not sensitizing to skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Based on the available studies for the structurally similar read across substances, the weight of evidence approach was applied to determine the extent of dermal sensitization potential of Sodium naphthalene-1-sulfonate.
A delayed contact hypersensitivity test was conducted on Guinea pigs to evaluate the skin sensitization potential of test chemical under occlusive condition.
Ten animals were used in the treatment group and 10 in the control group. During induction, the test site on the flank was clipped and shaved and 500mg (0.5 g) of 30% (w/w) test chemical diluted in petroleum jelly was applied for 6 h under a closed patch, once a week, for 3 weeks. A control site received only the petroleum jelly. Two weeks after the last application, 0.1 g each of 30%, 10%, 3%, or the petroleum jelly were applied to the shaved skin and left for 24 h under a closed patch. Skin reactions were scored on a −, ±, +, ++, +++ scale at 24 and 48 h.
None of the treated animal showed delayed contact hypersensitivity within 48 hours. Thus, the chemical was considered to be not sensitizing in Guinea pigs.
This is supported by the results of a Buehler test conducted according to OECD Guideline 406 to assess the dermal sensitization potential of the structurally similar chemical in Dunkin Hartley guinea pigs. During the test, 20 guinea pigs were used. In induction, the animals were induced dermally at concentration of 42.8 %. After induction animals were challenged dermally with the same concentration under occlusive condition. No known skin reactions were observed at induction as well as at challenge exposure. Thus the chemical was considered to be not sensitizing in Dunkin Hartley guinea pigs.
Based on the available data for the structurally similar read across chemicals and applying the weight of evidence approach, it can be concluded thatSodium naphthalene-1-sulfonatewill also behave in similar manner that of the read across chemicals.Sodium naphthalene-1-sulfonate was estimated to be not sensitizing to skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The results of the experimental studies from the structurally similar read across substances indicate a possibility that Sodium naphthalene-1-sulfonate can be not sensitizing to skin.
Hence, by applying the weight of evidence approach, Sodium naphthalene-1-sulfonate can be considered to be not sensitizing to skin. It can be classified under the category “Not Classified” as per CLP regulation.
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