Registration Dossier
Registration Dossier
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EC number: 294-955-2 | CAS number: 91771-62-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cyperus scariosus, Cyperaceae.
Endpoint summary
Administrative data
Description of key information
Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Cyperus scariosus, ext. was estimated to be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,Cyperus scariosus, ext.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:
- other: weight of evidence approach based on structurally similar chemicals
- Justification for type of information:
- Weight of evidence approach based on structurally 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 report based on structurally similar chemicals
- Principles of method if other than guideline:
- The weight of evidence report has been prepared based on the read across substances identified based on structural and functional similarity to assess the dermal sensitization potential of Cyperus scariosus, ext.
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence approach based on structurally similar chemicals
- Specific details on test material used for the study:
- - Name of test material: Cyperus scariosus, ext.- Common name: Nagarmotha essential oil- Substance type: Organic- Physical state: Liquid
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- male
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 4%
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5% in petrolatum
- Day(s)/duration:
- five alternate-day 48-hr periods
- Adequacy of induction:
- other: Patch sites were pre-treated for 24 hr with 5% aqueous sodium lauryl sulfate (SLS) under occlusion for the initial patch only
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 4% in petrolatum
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5% in petrolatum
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- other: Challenge applications were preceded by 30-min applications of 5% aqueous SLS under occlusion on the left side whereas the test material was applied without SLS treatment on the right side
- No. of animals per dose:
- 1. 252. 25 male volunteers
- Details on study design:
- The study is based on weight of evidence approach from the read across values
- Challenge controls:
- no data available
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 25
- 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 substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Cyperus scariosus, ext. was estimated to be not sensitizing to skin. Comparing the above annotations with the criteria of CLP regulation,Cyperus scariosus, ext.can be classified under the category “Not Classified”.
- Executive summary:
Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal sensitization potential of Cyperus scariosus, ext.
A human maximization test was carried out to assess the dermal sensitization potential of the structurally similar chemical. The test chemical 4% in petrolatum was applied to the skin of 25 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified). The test chemical 4% in petrolatum did not induce any sensitization reactions on the skin of 25 human volunteers.
Hence, the test chemical was considered to be not sensitizing to skin.
This is supported by the results of a human maximization test carried out to assess the dermal sensitization potential of other structurally similar chemical. Patch sites were pre-treated for 24 hr with 5% aqueous sodium lauryl sulfate (SLS) under occlusion for the initial patch only. The test concentration of 5% was based on a reported maximum use concentration of 0.5% in consumer products. 5% test chemical in petrolatum was applied under occlusion to the same site on the forearms of 25 healthy male volunteers for five alternate-day 48-hr periods. After a rest period of 10-14 days, challenge exposure was carried out. Challenge applications were preceded by 30-min applications of 5% aqueous SLS under occlusion on the left side whereas the test material was applied without SLS treatment on the right side. Challenge patches were applied under occlusion to fresh sites for 48 hr.
The test sites were evaluated after 48 hours of challenge exposure.
No reactions were produced that were considered significantly irritant or allergic to human skin. Hence, the test chemical was considered to be not sensitizing to skin.
Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Cyperus scariosus, ext. was estimated to be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,Cyperus scariosus, ext.can be classified under the category “Not Classified”.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal sensitization potential of Cyperus scariosus, ext.
A human maximization test was carried out to assess the dermal sensitization potential of the structurally similar chemical. The test chemical 4% in petrolatum was applied to the skin of 25 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified). The test chemical 4% in petrolatum did not induce any sensitization reactions on the skin of 25 human volunteers.
Hence, the test chemical was considered to be not sensitizing to skin.
This is supported by the results of a human maximization test carried out to assess the dermal sensitization potential of other structurally similar chemical. Patch sites were pre-treated for 24 hr with 5% aqueous sodium lauryl sulfate (SLS) under occlusion for the initial patch only. The test concentration of 5% was based on a reported maximum use concentration of 0.5% in consumer products. 5% test chemical in petrolatum was applied under occlusion to the same site on the forearms of 25 healthy male volunteers for five alternate-day 48-hr periods. After a rest period of 10-14 days, challenge exposure was carried out. Challenge applications were preceded by 30-min applications of 5% aqueous SLS under occlusion on the left side whereas the test material was applied without SLS treatment on the right side. Challenge patches were applied under occlusion to fresh sites for 48 hr.
The test sites were evaluated after 48 hours of challenge exposure.
No reactions were produced that were considered significantly irritant or allergic to human skin. Hence, the test chemical was considered to be not sensitizing to skin.
Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Cyperus scariosus, ext. was estimated to be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,Cyperus scariosus, ext.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 structurally similar read across substances indicate a possibility that Cyperus scariosus, ext. acetates can be not sensitizing to skin.
Hence by applying the weight of evidence approach, Cyperus scariosus, ext. 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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