Registration Dossier
Registration Dossier
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EC number: 254-599-0 | CAS number: 39711-79-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- 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
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from safety assessment report
- Qualifier:
- according to guideline
- Guideline:
- other: open repetitive dermal test
- Principles of method if other than guideline:
- An open repetitive dermal test of the test chemical was conducted on guinea pigs to examine the contact sensitization caused by the chemical.
- GLP compliance:
- not specified
- Type of study:
- other: open repetitive dermal test
- Justification for non-LLNA method:
- not specified
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
- Route:
- epicutaneous, open
- Vehicle:
- not specified
- Concentration / amount:
- not specified
- Day(s)/duration:
- 5 days
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- not specified
- Concentration / amount:
- not specified
- Day(s)/duration:
- 3 days
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 15
- Exposure period: 30 seconds
- Test groups: 20
- Control group: No data
- Site: shaved skin
- Frequency of applications: once daily for 3X5 days
- Duration: 5 days
- Concentrations: no data
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 3 days
- Exposure period: 24 hours
- Test groups: 20
- Control group:
- Site: untreated part of the skin
- Concentrations: no data
- Evaluation (hr after challenge): after 24 h, 2 and 3 days. - Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- No data
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No skin sensitizing effects were observed.
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- \No known signs of skin sensitization were observed in treated guinea pigs during the 3 days observation period. Hence the test chemical was considered to be not sensitizing to the skin of guinea pigs.
- Executive summary:
An open repetitive dermal test of the test chemical was conducted on guinea pigs to examine the contact sensitization caused by the chemical. 20 guinea pigs were used for the study.
The test chemical was rubbed into shaved skin for 30 sec once daily for 3x5 days. After 5 days without application, the test substance was rubbed into an untreated part of the skin. Skin lesions were examined after 24 h, 2 and 3 days.
\No known signs of skin sensitization were observed in treated guinea pigs during the 3 days observation period. Hence the test chemical was considered to be not sensitizing to the skin of guinea pigs.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journal
- Qualifier:
- according to guideline
- Guideline:
- other: Human maximisation test
- Principles of method if other than guideline:
- A Human maximisation test was carried out in 25 volunteers to determine skin sensitization potential caused by the test chemical
- GLP compliance:
- not specified
- Type of study:
- other: Human maximisation test
- Justification for non-LLNA method:
- not specified
- Species:
- other: human
- Strain:
- other: Not applicable
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- 8%
- Day(s)/duration:
- No data available
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8%
- Day(s)/duration:
- No data available
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 25
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 8%
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- No signs of sensitization was observed.
- Remarks on result:
- no indication of skin sensitisation
- Cellular proliferation data / Observations:
- No signs of sensitization were observed.
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- None of the volunteers showed any signs of contact sensitization. Hence the test chemical was considered to be not sensitizing to the skin of human volunteers.
- Executive summary:
A Human maximisation test was carried out to determine skin sensitization potential caused by the test chemical.
The test chemical 8% 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).
None of the volunteers showed any signs of contact sensitization. Hence the test chemical was considered to be not sensitizing to the skin of human volunteers.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journal
- Qualifier:
- according to guideline
- Guideline:
- other: Human maximisation test
- Principles of method if other than guideline:
- A Human maximisation test was conducted on 24 volunteers to assess the skin sensitization potential of test chemical
- GLP compliance:
- not specified
- Type of study:
- other: Human maximisation test
- Justification for non-LLNA method:
- not specified
- Species:
- other: human
- Strain:
- other: Not applicable
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- 8%
- Day(s)/duration:
- No data available
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8%
- Day(s)/duration:
- No data available
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 24
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 8%
- No. with + reactions:
- 0
- Total no. in group:
- 24
- Clinical observations:
- No signs of sensitization was observed.
- Remarks on result:
- no indication of skin sensitisation
- Cellular proliferation data / Observations:
- No signs of sensitization were observed.
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- Since the chemical not induce any skin sensitizing effects in treated volunteers, the test chemical was considered to be not sensitizing to theskin of 24 human volunteers.
- Executive summary:
Human maximisation test was conducted on 24 volunteers to assess the skin sensitization potential of test chemical.
Each subject was treated with 8% in petrolatum dermally and later observed for any signs of contact allergy. Since the chemical not induce any skin sensitizing effects in treated volunteers, the test chemical was considered to be not sensitizing to the skin of 24 human volunteers.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- WoE report Dermal Sensitization Potential of the test chemical
- Author:
- Sustainability Support Services (Europe)
- Year:
- 2 018
- Bibliographic source:
- Sustainability Support Services (Europe), 2018
Materials and methods
Test guideline
- 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:
- not specified
Test material
- Reference substance name:
- N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide
- EC Number:
- 254-599-0
- EC Name:
- N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide
- Cas Number:
- 39711-79-0
- Molecular formula:
- C13H25NO
- IUPAC Name:
- N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide
- Molecular formula: C13H25NO
- Molecular weight: 211.346 g/mol
- Smiles notation: C1[C@@H](CC[C@@H](C(C)C)[C@@H]1C(NCC)=O)C
- InChl: 1S/C13H25NO/c1-5-14-13(15)12-8-10(4)6-7-11(12)9(2)3/h9-12H,5-8H2,1-4H3,(H,14,15)
- Substance type: organic
- Physical state: Solid powder (white)
- Purity: 98%
Constituent 1
In vivo test system
Test animals
- Species:
- other: 1. guinea pigs; 2,3. humans
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted
- Day(s)/duration:
- 30 sec once daily for 3x5 days
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8%
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8%
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1. 20 guinea pigs
2. 25 volunteers
3. 24 volunteers - 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
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- No. with + reactions:
- 0
- Clinical observations:
- no dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- 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.
An open repetitive dermal test of the test chemical was conducted on guinea pigs to examine the contact sensitization caused by the chemical. 20 guinea pigs were used for the study.
The test chemical was rubbed into shaved skin for 30 sec once daily for 3x5 days. After 5 days without application, the test substance was rubbed into an untreated part of the skin. Skin lesions were examined after 24 h, 2 and 3 days.
No known signs of skin sensitization were observed in treated guinea pigs during the 3 days observation period. Hence the test chemical was considered to be not sensitizing to the skin of guinea pigs.
This is supported by the results of a human maximisation test carried out to determine skin sensitization potential of the test chemical. The test chemical 8% 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).
None of the volunteers showed any signs of contact sensitization. Hence the test chemical was considered to be not sensitizing to the skin of human volunteers.
These results are further supported by another Human maximisation test conducted on 24 volunteers to assess the skin sensitization potential of test chemical. Each subject was treated with 8% in petrolatum dermally and later observed for any signs of contact allergy. Since the chemical not induce any skin sensitizing effects in treated volunteers, the test chemical was considered to be not sensitizing to the skin of 24 human volunteers.
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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