Registration Dossier
Registration Dossier
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EC number: 263-174-9 | CAS number: 61791-42-2
Endpoint summary
Administrative data
Description of key information
Skin sensitisation (in vivo, OECD 406, Bühler): not sensitising
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An in vivo skin sensitisation study is available that was performed prior to 1 June 2008. In accordance with Regulation (EC) No. 1907/2006, the data were included to avoid unnecessary testing.
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG. SPF breeding (Hoe:DHPK[SPFLac])
- Weight at study initiation: 299 g (264 - 327 g)
- Housing: Macrolon cages (type 4)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Topical induction: 100 %
Topical challenge: 20% - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Topical induction: 100 %
Topical challenge: 20% - No. of animals per dose:
- 20 (test group)
10 (control group) - Details on study design:
- RANGE FINDING TESTS: yes, determination of primary irritating and non-irritating concentration
- Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
- Positive control results:
- Sensitivity of test system periodically confirmed using alpha-hexylcinnamaldehyde as positive control.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- no reading
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Ethanesulfonic acid, 2 -(methylamino)-, N-coco acyl derivs., sodium salts was evaluated for potential skin sensitising effects in guinea pigs according to OECD Guideline 406 under GLP conditions using the methodology of Buehler (Clariant, 1994). Dermal induction was performed using 100% test material. The control group was exposed to the vehicle water only. Challenge treatment was carried out using a 20% test material solution (in water). Under the conditions of the present study, none of the 20 animals of the treatment group showed a positive skin response after the challenge procedure (sensitisation incidence = 0%). Also none of the 10 control animals exhibited skin responses. Sensitivity of the test system is periodically confirmed using alpha-hexylcinnamaldehyde as positive control. Based on the results of this study, the test substance is considered to not be a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation of the test substance do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification.
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