Registration Dossier
Registration Dossier
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EC number: 263-174-9 | CAS number: 61791-42-2
Skin sensitisation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- 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.
Test material
- Reference substance name:
- Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts
- EC Number:
- 263-174-9
- EC Name:
- Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts
- Cas Number:
- 61791-42-2
- Molecular formula:
- UVCB
- IUPAC Name:
- Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- paste
Constituent 1
In vivo test system
Test animals
- 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
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Topical induction: 100 %
Topical challenge: 20%
Challengeopen allclose all
- 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
Results and discussion
- Positive control results:
- Sensitivity of test system periodically confirmed using alpha-hexylcinnamaldehyde as positive control.
In vivo (non-LLNA)
Resultsopen allclose all
- 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
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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