Registration Dossier
Registration Dossier
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EC number: 939-529-5 | CAS number: 1471313-51-5
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:
- other: Guideline study according to GLP
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:
- The LLNA was not available at time of study implementation. Existing data from Buehler study scientifically adequate.
Test material
- Reference substance name:
- Fatty acid chlorides, C12-18 (even numbered) and C18 unsatd., reaction products with sodium N-methyltaurinate
- EC Number:
- 939-529-5
- Cas Number:
- 1471313-51-5
- Molecular formula:
- not applicable
- IUPAC Name:
- Fatty acid chlorides, C12-18 (even numbered) and C18 unsatd., reaction products with sodium N-methyltaurinate
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: 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: 299g (264 - 327 g)
- Housing: Macrolon cages (type 4)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12 hours
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 for test group
10 for control group - Details on study design:
- RANGE FINDING TESTS: yes, determination of primary irritating and non-irritating concentration
- Challenge controls:
- yes, negative control group
- 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:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the study results, sodium cocoyl taurate is not a skin sensitizer in the Buehler test.
- Executive summary:
The skin sensitization potential of sodium cocoyl taurate was evaluated for potential skin sensitizing effects in guinea pigs according to OECD Guideline 406 using the methodology of Buehler. 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 in water as vehicle.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 (sensitization incidence = 0%). Also none of the 10 control animals exhibited skin responses. Based on the results of this study, the test substance is not a skin sensitizer.
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