Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 224-388-8 | CAS number: 4337-75-1
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
- Remarks:
- Read-across study
- Justification for type of information:
- This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Refer to section 13 for read-across justification.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
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:
- Historically available non-LLNA test
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
- Molecular formula:
- not applicable, substance is a UVCB substance containing several constituents
- 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)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Topical induction: 100 %
Topical challenge: 20%
Challenge
- 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
- 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.
- 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.
- 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.
- 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.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- data not available
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- data not available
- Remarks on result:
- other: data not available
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- data not available
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- data not available
- Remarks on result:
- other: data not available
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the study results, the read-across source substance sodium methyl cocoyl taurate (SMCT) is not a skin sensitizer in the Buehler test.
This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Hence, SMLT is not expected to be a skin sensitiser. - Executive summary:
The skin sensitization potential of the read-across source substance sodium methyl cocoyl taurate (SMCT) 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, SMCT is not a skin sensitizer.
This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Hence, SMLT is not expected to be a skin sensitiser.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
