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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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.
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

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 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
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:
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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.


Migrated from Short description of key information:
The registered substance does not induce any signs of sensitization in animals when evaluated in the Buehler test. The sensitization incidence was 0 %.

Justification for selection of skin sensitisation endpoint:
Guideline study according to GLP. No derivations and/or confounders. Klimisch rating 1 representing reliability without restrictions. Information is valid and meet data requirements.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

The registration substance is not a skin sensitizer. None of the available toxicological data and known exposure conditions indicates concern that it may possess respiratory sensitization properties.


Migrated from Short description of key information:
The registration substance is not a skin sensitizer. None of the available toxicological data and known exposure conditions indicates concern that it may pose a respiratory sensitization risk.

Justification for classification or non-classification

Based on all available data the registered substance is not a skin sensitiser and therefore is not subject for classification and labelling requirements.