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EC number: 203-483-8 | CAS number: 107-35-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 18 - October 10, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Taurine
- EC Number:
- 203-483-8
- EC Name:
- Taurine
- Cas Number:
- 107-35-7
- Molecular formula:
- C2H7NO3S
- IUPAC Name:
- 2-aminoethanesulfonic acid
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- Identification: Art. 808616 (Taurine)
Expiry Date: 30 Sep 2020
Storage Conditions: At room temperature
Appearance: white crystalline powder
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands B.V. Postbus 6174 NL - 5960 AD Horst
- Age at study initiation: Pre-test: 8-9 weeks; Main test: 10 - 11 weeks
- Weight at study initiation: Pre-test: 20.4 and 20.7 g; Main test: 17.6 - 21.2 g
- Housing: grouped per dose
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2°C
- Humidity (%): 45 – 65 %
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: day 1 To: day 6
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 5, 10, and 25%. (w/w)
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: 10, and 25 % in PG
- Irritation: No
- Lymph node proliferation response: -
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD 429
- Criteria used to consider a positive response: Stimulation index > 3
TREATMENT PREPARATION AND ADMINISTRATION: - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Standard statistical methods have been applied for data processing.
Results and discussion
- Positive control results:
- Conc. SI
0%: 1.00
5% 1.15
10% 2.79
25% 7.84
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.94
- Test group / Remarks:
- Test Group: 5 %
- Parameter:
- SI
- Value:
- 2.37
- Test group / Remarks:
- Test Group: 10 %
- Parameter:
- SI
- Value:
- 1.74
- Test group / Remarks:
- Test Group: 25 %
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- The test item Art. 808616 (Taurine) was not a skin sensitiser under the test conditions of this study.
- Executive summary:
The test item Art. 808616 (Taurine) was not a skin sensitiser under the test conditions of this study.
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