Registration Dossier

Administrative data

Description of key information

For this endpoint, an experimental GLP compliant assay was performed according to OECD TG 429.

The data are documented in the robust summary and the result of this assay is shown below.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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)
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
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
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.
Positive control results:
Conc. SI
0%: 1.00
5% 1.15
10% 2.79
25% 7.84
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 %
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.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No classification is needed.