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Description of key information

For this endpoint information from an experimental study is available. The study was performed according to GLP and the methods applied are fully compliant with OECD TG 429.

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 - September 08, 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. 806913 (DL Mandelic acid)
Expiry Date: 31 May 2020
Storage Conditions: At room temperature
Details on the study design:
According to guideline
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: 9-10 weeks; Main test: 10 - 11 weeks
- Weight at study initiation: Pre-test: 18.8 and 20.3 g; Main test: 18.1 - 19.7 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 (%): 41.5 – 45 %
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: day 1 To: day 6
Vehicle:
dimethylformamide
Concentration:
10, 25, and 50%. (w/w)
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: 50 % in DMF
- 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
Parameter:
SI
Value:
1.9
Test group / Remarks:
Test Group: 10 %
Parameter:
SI
Value:
2.03
Test group / Remarks:
Test Group: 25 %
Parameter:
SI
Value:
1.61
Test group / Remarks:
Test Group: 50 %
Interpretation of results:
not sensitising
Conclusions:
The test item Art. 201386 (B-2O-O5) was not a skin sensitiser under the test conditions of this study.
Executive summary:

The test item Art. 201386 (B-2O-O5) was not a skin sensitiser under the test conditions of this study.

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

Justification for classification or non-classification

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