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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 31 - July 18, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Principles of method if other than guideline:
The following deviations from study plan occurred:
The relative humidity in the animal room was between approximately 33 - 92% instead of 45 – 65% for several hours.
The purity of the trichloroacetate was 99.0% instead of >99.5%.
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymphnode assay (LLNA)

Test material

Reference
Name:
Unnamed
Specific details on test material used for the study:
Designation: Art. 201386
Synonym: B-2O-O5
Batch: EF13004186
Purity (HPLC): 100.0%
Appearance: White, solid
Expiry date: April 30, 2018
Storage: Tightly closed, dark at room temperature (15 to 25°C)


In chemico test system

Details on study design:
According to guideline

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Envigo RMS B.V., Inc. Postbus 6174 NL - 5960 AD Horst
- Age at study initiation: Pre-test: 10-11 weeks; Main test: 8 - 9 weeks
- Weight at study initiation: Pre-test: 22.3 and 20.0 g; Main test: 16.4 - 20.9 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:
dimethylformamide
Concentration:
10, 25, and 50%. (w/w)
No. of animals per dose:
4
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.

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:
1.9
Test group / Remarks:
Test Group: 10 %
Key result
Parameter:
SI
Value:
2.03
Test group / Remarks:
Test Group: 25 %
Key result
Parameter:
SI
Value:
1.61
Test group / Remarks:
Test Group: 50 %

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Conclusions:
The test item Art. 806913 (DL Mandelic acid) was not a skin sensitiser under the test conditions of this study.
Executive summary:

The test item Art. 806913 (DL Mandelic acid) was not a skin sensitiser under the test conditions of this study.