Mandelic acid

Skin sensitisation

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

Test guideline 2

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

Test material information

1

Reference substance name:

3-Ethoxy-4,6-difluoro-7-pentyloxy-dibenzofurane

EC Number:

942-871-8

Cas Number:

1799569-89-3

Molecular formula:

C19H20F2O3

IUPAC Name:

3-Ethoxy-4,6-difluoro-7-pentyloxy-dibenzofurane

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

In chemico test system

Details on the 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: 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

Study design: in vivo (LLNA)

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.

Results and discussion

Positive control results:

Conc. SI
0%: 1.00
5% 1.15
10% 2.79
25% 7.84

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

1.9

Test group / Remarks:

Test Group: 10 %

Results 2

Parameter:

SI

Value:

2.03

Test group / Remarks:

Test Group: 25 %

Results 3

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. 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.