Pentaerythritol, reaction product with fatty acids, C8 to 18 (even numbered) and/or branched and/or unsaturated

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 22 - September 03, 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD guidelines and according to GLP principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

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)

Deviations:

no

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material Pentaerythritol, reaction product with fatty acids, C8 to 18 (even numbered) and/or branched and/or unsaturated
- Physical state: Pale yellow liquid
- Analytical purity: Not indicated
- Lot/batch No.: OE70406
- Expiration date of the lot/batch: 06 April 2011
- Stability under test conditions: Stable
- Storage condition of test material: In refrigerator (2-8ºC) in the dark

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River France
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 21 - 26 g
- Housing: Individual housing in labeled Macrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.4- 22.9
- Humidity (%): 40 - 79
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

Test substance concentrations of 0%, 25%, 50% or 100%

No. of animals per dose:

5

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: Acetone/Olive oil (4:1 v/v).
- Irritation: Slight erythema was observed in in both ears of animals at 50 and 100%. No oedema was observed in any of the animals examined.
- Lymph node proliferation response: no

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Induction
- Criteria used to consider a positive response: The six monthly reliability check is carried out to check the sensitivity of the test system and the reliability of the experimental techniques.

TREATMENT PREPARATION AND ADMINISTRATION:
In the main study, three groups of five experimental animals (Mouse, CBA strain, all females) were treated with test substance concentrations of 25%, 50% or 100% on three consecutive days, by open application on the ears (25 µl/ear). Five vehicle control animals were similarly treated, but with vehicle alone (Acetone/Olive oil (4:1 v/v)). Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised. After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of Disintegrations Per Minute (DPM) and a stimulation index (SI) was subsequently calculated for each group.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:

The SI values calculated for the substance concentrations 5, 10 and 25% were 1.3, 1.5 and 5.5 respectively. An EC3 value of 15.6% was calculated using linear interpolation.
The calculated EC3 value was found to be in the acceptable range of 2 and 20%. The results of the 6 monthly HCA reliability checks of the recent years were 7.3, 10.3, 9.5 and 13.1%.

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: see Remark

Remarks:

The SI values calculated for the substance concentrations 25, 50 and 100% were 1.1, 1.6 and 3.3 respectively. These results indicate that the test substance could elicit an SI  3. The data showed a dose-response and an EC3 value of 91.2% was calculated.

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Mean DPM/animal values for the experimental groups treated with test substance concentrations 25, 50 and 100% were 646, 938 and 1939 respectively. The mean DPM/animal value for the vehicle control group was 579.

Any other information on results incl. tables

Slight erythema was observed in one or both ears of animals at 25% and in both ears of animals at 50 and 100%. No oedema

was observed in any of the animals examined. The irritation of the ears as shown by the animals, was considered not to

have a toxicologically significant effect on the activity of the nodes.

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information

Conclusions:

Pentaerythritol, reaction product with fatty acids, C8 to 18 (even numbered) and/or branched and/or unsaturated should be classified as skin sensitizer (Category 1).