Hexanedioic acid, mixed benzyl and 2-(2-methoxyethoxy)ethyl diesters

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 January -19 January 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Data is based on GLP compliant data accordingly to internationally recognised and EU guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (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

Constituent 1

Reference substance name:

Reaction mass of benzyl 2-(2-methoxyethoxy)ethyl adipate and bis[2-(2-methoxyethoxy)ethyl] adipate and dibenzyl adipate

EC Number:

940-202-4

Cas Number:

1175612-76-6

Molecular formula:

Cannot be assigned to the reaction mass

IUPAC Name:

Reaction mass of benzyl 2-(2-methoxyethoxy)ethyl adipate and bis[2-(2-methoxyethoxy)ethyl] adipate and dibenzyl adipate

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

Housing / Enrichment: Individual caging / mice were provided with glass tunnel-tubes
Cage type: Type II. polypropylene/ polycarbonate
Bedding: Bedding was available to animals during the study
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Ventilation: 15-20 air exchange/hour
Food and water ad libitum

Study design: in vivo (LLNA)

Vehicle:

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

Concentration:

0, 10, 25 and 50%

No. of animals per dose:

4

Details on study design:

The Preliminary Irritation/Toxicity Test was performed in CBA/J mice using two doses (test item concentrations of 50 and 25 (w/v) %). This preliminary experiment was conducted in a similar experimental manner to the main study, but it was terminated on Day 6 with a body weight measurement (radioactive proliferation assay was not performed).
During the Preliminary Irritation/Toxicity Test no mortality was observed in any treatment groups. No significant body weight loss was observed in the treated groups.

Positive control substance(s):

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

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: Measured SI (group) 0% : 1.0 10% : 1.1 25% : 1.8 50% : 0.7

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Measured DPM (group) 0% : 840 10% : 933 25% : 1497 50% : 591

Any other information on results incl. tables

The test item was a colorless clear liquid which was dissolved in AOO. Since there were no confounding effects of irritation or systemic toxicity at the applied concentrations, the proliferation values obtained are considered to reflect the real potential of the test item to cause lymphoproliferation in the Local Lymph Node Assay. The lack of any positive result under these exaggerated test conditions is considered to be good evidence that the substance is not a sensitizer.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is non sensitising.

Executive summary:

The sensitisation of the substance has been assessed according to the OECD 429 LLNA test method in the CBA mouse at test concentrations of 0, 10, 25 and 50% in Acetone Olive Oil (4:1). No irritation or systemic toxicity was observed at any test concentration and none of the responses of the test substance met the criteria for being a positive result. The substance is therefore non-sensitising