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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 May and 08 June 2003

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:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

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

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The animals were individually housed in suspended metal cages. Free access to mains drinking water and food (Certified Rabbit Diet (Code 5322) supplied by International Product Supplies Limited, Wellingborough, Northants, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Three suitable sites were selected on the back of the rabbit. At each test site a quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset and the animal was returned to its cage for the duration of the exposure period.

Duration of treatment / exposure:

One patch was removed at each of three time points: 3 minutes, 1hour and 4 hours after application. Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.

Observation period:

Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later

Number of animals:

3

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 hours

Score:

0.2

Max. score:

1

Reversibility:

fully reversible

Any other information on results incl. tables

Individual Skin Reactions Following 4-Hour Exposure

Skin Reaction     Observation Time   Individual Scores-Rabbit Number and Sex       Total     17 Male   87 Male   88 Male       Erythema/Eschar Formation 1 Hour   24 Hours   48 Hours   72 Hours 0   1   0   0 0   0   0   0 1   0   0   0 (1)   1   (0)   0       Oedema Formation 1 Hour   24 Hours   48 Hours   72 Hours 0   0   0   0 0   0   0   0 0   0   0   0 (0)   0   (0)   0 Sum of 24 and 72-hour Readings (S)         :              1 Primary Irritation Index (S/6)                                         1/6 = 0.2 Classification                                                           MILD IRRITANT

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is not irritating to skin

Executive summary:

The primary irritation has been assessed by application of the neat substance to the intact clipped skin of New Zealand white rabbits according to the OECD 404 test method. The substances cause no significant or un reversible skin reactions and is classified as non-irritant.