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

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

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.

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

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 hours

Score:

0.2

Max. score:

1

Reversibility:

fully reversible

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19-22 April 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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

no

Duration of treatment / exposure:

The test item was instilled into the conjunctival sac of the left eye. The eyelids were held closed for several seconds to prevent the loss of the test item.

Observation period (in vivo):

The eyes were examined at 1, 24, 48 and 72 hours after treatment.

Number of animals or in vitro replicates:

3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 hours

The eyes were examined at 1, 24, 48 and 72 hours after the application.

 

Initial Pain Reaction (IPR) (score 1) was observed in two animals.

 

One hour after the application, conjunctival redness (score 1) was observed in two animals.

At 24 hours after treatment, fully recovery was noted.

At 48 hours after treatment, there were no clinical signs observed.

At 72 hours after treatment, there were no clinical signs observed.

 

As there were no clinical signs observed, the study was terminated after the 72 hour observation.

During the study, the control eye of all animals was symptom-free. The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:

chemosis :                  0.00, 0.00, 0.00

discharge :                 0.00, 0.00, 0.00

redness :                    0.00, 0.00, 0.00

cornea opacity :         0.00, 0.00, 0.00

iris :                           0.00, 0.00, 0.00

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is not irritating to eyes

Executive summary:

The primary eye irritation of the neat substance has been assessed in the eyes of New Zealand white rabbits according to the OECD 405 test guideline. The substance initially caused cunjunctival redness of score 1 in two animals at 1 hour. No effects were observed at 24 hours or at any remaining observation point.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Justification for selection of skin irritation / corrosion endpoint:
A single study (Sanders) is available for the assessment. The data is of K1 quality and adequate for hazard assessment and classification of the substance.

Justification for selection of eye irritation endpoint:
A single study (Tavaszi) is available for the assessment. The data is of K1 quality and adequate for hazard assessment and classification of the substance.

Justification for classification or non-classification

A single study (Sanders for skin irritation and Tavaszi for eye irritation) is available for each assessment. The data are of K1 quality and adequate for hazard assessment and classification of the substance.

No adverse reactions were noted in either study to skin or eye beyond the initial 1 hour observation. The substance is therefore Not Classified for irritation (or corrosivity) to skin or eyes.