Esterification products of dihydrofuran-2,5-dione, C16-24 (even numbered) alkenyl with propane-1,2,3-triol and propane-1,2,3-triol oligomers

Endpoint summary

Description of key information

Skin: The  test  item  produced  a  primary  irritation  index  of  3.3.  No  corrosive  effects  were noted. The test item is not classifiable under CLP.
In accordance with EU CLP Regulation (EC) No. 1272/2008 classification of this substance is not required for dermal irritation because scores for erythema and edema did not fulfill the criteria for classification. In addition  the primary effects, erythema and edema, were  fully reversible by the end of the 7-day observation period. 
Eye: A single application of the test item to the non-irrigated eye of two rabbits produced minimal conjunctival irritation. Both treated eyes appeared normal at the 72-Hour observation. The test item produced a maximum group mean score of 6.0. The substance is not an eye irritant in rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin

Test Guidance

OECD Guideline No. 404 and EU Method B4

Introduction

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit.

Method and materials

On the day before the test two rabbits were clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study. On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 mL of the test item was applied directly to the skin under a 2.5 cm x 2.5 cm cotton gauze patch. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period. Four hours after application the corset and patches were removed from each animal and any residual test item removed by gentle swabbing with cotton wool soaked in distilled water. Immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the Draize scheme.

Results

A single 4-Hour, semi-occluded application of the test item to the intact skin of two rabbits produced well-defined erythema, very slight or slight edema and loss of skin elasticity. The dermal reactions were completely reversible, starting on Day 3, and both treated skin sites appeared normal at the 7-Day observation.

Conclusion

The test item produced a primary irritation index of 3.3. No corrosive effects were noted. The substance is not a skin irritant in rabbits.

Eye

Introduction

The study was performed in accordance with OECD Guideline No. 405 to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit.

Method

A volume of 0.1 mL of the test item was placed into the conjunctival sac of the right eye, formed by gently pulling the lower li d away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test item, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test item, an assessment of the initial pain reaction was made. Eight hours after test item application, a subcutaneous injection of post-dose analgesia, buprenorphine 0.01 mg/kg and meloxicam 0.5 mg/kg, was administered to provide a continued therapeutic level of systemic analgesia. The treated animal was checked for signs of pain and suffering approximately 0.5 hours later. No further analgesia was required. After consideration of the ocular responses produced in the first treated animal, a second animal was similarly treated. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation (Draize, J.H, 1977).

Results

A single application of the test item to the non-irrigated eye of two rabbits produced minimal conjunctival irritation. Both treated eyes appeared normal at the 72-Hour observation.

Conclusion

The test item produced a maximum group mean score of 6.0. The substance is not an eye irritant in rabbits.

Justification for selection of skin irritation / corrosion endpoint:
GLP study following OECD guideline test method, Klimisch grade 1

Justification for selection of eye irritation endpoint:
GLP study following OECD guideline test method, Klimisch grade 1

Justification for classification or non-classification

Moderate skin irritation effects were fully reversible within 7 days so the test item is not classifiable under CLP.

Mild eye irritation effects were fully reversible within 72 hours so the test item is not classifiable under CLP.