Registration Dossier

Administrative data

Description of key information

Key in vivo studies were performed for skin and eye irritation in New Zealand White rabbits. Slight irritation was only observed at 1h after application, however was cleared after 24 hours. 

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

A key study for acute dermal irritation/corrosion potential was performed in female New Zealand White rabbits (IIBAT, 2012c). A volume of 0.5 ml of test substance was evenly applied as such to the 6cm2 clipped skin area on the left side of the rabbits under a gauze patch. The right untreated side was kept as control area. At the end of 4th, the gauze patch was removed and application site was wiped with water without altering the integrity of the epidermis to remove the residual test substance. First in one animal, then repeated in 2 additional animals. The test site was covered with semi occlusive gauze patch. Animals were observed for erytema and oedema at 60 minutes, 24, 48 and 72h following the removal of gauze patch. Initial and confirmatory test animals exhibited very slight erythema at 60 minutes and completely cleared at 24h observation period. The acute dermal irritation (Primary Irritation) Index was calculated as 0.25 (including the 1h observation) and 0 (excluding the 1h observation). No dermal reaction was seen in untreated area of initial and confirmatory test animals. Hence, it was concluded that the test substance Proviplast 0142 (bis(2 -butoxyethyl)adipate) was slightly irritating to the skin of New Zealand white rabbits under the experimental conditions tested, however below threshold of classification.

A key acute eye irritation/corrosion study was performed in female New Zealand white rabbits (IIBAT, 2012d). In the test 0.1 ml of test substances was instilled into the conjunctival sac of the left eye of one rabbit, followed by confirmation in 2 additional rabbits. The right eye of the rabbits served as the control. The eyes of initial and confirmatory test animals were examined and ocular lesions were graded after instillation of the test substance at 1, 24, 48 and 72h. The ocular irritation potential was evaluated by Draize's method. Test substance treated eye (left) of initial and confirmatory test animals exhibited conjunctival lesions at 1 hour, and cleared at 24h of the observation period. The maximum mean score for ocular lesions observed in the experiment was 4.00 +/- 0.0 only at 1 hour after instillation. Hence, under the experimental conditions the test substance, bis(2 -butoxyethyl)adipate, was minimally irritating to the eyes of the New Zealand white rabbits, however below the threshold of classification.

Justification for classification or non-classification

Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC) and CLP regulation (EC No. 1272/2008 of 16 December 2008), Bis(2-butoxyethyl)adipate (Proviplast 0142/DBEA) does not have to be classified and has no obligatory labelling requirement for skin irritation and eye irritation.