Registration Dossier

Administrative data

Description of key information

For the test item Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol is no study available. However, it is likely that the studies conducted on the component diisotridecyl adipate and the read-across substance bis (2 -ethylhexyl) adipate and Diisotridecyl dodecanedioate are valid for Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol (please see justification for read-across). The component Diisotridecyl adipate is not irritating either to skin or to the eye (Mobil, 1978a and c). The analogue Diisotridecyl dodecanedioate is only slightly irritant to the skin (Zeneka, 1995).

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

For the test item Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol is no study available. However, it is likely that the studies conducted on the component diisotridecyl adipate and the read-across substance bis (2 -ethylhexyl) adipate and diisotridecyl dodecanedioate are valid for Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol (please see justification for read-across). Four studies have been identified relating to the irritation/corrosion potential of the component diisotridecyl adipate and one with the analogue diisotridecyl dodecanedioate. Two of them are GLP guideline studies with RL2. Consistently no irritating effects could be observed.

Skin irritation /corrosion

In a valid primary dermal irritation study according to OECD TG 404, 3 male young adult White Vienna rabbits were dermally exposed to 0.5 mL diisotridecyl adipate. The test substance was administered for 4 h soaked on a test patch of 2.5 x 2.5 cm and held in place by semiocclusive dressing. Animals then were observed for 8 days.

For all three rabbits, only very slight erythema were observed. They fully disappeared within 1 to 8 days. Edema were not observed at all after treatment.

In this study, diisotridecyl adipate is not irritating to the skin of rabbits (Rossbacher/BASF, 1992a).

The read-across substance diethylhexyl adipate was in one study slightly irritating to the skin of rabbits, in some other tests it showed no irritating effects (BUA; 1997). The analogue is not classified.

The analogue diisotridecyl dodecanedioate was in one study slightly irritating to the skin of rabbits. All signs of irritation had completely regressed three days after application of the test sample (Zeneka, 1995).

Eye Irritation

In a valid primary eye irritation study according to OECD TG 405, 0.1 mL of diisotridecyl adipate was instilled into the conjunctival sac of one eye of each of 3 adult Vienna White rabbits for 24 hours. Eyes were not washed at the end of the exposure period. Eye irritation was scored 1 h, 24 h, 48 h, 72 h and 8 d after instillation of the test substance using the grading system of OECD test guideline 405 (Acute Eye Irritation/Corrosion). Animals then were observed for 72 h or 8 days dependent on the results of the test.

After treatment, only week effects on conjunctivae could be observed. No reaction was seen for cornea, iris, and chemosis. Conjunctival effects subsided with time and were fully absent after 48 h, 72 h and 8 d for rabbit 2, 3 and 1 respectively.

In this study, diisotridecyl adipate is not irritating to the eye according to EU regulations (Rossbacher/BASF 1992b).

The read-across substance diethylhexyl adipate showed no irritating properties in a test on rabbits.

Zeneka Central Toxicology Laboratory, 1995, Skin irritation study in the rabbit, CTL Report No CTL/L/6461

Justification for classification or non-classification

Skin irritation/corrosion

According to EU legislation (Directive 67/548/EEC and Regulation (EC) No 1272/2008), Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol has not to be classified for skin irritation based on results above.

Eye irritation

According to EU legislation (Directive 67/548/EEC and Regulation (EC) No 1272/2008) Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol has not to be classified for eye irritation based on results above.