Registration Dossier

Administrative data

Description of key information

The available data for C12-C18 TMAC indicates that the substanace is moderately irritating. However, since the purity of the test substance is not known, extrapolation to pure substance was concluded to be corrosive (Cat. 1C). The available data on eye irritation suggests that the substance causes irreversible effects on the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

A study similar to OECD guideline 404 was conducted to assess the skin irritation potential of C12-C18 TMAC to rabbit skin. Six animals were treated with 0.5 mL undiluted test substance in a semi-occlusive patch (1” X 1” gauze) that was overwrapped with a gauze binder, secured with dermiform tape. Plastic restraint collars were applied and remained on the animals for the duration of the 4 hours followed by removal of the tape and test substance. The Draize classification scoring criteria was used for evaluating the corrosion potential. Application sites were observed for erythema and oedema at 4, 24, 48 and 72 hours after exposure. The primary irritation index was determined to be 5.6. Under the test conditions, C12-C18-TMAC was considered to be moderately irritating to rabbit skin (Nass DJ, 1988).

Eye

A study similar to OECD guideline 405 was conducted to assess the eye irritation potential of C12-C18 TMAC in rabbits. Nine rabbits received 0.1 mL of undiluted solution in one eye. The other eye remained untreated. The eye lids were held close for approximately 1 second after instillation. The eyes of three rabbits were washed for approximately 1minute with 120 mL of lukewarm tap water commencing approximately 30 seconds after dosing. Both eyes were examined at approximately 1, 24, 48 and 72 hours after dosing and at 96 hours and 7, 14 and 21 days. In addition, both eyes of all rabbits were further examined at 72 hours and 7, 14 and 21 days with sodium fluorescein and ultraviolet light. The maximum average score for the test substance were calculated to be 96.8 on Day 14 for the washed group and 69.7 at both 72 and 96 h for the washed group. Under the test conditions, C12-C18 TMAC was considered to cause irreversible effects on the eye (Nass DJ, 1988).


Justification for selection of skin irritation / corrosion endpoint:
Key study

Justification for selection of eye irritation endpoint:
Key study

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Skin

Based on the available in vivo skin irritation study, C12-C18 TMAC is moderately irritating to rabbit skin. Hence, the data derived from the key study justifies R38 classification according to EC criteria (67/548/EEC) and skin irritation category 2; H315-causes skin irritation (hazard statement) according to CLP criteria (EC 1272/2008).

Eye

Based on the availablein vivoeye irritation study, C12-C18 TMAC caused severe eye effects in rabbits which did not reverse within 21 days. Hence, the data derived from the key study justifies Xi; R41 classification according to EC criteria (67/548/EEC) and according to CLP criteria (EC 1272/2008) classification as irreversible effects on the eye category 1; H318 – causes serious eye damage (hazard statement).