Registration Dossier

Administrative data

Description of key information

Skin: Irritating but not classified according to CLP (1272/2008/EEC) and 67/548/EEC
Eye: Highly irritating and classified as Seriously eye damaging according to CLP (1272/2008/EEC) and 67/548/EEC

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:
adverse effect observed (irritating)

Additional information

Skin:

In a primary dermal irritation study (key study, Liggett, 1980), rabbits were dermally exposed to 0.5 ml of a structural analogue of the substance, methyl tetrahydrophthalic anhydride (MTHPA), for 72 hours. A mean erythema score (24/72 h) calculated over all 6 animals for intact skin of 2 and for abraded skin of 1.58 was observed. The oedema score was determined to be 1.92 for intact skin and 1.50 for abraded skin. Taking the test conditions into account, in particular the 24 hour exposure period compared with 4 hours of current test methods (described in OECD TG 404), MTHPA has not to be classified and labelled as a dermal irritant according to CLP (1272/2008/EEC), and according to 67/548/EEC (DSD). In a primary dermal irritation report (supporting study, Smyth, 1969), rabbits were dermally exposed to Methyl tetrahydrophthalic anhydride (MTHPA) on the belly. In this report, MTHPA is not a dermal irritant. The irritant score of MTHPA is 1 of 6, which means minimal irritating to the skin.

 

Eye:

In a primary eye irritation study (key study, Irie, 1969), 0.1 ml of a structural analogue of the substance, methyl tetrahydrophthalic anhydride (MTHPA), was instilled into the conjunctival sac of Belgian Hare. Animals then were observed for 10 days. The response to treatment requires MTHPA to be classified as seriously eye damaging according to CLP (1272/2008/EC).

In a supporting primary eye irritation study (Smyth, 1969), MTHPA was instilled into the conjunctival sac of rabbits eyes. An irritation score of 9 (maximum score 10) was determined. Thus, MTHPA was considered to be seriously eye damaging.


Effects on eye irritation: highly irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Skin:

Based on the results of the presented in the skin irritation studies the test substance was not classified and labelled according to Regulation 1272/2008/EC (CLP) nand Directive 67/548/EEC (DSD).

Eyes:

Based on the results of the available eye irritation studies, tetrahydromethylphthalic anhydride (MTHPA) was classified as eye damaging category 1 with labelling of H318: causes serious eye damage according to CLP (1272/2008/EC) and as seriously eye damaging (Xi, R41) according to 67/548/EEC.