Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:
Migrated from Short description of key information:
There is no available information on animals. Several occupational sensitization cases by inhalation at processing sites were reported. Tetrahydro-4-methylphthalic anhydride (4-MTHPA) is classified due to human case reports and due to its chemical structure as skin sensitising cat.1 and respriatory sensitising cat.1 according to CLP (1272/2008/EC).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

There is no available information on animals. Two recommendations from Japanese and German commissions/societies are available, both concluding that tetrahydromethylphthalic anhydride (MTHPA) is sensitising to the respiratory tract. This fact could be based on the structure of the substance and several occupational case reports:

- MTHPA was classified as "Sa", danger of sensitization of airways by the German MAK commission (Commission for the investigation of health hazards of chemical compounds in the work area). Substances classified as "Sa" can cause symptoms of the airways and also of the conjunctiva (substances causing airway sensitization).

- The Japan society of occupational health has recommended 50 ug/m3 as a limit for exposure to MTHPA during an 8 hr work shift. The cause of this value was respiratory sensitisation.


Migrated from Short description of key information:
There is no available information on animals. Several occupational sensitization cases by inhalation at processing sites were reported. Tetrahydro-4-methylphthalic anhydride (4-MTHPA) is classified due to human case reports and due to its chemical structure as skin sensitising cat.1 and respriatory sensitising cat.1 according to CLP (1272/2008/EC).

Justification for classification or non-classification

There is no available information on animals. Several occupational sensitization cases by inhalation at processing sites were reported. Tetrahydro-4 -methylphthalic anhydride (4 -MTHPA) is classified and labelled based on its chemical structure and available human case reports as skin sensitising cat.1 and respriatory sensitising cat.1 according to Regulation 1272/2008/EC (CLP) and Xn, R42/43 (May cause sensitisation by inhalation and skin contact) according to Directive 67/548/EEC (DSD).