Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Data waiving:
other justification
Justification for data waiving:
other:
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. Tetrahydromethylphthalic anhydride (MTHPA) is classified due to human case report and due to its chemical structure skin sensitising cat.1 and respriatory sensitising cat.1 according to Annex VI of CLP (1272/2008/EC).

Justification for selection of skin sensitisation endpoint:
There is no available information on animals. Several occupational sensitization cases by inhalation at processing sites were reported. Tetrahydromethylphthalic anhydride (MTHPA) is classified due to human case report and due to its chemical structure skin sensitising cat.1 and respiratory sensitising cat.1 according to Annex VI of CLP (1272/2008/EC).

Respiratory sensitisation

Link to relevant study records
Reference
Endpoint:
respiratory sensitisation
Remarks:
other: based on human data
Type of information:
other: Review
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: MAK review
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
no guideline available
Principles of method if other than guideline:
not applicable
GLP compliance:
no
Species:
human
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no details given
Route of induction exposure:
inhalation
Route of challenge exposure:
inhalation
Vehicle:
not specified
Concentration:
no details given
No. of animals per dose:
no details given
Details on study design:
no details given
Challenge controls:
no details given
Results:
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).
Positive control results:
no details given
Negative control results:
no details given

no details given

Interpretation of results:
sensitising
Conclusions:
Tetrahydromethylphthalic anhydride (MTHPA) classified as sensitising to the respiratory tract.
Executive summary:
Tetrahydromethylphthalic anhydride (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).
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. Tetrahydromethylphthalic anhydride (MTHPA) is classified due to human case report and due to its chemical structure skin sensitising cat.1 and respriatory sensitising cat.1 according to Annex VI of CLP (1272/2008/EC).

Justification for selection of respiratory sensitisation endpoint:
There is no available information on animals. Several occupational sensitization cases by inhalation at processing sites were reported. Tetrahydromethylphthalic anhydride (MTHPA) is classified due to human case report and due to its chemical structure skin sensitising cat.1 and respriatory sensitising cat.1 according to Annex VI of 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. Tetrahydromethylphthalic anhydride (MTHPA) is classified due to human case report and due to its chemical structure skin sensitising cat.1 and respriatory sensitising cat.1 according the harmonised classification Annex VI of CLP (1272/2008/EC) and Xn, R42/43 (May cause sensitisation by inhalation and skin contact) according to 67/548/EEC.