Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 234-290-7 | CAS number: 11070-44-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
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).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Link to relevant study records
- Endpoint:
- respiratory sensitisation: in vivo
- 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
- 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).
Reference
no details given
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 µg/m3 as a limit for exposure to MTHPA during an 8 hr work shift. The cause of this value was respiratory sensitisation.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
There is no available experimental test data in animals suitable for classification purposes under Regulation (EC) No 1272/2008.
However, several occupational sensitization cases by inhalation at processing sites were reported. Therefore, Tetrahydromethylphthalic anhydride (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 the harmonised classification Annex VI of CLP (1272/2008/EC), as amended for the eighteenth time in Regulation (EU) 2022/692.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.