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Diss Factsheets
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EC number: 247-570-9 | CAS number: 26266-63-7
- 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
Acute toxicity:
Oral - LD50: <2000 mg/kg
Dermal - LD50: > 2000 mg/kg
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material: Sample from production lot
- Lot/batch No.of test material: Lab sample of October 9th 2015
- Expiration date of the lot/batch: 2016-10-08
- Purity: 99.91%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient conditions
- Stability under test conditions: Stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS srl, San Pietro al Natisone, Italy
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 7 - 9 weeks
- Weight at study initiation: 168 - 233 g
- Fasting period before study: Overnight prior to dosing and for approximately 4 hours following dosing
- Housing:Group caged in solid bottomed cages
- Diet (e.g. ad libitum): Commerical rodent diet, ad libitum
- Water (e.g. ad libitum): Municipal supply drinking water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 deg C
- Humidity (%): 40 - 70%
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 2016-09-21 To: 2016-11-04 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30, 200 and 500 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION (if unusual): Test substance dissolved/suspended in vehicle on a w/v basis
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As specified by test guidelines - Doses:
- 5000 mg/kg
2000 mg/kg
300 mg/kg - No. of animals per sex per dose:
- 1 at 5000 mg/kg
3 at 2000 mg/kg
6 at 300 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations - at least daily; Weighing - weekly
- Necropsy of survivors performed: Yes - Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 5000 mg/kg - 100% (1/1)
2000 mg/kg - 67% (2/3)
300 mg/kg - 0% (0/6) - Clinical signs:
- other: 5000 mg/kg - Piloerection and hunched posture 2000 mg/kg - Piloerection, hunched posture, reduced activity and part-closed eyes 300 mg/kg - No clinical signs of treatment
- Gross pathology:
- No abnormalities noted
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute toxicity of tetrahydrophthalic anhydride (tTHPA) has been investigated following a single oral administration to the rat.
Mortality was observed in animals following dosing at 5000 and 2000mg/kg. No mortality occurred and no signs of toxicity were observed following dosing at 300mg/kg. - Executive summary:
The acute toxicity of tetrahydrophthalic anhydride (tTHPA) has been investigated following a single oral administration to the rat.
Mortality was observed in animals following dosing at 5000 and 2000mg/kg. No mortality occurred and no signs of toxicity were observed following dosing at 300mg/kg.
Based on these findings the substance should be classified in Category 4 according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 300 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Acute oral toxicity has been investigated using methods as described or similar to those of OECD/EU test guidelines. The LD50 following administration of a single oral dose to rats was approximately 3200 mg/kg body weight. A value of 5410 mg/kg body weight is reported, in a peer reviewed handbook. A more recent study suggests greater toxicity to the substance, the indicated LD50 being below 2000 mg/kg body weight.
Acute dermal toxicity has been investigated in accordance with OECD/EU test methods. A single dose of 2000 mg/kg was administered to a group of 5 male and 5 female animals for 24 hours. No toxicity occurred and the lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.
Justification for classification or non-classification
Findings from oral administration studies are not consistent. Two studies suggest no classification to be necessary while one study indicates classification in Category 4 - Harmful if swallowed (H302) to be relevant.
The lack of observed toxicity in acute single exposure studies by the dermal route does not indicate classification as being necessary.
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.
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