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EC number: 255-180-5 | CAS number: 41026-17-9
- 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
1,2,3,6-tetrahydrophthalic anhydride, oligomeric reaction products with 2,2-dimethylpropan-1,3-diol used as read-across chemical was tested for acute toxicity in an OECD 425 acute oral toxicity in rats and in a OECD 422 acute dermal toxicity in rats.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Please refer to the Read-Across justification document englosed in chapter 13 for more details.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Female rats were acquired from Texas Animal Specialties; Humble, TX and were Day-i Wt/Day 0 (fasted) Wt: 180-205 gm / 162-187 gm. The animals were housed one/cage in suspended stainless steel with wire bottom. The Actual Temp/Relative Humidity during the study was 19-22°C /30-91% respectively. There was a 12-hour light/dark cycle and 10-12 air changes/hour in the animal rooms. PMI Feeds Inc.Formulab #5008; was available ad libitum except for approximately 16 hours before dosing. Municipal water supply analyzed by TCEQ Water Utilities Division; was also
available ad libitum from automatic water system.
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test substance was administered as received and was not diluted. An individual dose was calculated for each animal based on its fasted body weight and administered by gavage at a volume of 1.67 mL/kg. Each dose was administered using an appropriately sized syringe and stainless steel ball-tipped intubation needle. The animals were returned to their cages immediately after dosing.
- Doses:
- 2000 mg/kg of body weight Limit Dose.
- No. of animals per sex per dose:
- Five
- Control animals:
- no
- Details on study design:
- Following dosing observations for mortality and clinicall behavioral signs of toxicity were made at least three times on the day of dosing (Day 0) and at least once daily thereafter for 14 days. Individual body weights were recorded just prior to dosing and on Days 7 and 14. On Day 14 after dosing, each animal was euthanized by an overdose of CO2. All study animals were subjected to gross necropsy and all abnormalities were recorded.
- Statistics:
- None required.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- There were no observable abnormalities.
- Interpretation of results:
- relatively harmless
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The rat acute oral LD50 for the test substance was determined to be > 2000 mg/kg of body weight.
- Executive summary:
The test substance, 1,2,3,6 -Tetrahydrophthalic anhydride, oligomeric reaction products with 2,2 -dimethylpropane-1,3 -diol was evaluated for acute oral toxicity in an O.E.C.D. test guideline 425 study. No mortalities occured during the study. Therefore the rat acute oral LD50 is > 2000 mg/kg of body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Please refer to the Read-Across justification document englosed in chapter 13 for more details.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals were acquired from Texas Animal Specialties; Humble, TX and weighted on the dosing Day: Male: 244-264 gm; Female: 176-185 gm The animals were housed in suspended stainless steel with wire bottom cages 1 per cage. The animal room was maintained at actual Tempt/Relative Humidity of 20-22°C /34-91% with 12-hour light/dark cycle and 10-12 air changes/hour. PMI Feeds Inc.TM Formulab #5008 was available ad libitum and
Municipal water supply (Sugar Land, TX) analyzed by TCEQ Water Utilities Division; tap water, was also available ad libitum (automatic system) - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The animals were prepared on the day prior to treatment by clipping the dorsal surface of the trunk free of hair to expose not less than 10% of the total body surface area. The test substance was applied evenly to each exposure area in a thin, uniform layer. The area of application was covered with a 2 x 4 in. surgical gauze patch and secured with non-irritating adhesive tape. The trunk of each animal was then wrapped with a veterinary flexible cohesive bandage, secured in place with non-irritating adhesive tape to prevent possible ingestion of the test substance,
- Duration of exposure:
- 24 hr
- Doses:
- approximately 2000 mg/kg of body weight.
- No. of animals per sex per dose:
- Five
- Control animals:
- no
- Details on study design:
- After 24 hour exposure period, the dermal wrappings were removed. The test sites were gently washed with room temperature tap water and a clean cloth to remove as much residual test substance as possible. Observations for mortality and clinical/behavioral signs of toxicity were made at least three times on the day of dosing (Day 0) and at least once daily thereafter for 14 days. Individual body weights were recorded just prior to dosing and on Days 7 and 14 Observations for evidence of derinal irritation were made at approximately 60 minutes after removal of the dermal wrappings, and on Days 4, 7, 11 and 14. On Day 14 after dosing, animals were euthanized by an overdose of CO2. All study animals were subjected to gross necropsy and all abnormalities were recorded.
- Statistics:
- None required.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- There were no observable abnormalities.
- Other findings:
- There was no evidence of dermal irritation following the 24 hr exposure.
- Interpretation of results:
- relatively harmless
- Remarks:
- Migrated information and not irritating. Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test substance has a an acute dermal LD50 of > 2000 mg/kg of body weight in the rat. Furthermore, the test substance was not irritating to the skin under the conditions of the study.
- Executive summary:
The test substance, 1,2,3,6 -Tetrahydrophthalic anhydride, oligomeric reaction products with 2,2 -dimethylpropane-1,3 -diol, was evaluated in an O.E.C.D. 402 rat acute dermal toxicity study. The acute dermal LD50 was > 2000 mg/kg of body weight. Furthermore, the test substance was not irritating to the skin under the conditions of the study with a 24 hr exposure period. .
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
The acute dermal and oral LD50 values for 1,2,3,6-tetrahydrophthalic anhydride, oligomeric reaction products with 2,2-dimethylpropan-1,3-diol used as read-across chemical was greater than 2000 mg/kg body weight. Furthermore, no evidence of dermal irritation was noted during the acute dermal toxicity study.
Justification for classification or non-classification
- oral toxicity:
Based on the above stated assessment of the acute oral toxicity (absence of toxicity up to 2000 mg/kg) the substance does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and accordingCLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council)as implementation of UN-GHS in the EU.
- dermal toxicity:
Based on the above stated assessment of the acute dermal toxicity (absence of toxicity up to 2000 mg/kg) the substance does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and accordingCLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council)as implementation of UN-GHS in the EU.
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