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EC number: 226-247-6 | CAS number: 5333-84-6
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1993-08-04 to 1993-08-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 84/449/EEC
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Tetrahydromethylphthalic anhydride
- EC Number:
- 234-290-7
- EC Name:
- Tetrahydromethylphthalic anhydride
- Cas Number:
- 11070-44-3
- IUPAC Name:
- 3a-methyl-3a,4,5,6-tetrahydro-2-benzofuran-1,3-dione
- Details on test material:
- - Name of test material (as cited in study report): P0314 (Methyltertrahydrophtalic anhydride/NT)
- Physical state: colourless slightly viscous liquid
- Analytical purity: 99.9 %
- Lot/batch No.: 93/307
- Storage condition of test material: room temperature in clear glass jar
- Molecular formula (if other than submission substance): C9 H10 O3
- Molecular weight (if other than submission substance): 166.18
- Smiles notation (if other than submission substance): O=C(OC(=O)C1CC=C(C2)C)C12
- InChl (if other than submission substance): 1/C9H10O3/c1-5-2-3-6-7(4-5)9(11)12-8(6)10/h2,6-7H,3-4H2,1H3
- Structural formula attached as image file (if other than submission substance): see Fig. (11070-44-3 structure.jpg)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, U.K.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 10 - 14 weeks
- Weight at study initiation: males - 234-255 g; females - 207-237 g
- Fasting period before study: n/a
- Housing: Individually during the 24-hour exposure period and in groups of up to five, by sex, for the remainder of the study.
- Diet: R&M No. 1, Special Diet Services Limited, Witham, Essex, U.K., ad libitum
- Water: Municipal supply, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22°C
- Humidity (%): 50-56%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1993-08-04 To: 1993-08-18
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: ca. 5 x 4 cm
- % coverage: ca. 10%
- Type of wrap if used: semi-occluded
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes - distilled water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied: 1.68 mL/kg bodyweight giving a dose level of 2000 mg/kg body weight
- Constant concentration used: yes - undiluted
- For solids, paste formed: yes/no - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw (1.68 mL/kg bw)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Examined for any dermal reactions after removal of the dressings and subsequently once daily for the remainder of the study. Bodyweight recorded Days 0, 7 and 14.
- Necropsy of survivors performed: yes
Results and discussion
- Preliminary study:
- no preliminary study
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the study. Dermal Reactions: Very slight to well-defined erythema was noted at the treatment sites of all animals one day after dosing with very slight erythema in all females two days after dosing. Haemorr
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test material, tetrahydromethylphthalic anhydride, in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bw.
- Executive summary:
The study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 402 "Acute Dermal Toxicity" referenced as Method B.3 in Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
A group of ten animals (five males and five females) was given a single 24-hour, semi-occluded dermal application to intact skin at a dose level of 2000 mg/kg bw. The animals were observed for fourteen days after the day of treatment and were then killed for gross pathological examination.
There were no deaths. No signs of systemic toxicity were noted during the study. Very slight to well-defined erythema was noted at the
treatment sites of all animals. Other skin reactions noted were haemorrhage of the dermal capillaries and crust formation. Treatment sites appeared normal two to five days after dosing. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy.
The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight.
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