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EC number: 201-602-8 | CAS number: 85-40-5
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well conducted GLP compliant study to recognised internaional test methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1,2,3,6-tetrahydrophthalimide
- EC Number:
- 201-602-8
- EC Name:
- 1,2,3,6-tetrahydrophthalimide
- Cas Number:
- 85-40-5
- Molecular formula:
- C8H9NO2
- IUPAC Name:
- 2,3,3a,4,7,7a-hexahydro-1H-isoindole-1,3-dione
- Details on test material:
- - Name of test material (as cited in study report): THPI D4 (1,2,3,6 tetra-hydro-phthalimide)
- Physical state: Solid
- Analytical purity: 98.26%
- Lot/batch No.: STI4209019
- Expiration date of the lot/batch: 2010-01-19
- Storage condition of test material: Room temperature, protectd from light and humidity
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories BV
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 19 - 22 g
- Housing:Group caged in Makrolon Type II cages
- Diet (e.g. ad libitum): Harlan pelleted standard 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 (%): 45 - 65%
- Air changes (per hr): Not stated
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
IN-LIFE DATES: From: 2009-03-10 To: 2009-04-01
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 5, 10 and 25%
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Up to 25% in dimethylformamide
- Irritation: None observed following 3 consecutive days application at 10 and 25% concentration
- Lymph node proliferation response: Not assessed
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
Random allocation to 4 treatment groups to give a total of 4 groups, each of 5 animals
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: Minimum of a 3 fold increase in Stimulatioin Index relative to controls
TREATMENT PREPARATION AND ADMINISTRATION:
The test substance was dissolved in dimethylformamide at the highest achieveable concentration of 25%. Lower concentrations of 10 and 5% were prepared by serial dilution.
Animals of each test group treated by topical application to the dorsal surface of both ears once daily for 3 consecutive days. A volume of 25 μL applied on each occasion. Control animals treated with the vehicle alone.
Five days following the first topical application all animals were treated by intravenous injection of 250 μL 3H-methyl thymidine (activity 19.9 μCi / animal). Five hours later animals were killed and draining lymph modes removed and pooled per animal. Cell suspensions were prepared, incubated to precipitate macromolecules. The precipitates were re-suspended in 5% trichloroacetic acid, mixed with a scintillation liquid and the level of radiolabelled thymidine incorporation determined by β-scintillation counting, recorded as the number of radioactive disintegrations / minute (DPM). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- ANOVA (Dunnett test) undertaken to examine differences between treatment and control groups
Results and discussion
- Positive control results:
- EC3 value (estimated concentration to give a Stimulation Index of 3) = 7.8% of α-cinnamicaldehyde
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Vehicle control - 1.00 5% test substance - 1.00 10% test substance - 0.78 25% test substance - 1.07
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Vehicle control - 457.6 5% test substance - 456.4 10% test substance - 358.9 25% test substance - 490.8 Cited values represent the sum of measured values from all lymph nodes within a group divided by the number of lymph nodes assayed frpom the group
Any other information on results incl. tables
All treated animals survived the study period and no signs of toxicity were observed.
Stimulation indices of 1.00, 0.78 and 1.07 were determined with the test substance at concentrations of 5, 10 and 25%.
The EC3 value could not be determined as no tested concentration gave a Stimulation Index greater than 3
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test substance is not a skin sensitiser under the conditions of the Local Lymph Node Assay
- Executive summary:
The test substance is not a skin sensitiser under the conditions of the Local Lymph Node Assay
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