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Diss Factsheets
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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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): P2008
- Analytical purity: 97.7%
- Impurities (identity and concentrations): Tetrahydrophthalic anhydride D3 - 0.02%; Tetrahydrophthalic anhydride D4 - 0.05%;
Tetrahydrophthalimide D3 - 1.48%; Tetrahydrophthalimide D4 isomer - 0.75%
- Lot/batch No.: 1801
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Limited, Moston, Sandbach, Cheshire, England
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.46 - 2.80 kg
- Housing: Individually housed in metal cages
- Diet (e.g. ad libitum): Conventional labroatory diet (Spillers Rabbit Diet, Dalgety Agriculture Limited, Bristol, England) available ad libitum
- Water (e.g. ad libitum): Municipal supply drinking water available ad libitum
- Acclimation period: Minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 49 - 61
- Air changes (per hr): Approximately 15
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
IN-LIFE DATES: From: 1991-01-09 To: 1991-01-12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Clipped free of fur
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: Gauze patch secured in place with "Blenderm" surgical adhesive tape. Overlaid by "Tubigrip" elasticated bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual material removed by swabbing skin with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scale (See Table 1)
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- <= 0.1
- Max. score:
- 8
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Slight erythema observed in 2 of 3 animals 1 hour after the 4 hour dosing period.
Reaction remained in 1 animal at 24 hours.
Complete recovery occurred within 48 hours
Method of calculating maximum irritation score: Maximum score for erythema (4) + maximum score for oedema (4) at each of the 3 time points (24, 48 and 72 hour examinations) and each animal divided by number of animals (3) and number of examinations (3)
Any other information on results incl. tables
Table 2: Irritation: Individual findings |
|||
Animal number |
Time of examination |
Erythema |
Oedema |
1 Hour |
1 |
0 |
|
15 |
24 Hours |
1 |
0 |
48 Hours |
0 |
0 |
|
_ |
72 Hours |
0 |
0 |
1 Hour |
1 |
0 |
|
36 |
24 Hours |
0 |
0 |
48 Hours |
0 |
0 |
|
_ |
72 Hours |
0 |
0 |
1 Hour |
0 |
0 |
|
67 |
24 Hours |
0 |
0 |
48 Hours |
0 |
0 |
|
_ |
72 Hours |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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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