Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Standard test method used (OECD test guidelne) GLP statement
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 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
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: 97.70%
- 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:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Manston, Kent, England
- Age at study initiation: 6-9 weeks
- Weight at study initiation:
- Fasting period before study: Overnight
- Housing: 5/sex/cage
- Diet (e.g. ad libitum): Conventional laboratory diet (Rat and Mouse No. 1 expanded; Special Diet Services Limited) fed ad libitum except for overnight fast before dosing and approximately 2 hours following dosing
- Water (e.g. ad libitum): Municipal mains water available ad libitum
- Acclimation period: Minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 34-84
- Air changes (per hr): Approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1991-01-15 To: 1991-02-28
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5 males / 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations 30 minutes, 1, 2 and 4 hours after dosing then daily for 14 days. Body weights recorded on day of dosing (Day 0) and at weekly intervals during post-dose observation period (Days 7 and 14)
- Necropsy of survivors performed: yes - Statistics:
- None
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- One of 5 males and 1 of 5 females died within 24 hours of dosing (See Table 1 for details)
- Clinical signs:
- other: Lethargy, hunched posure, ataxia, ptosis, laboured respiration and loss of righting reflex noted following dosing. Surviving animals had generally recovered within 24 hours of dosing (See Table 1 for details)
- Gross pathology:
- No abnormal findings in surviving animals
Animals that died showed changes to the lungs, liver and kidneys that were possibly agonal in nature.
Haemorrhaging noted in regions of the stomach, small and large intestines noted (See Table 2 for details)
Any other information on results incl. tables
Table 1: Clinical findings / mortality
|
|||||||||
Dose |
Animal |
Clinical signs / Mortality |
|||||||
level |
Sex |
number |
Hours |
Days |
|||||
(mg/kg) |
|
|
0.5 |
1 |
2 |
4 |
|
1 |
2-14 |
5-0 |
0 |
0 |
HLPtA |
HLPtRlA |
X |
- |
|||
5-1 |
0 |
0 |
L |
L |
0 |
0 |
|||
Male |
5-2 |
0 |
0 |
L |
L |
0 |
0 |
||
5-3 |
0 |
0 |
L |
L |
0 |
0 |
|||
5-4 |
0 |
0 |
L |
L |
0 |
0 |
|||
5000 |
|||||||||
6-0 |
0 |
0 |
LPt |
HLPt |
H |
0 |
|||
6-1 |
0 |
0 |
HL |
HLPt |
0 |
0 |
|||
Female |
6-2 |
0 |
0 |
L |
0 |
0 |
0 |
||
6-3 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
|
|
6-4 |
LA |
LPtRr |
X |
- |
|
- |
- |
Key: |
0 : No signs of toxicity |
||||||||
H : Hunched posture |
|||||||||
L : Lethargy |
|||||||||
A : Ataxia |
|||||||||
Pt : Ptosis |
|||||||||
Rl : Laboured respiration |
|||||||||
Rr : Loss of righting reflex |
|||||||||
X : Animal dead |
Table 2: Necropsy findings
|
||||
Dose level |
Sex |
Animal |
Day of death |
Macroscopic observations at necropsy |
(mg/kg) |
_ |
_ |
_ |
_ |
5-0 |
Died Day 1 |
Lungs: haemorrhagic |
||
Liver: dark |
||||
Kidneys: dark |
||||
Stomach: epithelial sloughing from glandular and non-glandular regions |
||||
Small intestine: haemorrhagic |
||||
Large intestine: haemorrhagic |
||||
5-1 |
Terminal kill |
No abnormalities noted |
||
Male |
5-2 |
Terminal kill |
No abnormalities noted |
|
5-3 |
Terminal kill |
No abnormalities noted |
||
5-4 |
Terminal kill |
No abnormalities noted |
||
5000 |
||||
6-0 |
Terminal kill |
No abnormalities noted |
||
6-1 |
Terminal kill |
No abnormalities noted |
||
Female |
6-2 |
Terminal kill |
No abnormalities noted |
|
6-3 |
Terminal kill |
No abnormalities noted |
||
6-4 |
Died Day 0 |
Lungs: abnormally red |
||
Liver: dark |
||||
Stomach: glandular region haemorrhagic |
||||
|
|
|
|
Small intestine: haemorrhagic |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.