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EC number: 201-603-3 | CAS number: 85-41-6
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
- Reference Type:
- secondary source
- Title:
- Phthalimide - CAS No: 85-41-6
- Author:
- OECD SIDS
- Year:
- 2 005
- Bibliographic source:
- SIDS Initial Assessment Report for 20th SIAM, UNEP Publications
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phthalimide
- EC Number:
- 201-603-3
- EC Name:
- Phthalimide
- Cas Number:
- 85-41-6
- Molecular formula:
- C8H5NO2
- IUPAC Name:
- 1H-isoindole-1,3(2H)-dione
- Details on test material:
- - Name of test material (as cited in study report): phthalimide
- Analytical purity: > 99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 weeks old (male and female rats)
- Weight at study initiation: 350-402 g for male, 195-257 g for female
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Carboxymethylcellulose sodium 1%
- Duration of treatment / exposure:
- Males, 46 days
Females, from 14 days before mating to day 3 of lactation (at least 38 days) - Frequency of treatment:
- Once a day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 250, 500, 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: none
Examinations
- Observations and examinations performed and frequency:
- CLINICAL OBSERVATIONS AND FREQUENCY
Clinical signs and mortality: every day
BODY WEIGHT: Yes
Body weight: male: day 1, 2, 5, 7, 10, 14, 21, 28, 35, 42, 46; female: before mating day 1, 2, 5, 7, 10, 14; during gestation: day 0, 1, 3, 5, 7, 10, 14, 17, 20; after parturition: day 0, 1, 4
FOOD CONSUMPTION
Food consumption: at every body weight check (24h consumption), except day 0 of gestation and day 0 of parturition for female water
consumption: not checked
URINALYSIS: Yes
Urinalysis: performed in all males at day 43-44; pH, protein, sugar, ketones, urobilinogen, bilirubin, occult blood, specific gravity, deposit and appearance
HAEMATOLOGY: Yes
Hematology: performed in all males at day 46; erythrocyte count, MCV, platelet count, leukocyte count, hemoglobin, hematocrit, MCH, mean corpuscular hemoglobin (MCHC), differential leukocyte count, PT (prothrombin time) and ATPP (activated partial thromboplastin time)
CLINICAL CHEMISTRY: Yes
Blood biochemical: Same sample as hematology was used; total protein, albumin, albumin/globulin (A/G) ratio, GOT, GPT, alkaline phosphatase (ALP), lactate dehydrogenase (LDH), cholin esterase (Ch-E), gamma-GTP, total bilirubin, glucose, total cholesterol, triglyceride, phospholipids, urea nitrogen, creatinine, sodium, potassium, chlorine, calcium and inorganic phosphorus
NEUROBEHAVIOURAL EXAMINATION: No
OPHTHALMOSCOPIC EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes: brain, lung, heart, liver, kidneys, spleen, adrenal, pituitary gland, thymus, thyroids, testis, epididymides and ovaries, number of implants and corpora lutea
HISTOPATHOLOGY: Yes : lung, cecum, liver, kidney, testis, epididymis, prostate, spleen, mediastinal lymph node, renal lymph node, lumbar lymph node, pituitary gland, adrenal and skin
Results and discussion
Results of examinations
- Details on results:
- Males:
No effects of phthalimide were detected on general appearance, body weight, food consumption, organ weights, autopsy, gross pathology, urinalysis, hematological or biochemical parameters, or histopathological findings in males.
Females:
Histopathological examination revealed periportal fatty change in the liver, renal epithelial fatty change, and atrophy in the thymus in one female given 1000 mg/kg. No effects of phthalimide were detected on general appearance, body weight, food consumption, organ weights, autopsy gross pathology of females, or by histopathological examination of the other females.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- histopathology: non-neoplastic
- Remarks on result:
- other: In one female given 1000 mg/kg bw/day body weight and food consumption were decreased, and histopathological examination revealed periportal fatty change in the liver, renal epithelial fatty change, and atrophy in the thymus
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- gross pathology
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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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