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Diss Factsheets
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EC number: 228-001-3 | CAS number: 6066-82-6
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1971
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- - Principle of test: Test the teratogenic effects of the substance.
- Short description of test conditions: Rats were given the test item for 4 weeks, one week after the beginning of the treatment the breeding started.
- Parameters analysed / observed: Number of births and malformations of the fetuses. - GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- N-hydroxysuccinimide
- EC Number:
- 228-001-3
- EC Name:
- N-hydroxysuccinimide
- Cas Number:
- 6066-82-6
- Molecular formula:
- C4H5NO3
- IUPAC Name:
- 1-hydroxypyrrolidine-2,5-dione
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: 3-4 months
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data
Administration / exposure
- Route of administration:
- other: Drinking water (oral) and subcutaneous
- Vehicle:
- physiological saline
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- Treatment in the drinking water daily. Twice a week injection.
Doses / concentrations
- Dose / conc.:
- 125 mg/kg bw/day (nominal)
- Remarks:
- On injection days the dose was 225 mg/kg/day (nominal)
- No. of animals per sex per dose:
- 8 female rats
- Control animals:
- yes, concurrent no treatment
Examinations
- Maternal examinations:
- Number of births in control and treated groups.
- Fetal examinations:
- Any visible defects in the fetuses.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- not specified
- Other effects:
- not specified
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 125 mg/kg bw/day (nominal)
- Based on:
- test mat.
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- No significant differences between number of births in the treated group compared to the control group (control: average 10-12 fetuses/female, treated: average 11 fetuses/female).
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Description (incidence and severity):
- No visible birth defects were observed in the fetuses.
- Skeletal malformations:
- not examined
- Visceral malformations:
- not examined
- Other effects:
- not examined
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 125 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- external malformations
Applicant's summary and conclusion
- Conclusions:
- The test item seems to have a NOAEL higher than 125 mg/kg bw/day (maximal dose 225 mg/kg on injection days) in rats, based on the number of births and birth defects. However, no conclusion can be drawn due to the insufficient data.
- Executive summary:
A study was conducted to assess the teratogenic potential of the test item in rats. Eight Sprague-Dawley rats were treated for four weeks with an aqueous solution of the test item by injection (twice a week) and in drinking water (daily). The injected dose was about 100 mg/kg and the dose in drinking water was about 125 mg/kg, then the days of injection the total dose was 225 mg/kg. The breeding started one week after starting the treatment. No significant differences between the number of births in the treated group compared to the control group (control: average 10-12 fetuses/female, treated: average 11 fetuses/female). No visible birth defects were observed in the fetuses. Under these experimental conditions, the test item seems to have a NOAEL higher than 125 mg/kg bw/day (maximal dose 225 mg/kg on injection days) in rats, based on the number of births and birth defects. However, no conclusion can be drawn due to the insufficient data.
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