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EC number: 220-051-4 | CAS number: 2618-96-4
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- three-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from OECD SIDS
Data source
Reference
- Reference Type:
- secondary source
- Title:
- SIDS Initial Assessment Profile of ε-caprolactam
- Author:
- OECD SIDS
- Year:
- 2 001
- Bibliographic source:
- OECD SIDS, 26 November 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Three-generation reproductive toxicity study of ε-caprolactam in Rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- ε-caprolactam
- Cas Number:
- 105-60-2
- Molecular formula:
- C6H11NO
- IUPAC Name:
- ε-caprolactam
- Details on test material:
- - Name of test material (as cited in study report): ε-caprolactam
- Molecular formula (if other than submission substance): C6H11NO
- Molecular weight (if other than submission substance): 113.1589 g/mole
- Substance type: Organic
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): ε-caprolactam
- Molecular formula (if other than submission substance): C6H11NO
- Molecular weight (if other than submission substance): 113.1589 g/mole
- Substance type: Organic
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Remarks on MMAD:
- not specified
- Vehicle:
- not specified
- Details on exposure:
- not specified
- Details on mating procedure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- More than 90 days.
- Frequency of treatment:
- Daily
- Details on study schedule:
- through three successive generations
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 83 mg/kg bw/day
- Remarks:
- ca.
- Dose / conc.:
- 417 mg/kg bw/day
- Remarks:
- ca.
- Dose / conc.:
- 833 mg/kg bw/day
- Remarks:
- ca.
- No. of animals per sex per dose:
- Not specified
- Control animals:
- not specified
- Details on study design:
- Not specified
- Positive control:
- Not specified
Examinations
- Parental animals: Observations and examinations:
- Clinical signs were observed
- Oestrous cyclicity (parental animals):
- Not specified
- Sperm parameters (parental animals):
- Not specified
- Litter observations:
- Gross appearance, survival, body weight, food consumption, number of pups and percentage of male pups were examined.
- Postmortem examinations (parental animals):
- Histopathology was examined.
- Postmortem examinations (offspring):
- Gross pathology and histopathology was examined.
- Statistics:
- Not specified
- Reproductive indices:
- Reproductive performance was examined.
- Offspring viability indices:
- Not specified
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical signs were observed in treated rats
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Slight increase in the severity of spontaneous nephropathies occasionally accompanied by granular casts were observed in 833 mg/kg bw treated rats.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 833 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- reproductive performance
- Remarks on result:
- other: No effect on reproductive organs or function
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No effect on gross appearance of treated rat were observed.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No effect on survival of rat were observed.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 833 mg/kg bw, decrease in body weight were observed in rats
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 833 mg/kg bw, decrease in food consumption were observed in rat
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No effect on kidney weight of offspring was observed.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No effect on gross pathology of offspring was observed as compared to control.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 833 mg/kg bw, slight increase in the severity of nephropathy accompanied by the presence of granular casts in some rats were observed.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No effect on number of pups and percentage of male pups were observed in treated rats.
Effect levels (P1)
- Dose descriptor:
- NOAEL
- Effect level:
- 833 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- organ weights and organ / body weight ratios
- gross pathology
- reproductive performance
- Remarks on result:
- other: no adverse effect on reproductive organs or function
Target system / organ toxicity (P1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No effect on gross appearance of treated offspring were observed.
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No effect on survival of offspring were observed.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 833 mg/kg bw, decrease in body weight were observed in offspring.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 833 mg/kg bw, decrease in food consumption were observed in offspring.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No effect on kidney weight of offspring was observed.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No effect on gross pathology of offspring was observed as compared to control.
- Histopathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 833 mg/kg bw, slight increase in the severity of nephropathy accompanied by the presence of granular casts in some offspring were observed.
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 833 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- organ weights and organ / body weight ratios
- gross pathology
- Remarks on result:
- other: no adverse effect on reproductive organs or function
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No effect on gross appearance of treated offspring were observed.
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No effect on survival of offspring were observed.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 833 mg/kg bw, decrease in body weight were observed in offspring.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- When treated with 833 mg/kg bw, decrease in food consumption were observed in offspring.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No effect on kidney weight of offspring was observed.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No effect on gross pathology of offspring was observed as compared to control.
- Histopathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 833 mg/kg bw, slight increase in the severity of nephropathy accompanied by the presence of granular casts in some offspring were observed.
- Other effects:
- no effects observed
- Description (incidence and severity):
- No adverse effect on reproductive organs or function were observed in treated rats.
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 833 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- organ weights and organ / body weight ratios
- gross pathology
- other: Reproduction
- Remarks on result:
- other: no adverse effect on reproductive organs or function
Target system / organ toxicity (F2)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 833 mg/kg bw for P, F1 and F2 generation when F344 male and female rats were treated with ε-caprolactam orally in feed through three successive generations.
- Executive summary:
In a three-generation reproductive toxicity study, F344 male and female rats treated with ε-caprolactam in the concentration of 0, 83, 417, 833 mg/kg bw orally in feed through three successive generations. No clinical signs were observed in treated P rats. No effect on number of pups and percentage of male pups were observed in treated P rats. Slight increase in the severity of spontaneous nephropathies occasionally accompanied by granular casts was observed in 833 mg/kg bw treated P rats. Similarly, No effect on survival, gross appearance, number of pups, percentage of male pups and kidney weight were observed in F1, F2 and F3 offspring. Decrease in body weight and food consumption was observed in F1, F2 and F3 offspring. In addition, slight increase in the severity of nephropathy accompanied by the presence of granular casts in some offspring were observed but no adverse effect on reproductive organs or function was observed in P, F1 and F2 generation. Therefore, NOAEL was considered to be 833 mg/kg bw for P, F1 and F2 generation when F344 male and female rats were treated with ε-caprolactam orally in feed through three successive generations.
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