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EC number: 218-336-3 | CAS number: 2123-24-2
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- no information on the analytical examination of doses, ophthalmoscopic and neurobehavioural examination not performed
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- ε-caprolactam
- EC Number:
- 203-313-2
- EC Name:
- ε-caprolactam
- Cas Number:
- 105-60-2
- Molecular formula:
- C6H11NO
- IUPAC Name:
- azepan-2-one
- Details on test material:
- - Name of test material (as cited in study report): Caprolactam
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: Broekman Institute, Stiphout, The Netherlands
- Mean weight at study initiation: male 42.6 g, female 41.2 g
- Housing: 5 per cage
- Diet (e.g. ad libitum): test compound was thoroughly mixed into the stock diet
- Water (e.g. ad libitum): tap water
Administration / exposure
- Route of administration:
- oral: feed
- Details on oral exposure:
- DIET PREPARATION
- The following percentage composition of stock diet was used: yellow maize 29.5, brewer's yeast 3, whole wheat 36, grass meal 3, soyabean-oil meal 10, soyabean oil 3, meat scraps 4, vitamin preparations 0.5, fish meal 8, trace mineralized salt 0.5, dried whey 2, and calcium phosphate 0.5. The test compound was thoroughly mixed into the stock diet by means of a modified meat cutter (Stefan).
- Rate of preparation of diet (frequency): The diets were freshly prepared once a fortnight - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- continuously
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.05 other: % (nominal in diet)
- Dose / conc.:
- 0.1 other: % (nominal in diet)
- Dose / conc.:
- 0.25 other: % (nominal in diet)
- Dose / conc.:
- 0.5 other: % (nominal in diet)
- Dose / conc.:
- 1 other: % (nominal in diet)
- Dose / conc.:
- 29 mg/kg bw/day (actual dose received)
- Remarks:
- males
- Dose / conc.:
- 60 mg/kg bw/day (actual dose received)
- Remarks:
- males
- Dose / conc.:
- 146 mg/kg bw/day (actual dose received)
- Remarks:
- males
- Dose / conc.:
- 296 mg/kg bw/day (actual dose received)
- Remarks:
- males
- Dose / conc.:
- 592 mg/kg bw/day (actual dose received)
- Remarks:
- males
- Dose / conc.:
- 35 mg/kg bw/day (actual dose received)
- Remarks:
- females
- Dose / conc.:
- 70 mg/kg bw/day (actual dose received)
- Remarks:
- females
- Dose / conc.:
- 170 mg/kg bw/day (actual dose received)
- Remarks:
- females
- Dose / conc.:
- 342 mg/kg bw/day (actual dose received)
- Remarks:
- females
- Dose / conc.:
- 704 mg/kg bw/day (actual dose received)
- Remarks:
- females
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: The toxicity of caprolactam (CAP) was examined in a range-finding test with weanling albino rats fed the test substance at dietary levels of 0, 0.2, 1 and 5 % for 28 days. CAP at levels of 5 % and 1 % in the diet caused growth depression and increased liver and kidney weights. Histopathological changes in liver and kidney were observed in the 5 % group in both sexes. In the 1 % group slight histopathological changes were observed only in the kidneys of males. On the basis of the present results 1% CAP is expected to be an effect level in a sub-chronic (90-day) toxicity study.
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 13 week
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: all
- Parameters checked: haemoglobin, packed cell volume, red blood cell counts and total and differential white blood cell counts
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at the end of experiment
- Animals fasted: No data
- How many animals: all
- Parameters checked: glutamic-pyruvic transaminase (SGPT), glutamic-oxalacetic transaminase (SGOT), alkaline phosphatase (SAP), total serum
protein, albumin and albumin-globulin ratio
URINALYSIS: Yes
- Time schedule for collection of urine: 13 week
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked: appearance, pH, glucose, albumin, occult blood, ketones and microscopy of the sediment - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- The following organs were weighed: heart, kidneys, spleen, liver, brain, testicles/ovaries, thymus, pituitary, thyroids and adrenals
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- During the course of the experiment no abnormalities of condition or behaviour were observed.
- Mortality:
- no mortality observed
- Description (incidence):
- During the course of the experiment no deaths occurred.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Slight growth depression occurred at the 1.0 % feeding level in both sexes. This growth depession was only biologically relevant in males (15 and 11% at week 2 and 4).
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- Decreased food consumption was observed at the highest feeding level in both sexes during week 2, 3 and 4. At 0.5 % food consumption was relatively low in week 2 and 3 in both sexes. Towards the end of the experiment food consumption was comparable in all groups.
- Food efficiency:
- effects observed, treatment-related
- Description (incidence and severity):
- Food efficiency in males at the highest feeding level was slightly lower than in the other test groups. The food efficiency figure obtained in control males was low, probably as a result of relatively low body weights at week 4 which had disappeared not until week 10.
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Haematological data showed no distinct differences between groups. Total leucocytes count was increased in males of some experimental groups, but there was no trend towards higher average leucocytes counts with an increase of Caprolactam in the diet.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No significant differences occurred in serum enzyme values amongst the various groups.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- The results of the urine analyses showed no changes in the composition of the urine which could be attributed to the feeding of Caprolactam.
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- The relative weight of the kidneys and testicles were increased (25 and 18%) at 1.0 % in males. The relative weight of the liver was increased in both sexes (19% in males and 14% in females) at 1.0 %. All other organ weights of test groups were comparable with the control values. The mathematically significantly decreased heart weight of females at 0.5 % is not considered of toxicological importance, because it was not observed at the 1.0 % level.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- At autopsy, the kidneys of male rats showed a pale-greenish discolouration at the highest dose level. Other gross changes attributable to the ingestion of Caprolactam were not seen.
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- At microscopic examination pathological changes related to the ingestion of Caprolactam were found in the kidneys of males only. These changes consisted of hyaline-droplet degeneration of the proximal convoluted tubules in the kidneys of nearly all male rats at 0.1 % Caprolactam and above. Its degree was distinctly dose-related. The swollen epithelial cells of these tubules showed a granular cytoplasm,caused by large accumulations of tiny droplets of precipitated proteinaceous material. The droplets stained deeply red with Azan. At the 0.05 % level these changes were completely absent.
The other abnormalities were about equally distributed amongst test and control animals. The pathological examinations indicate that the ingestion of Caprolactam at levels of 0.1 % and above is nephrotoxic for male rats of this particular strain (SD).
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 29 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- histopathology: non-neoplastic
- Dose descriptor:
- NOEL
- Effect level:
- 342 mg/kg bw/day (actual dose received)
- Sex:
- female
- Basis for effect level:
- 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.
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.
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