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Diss Factsheets
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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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Principles of method if other than guideline:
- Groups of 10 Wistar rats/sex were exposed to a liquid aerosol of the test substance (50%, w/w) using a head-nose inhalation system.
- GLP compliance:
- no
- Test type:
- standard acute method
- 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:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: 8 weeks
- Mean weight at study initiation: male 250 g (224-268 g) female 178 g (161-192 g)
- Diet (e.g. ad libitum): Kliba labor diet
- Water (e.g. ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other:
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Nose/head - inhalation system INA 20, BASF AG
- Exposure chamber volume: 55 l
- Method of holding animals in test chamber: animals were kept in the tube with muzzle projecting in the inhalation chamber
- System of generating particulates/aerosols: Generatorsystem- infusion pump INFU 362, membrane dose pump Duramat. The aerosol was generated using compressed air.
- Temperature in air chamber: 19-25 °C
TEST ATMOSPHERE
- Brief description of analytical method used: Quantitative determination of aerosol concentration was performed using gas chromatography. For this the aerosol probes were dissolved in 10ml Ethanol.
- Samples taken from breathing zone: yes
- Nominal concentrations were calculated using the substance consumption and the air volume.
- probes for particle size analysis were taken from 30 min after onset of exposure
VEHICLE
- Concentration of test material in vehicle: 50% (w/v) in water - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.25, 8.35 and 10.12 mg/l
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weight of individual animals was measured before treatment and after 7 and 14 days of treatment, daily clinical inspection
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology (anatomical/pathological) - Statistics:
- According to the probit analysis of D.J. Finney, 1-150 (Syndics of the Cambridge University Press, 1971).
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 8.16 mg/L air
- 95% CL:
- 7.2 - 9.23
- Exp. duration:
- 4 h
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- ca. 9.6 mg/L air (analytical)
- Exp. duration:
- 4 h
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- 7.08 mg/L air (analytical)
- 95% CL:
- 5.87 - 8.1
- Exp. duration:
- 4 h
- Mortality:
- see free text
- Clinical signs:
- other: Symptoms during exposure: closure of eyelid, irregular respiration, escape reaction Symptoms after exposure: dyspnoea, piloerection, intermittent respiration, bloody nose and eye discharge, tremor. Clinical signs were reversible after 5 days (low dose), 7
- Body weight:
- No effects on body weight gain were observed
- Gross pathology:
- Severe hyperemia in lungs and liver adiposis in some perished animals. No abnormalities in the sacrificed animals
- Other findings:
- - Histopathology: fatty degeneration in the liver and ischemic tubulonephrosis in the cortex of the kidney of 1 deceased animal. No lesions were observed in the sacrificed animals.
Any other information on results incl. tables
Dose (mg/l) |
Sex |
Mortality within |
||
4 h |
1 day |
14 days |
||
5.25 |
M |
0/10 |
1/10 |
1/10 |
F |
0/10 |
1/10 |
1/10 |
|
8.25 |
M |
0/10 |
1/10 |
1/10 |
F |
0/10 |
7/10 |
7/10 |
|
10.12 |
M |
2/10 |
7/10 |
7/10 |
F |
1/10 |
10/10 |
10/10 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The substance is considered to be classified as "may be harmful if inhaled" according to CLP (Cat.4) and EU (R20) standards.
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