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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

Carcinogenicity
Administrative data
Description of key information
A GLP-compliant combined repeated dose and carcinogenicity study according to OECD 453 was conducted with male and female rats and mice. In both animal species, body weight and weight gain was affected but no adverse effects occurred concerning carcinogenicity. Therefore, the test item is not considered to be classified for carcinogenicity.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to the Read-across Statement attached in Section 13.2.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The underlying hypothesis for the read-across is that the target substance is very prone to hydrolysis resulting in the formation of epsilon-caprolactam and sodium hydroxide. As hydrolysis of the target substance will inevitably occur both under physiological and under environmental conditions, the evaluation of the data of epsilon-caprolactam and sodium hydroxide is considered to be sufficient for hazard assessment. Thus, the toxicological behavior of BRUGGOLEN® C10 can be considered to be determined by the hydrolysis products caprolactam and caustic soda.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Target substance: sodium caprolactamate, CAS-No. 2123-24-2 (for detailed composition please refer to the Read-across Statement attached in Section 13.2)
Source substances: epsilon-caprolactam, CAS-No. 105-60-2 and sodium hydroxide, CAS-No. 1310-73-2
3. ANALOGUE APPROACH JUSTIFICATION
The justification of the read-across hypothesis is mainly based on the hydrolysis of the target substance into the source substances.
BRUGGOLEN® C10 is a combination of sodium caprolactamate (17 – 20 %) and epsilon-caprolactam (80 – 83 %). If diluted in water, sodium caprolactamate easily degrades to caprolactam and sodium hydroxide (caustic soda). Reason is the instability of the ionic N-Na-bond of the sodium caprolactamate.
Thus, the toxicological behavior of BRUGGOLEN® C10 can be considered to be determined by the hydrolysis products caprolactam and caustic soda.
4. DATA MATRIX
Please refer to the Read-across Statement attached in Section 13.2. - Reason / purpose for cross-reference:
- read-across source
- Dose descriptor:
- NOAEL
- Effect level:
- 3 750 ppm
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Dose descriptor:
- NOAEL
- Effect level:
- 7 500 ppm
- Sex:
- male/female
- Basis for effect level:
- histopathology: neoplastic
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 375 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of the study and the absence of adverse effects concerning carcinogenicity the test item is not considered to be classified for carcinogenicity.
Additional information
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