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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

Endpoint summary
Administrative data
Description of key information
Acute toxicity, oral:
Data from direct determination of toxicity of sodium caprolactamate as
defined in section 1. Sodium caprolactamate is harmful if swallowed.
LD50 oral (rat) = 300-2,000 mg/kg bw (female). For calculation the LD50
value 1450 mg/kg derived from epsilon-Caprolactam will be used.
Acute toxicity, inhalative:
Data from epsilon-Caprolactam will be used (a safety factor of 2 is
applied): LC50 inhalative = 3.5 mg/L.
Acute toxicity, dermal:
The substance is corrosive to skin; therefore no toxicity data can be
transferred from epsilon-Caprolactam. The substance has to be classified
accordingly.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2,000 mg/kg
300 mg/kg - No. of animals per sex per dose:
- Treated group (2000 mg/kg): 6 female rats
Treated group (300 mg/kg): 6 female rats - Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 14 days after administration of the test item. The animals were weighed on day D0 (just before administering the test item) then on D2, D7, and D14.
Weight changes were calculated and recorded.
- Necropsy of survivors performed: On D14, the animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels.
- Other examinations performed: Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. Those presenting macroscopic anomalies can be removed and preserved in view to microscopic exanimations. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- It was noted the death of 4 treated rats treated at 2000 mg/kg b.w., 7, 8 and 24 hours after the test item administration.
No mortality occurred in the animals treated at 300 mg/kg b.w.. - Clinical signs:
- other: It was registered in the animals treated at 2000 mg/kg, 30 minutes after the test item administration, a decrease of the spontaneous activity (6/6) associated with a piloerection (4/6) and a decrease of the righting reflex (1/6) at the reading time 4 hour
- Gross pathology:
- The macroscopical examination of the animals treated at 2000 mg/kg which died during the test revealed the presence of black foci on the corpus and a decrease of vascularisation on the forestomach (4/4).
The macroscopical examination of the animals treated at 2000 mg/kg at the end of the study revealed a
white thickening layer at the level of the forestomach (2/2).
The macroscopical examination of the animals treated at 300 mg/kg at the end of the study did not reveal treatment-related changes. - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- LD50>300 mg/kg bw
LD50<2,000 mg/kg bw - Executive summary:
In conclusion, the LD50 cut-off of the test item Sodium caprolactamate in caprolactam is 2000 mg/kg
body weight by oral route in the rat.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item needs to be
classified in category 4. The signal work “warning” and hazard statement H302 “Harmful if
swallowed” are required.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 300 mg/kg bw
- Quality of whole database:
- Good, several GLP guideline studies available
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key 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
- 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:
- 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
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 3 500 mg/m³ air
- Quality of whole database:
- Acceptable.
The LC50 is estimated from the lowest LC50 of epsilon-Caprolactam resulting in an ATE =3.5.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of acute toxicity – oral endpoint
GLP study with substance itself
Justification for selection of acute toxicity – inhalation endpoint
Sodium caprolactamate hydrolyses under physiological conditions with
the formation of epsilon-Caprolactam and sodium hydroxide, cross-reading
from toxicological studies of epsilon-Caprolactam is justified.
Therefore in spite of the corrosivness of sodium caprolactamate, also
the effects of epsilon-caprolactame have to be taken into consideration.
The study allows to estimate the acute toxicity via inhalation route.
Justification for classification or non-classification
Classification of the toxicity of the substance (including read-across from epsilon-Caprolactam) based on section 3.1.3.6.2.3 of CLP Regulation:
Oral: ATE = 500: acute oral category 4, H 302
Dermal: Corrosive, no acute dermal classification
Inhalative: ATE = 3.5: acute inhalative category 4, H 332
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