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Toxicological information

Carcinogenicity

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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
Reference
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:
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
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

Additional information

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.