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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

The assessment of the toxicokinetics behaviour of VCA indicates that the substance will undergo rapid hydrolysis following oral exposure. As a result it is considered that the toxicity of the substance to reproduction following oral exposure will be driven by the toxicity to reproduction of its main degradation products, acetaldehyde and chloroacetic acid. Therefore the reproductive toxicity of VCA was assessed based on available information on the degradation products.

It was not possible to identify in the literature dedicated studies investigating the effects of acetaldehyde and chloroacetic acid to fertility. However the effects of these substances to the reproductive organs – and therefore to fertility – following oral exposure were investigated during repeated-dose toxicity studies. Information was identify in the literature regarding the developmental toxicity of acetaldehyde and chloroacetic acid.

No evidences were identified in the literature indicating that the degradation products of VCA are toxic to reproduction. Both substances are fully registered under REACH and were attributed a Harmonised Classification in accordance with Regulation (EC) No.1272/2008. The available information on the substance regarding its toxicity to reproduction did not lead to the substance being classified as toxic to reproduction. No C&L notification was submitted to ECHA including a classification of the substances as toxic to reproduction. Therefore VCA is not considered as toxic to reproduction.

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Type of information:
other: Expert assessment
Adequacy of study:
weight of evidence
Study period:
2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Expert assessment based on literature data on the degradation products of VCA
Justification for type of information:
An experimental study to determine the toxicity of VCA to reproduction was not considered necessary, nor scientifically justified, since the registered substance is expected to undergo rapid degradation following an oral exposure. Therefore this assessment was based on the degradation products of VCA.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Expert assessment based on literature data on the degradation products of VCA.
GLP compliance:
no
Limit test:
no
Key result
Dose descriptor:
NOAEL
Effect level:
76.67 mg/kg bw/day (nominal)
Sex:
male/female
Basis for effect level:
gross pathology
histopathology: non-neoplastic
Remarks on result:
not measured/tested
Critical effects observed:
no
Key result
Reproductive effects observed:
no
Conclusions:
No evidences were identified in the literature indicating that the degradation products of VCA are toxic to reproduction. Therefore VCA is not considered as toxic to reproduction.
Executive summary:

The assessment of the toxicokinetics behaviour of VCA indicates that the substance will undergo rapid hydrolysis following oral exposure. As a result it is considered that the toxicity of the substance to reproduction following oral exposure will be driven by the toxicity to reproduction of its main degradation products, acetaldehyde and chloroacetic acid. Therefore the reproductive toxicity of VCA was assessed based on available information on the degradation products.

It was not possible to identify in the literature dedicated studies investigating the effects of acetaldehyde and chloroacetic acid to fertility. However the effects of these substances to the reproductive organs – and therefore to fertility – following oral exposure were investigated during repeated-dose toxicity studies. Information was identify in the literature regarding the developmental toxicity of acetaldehyde and chloroacetic acid.

No evidences were identified in the literature indicating that the degradation products of VCA are toxic to reproduction. Both substances are fully registered under REACH and were attributed a Harmonised Classification in accordance with Regulation (EC) No.1272/2008. The available information on the substance regarding its toxicity to reproduction did not lead to the substance being classified as toxic to reproduction. No C&L notification was submitted to ECHA including a classification of the substances as toxic to reproduction. Therefore VCA is not considered as toxic to reproduction.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
76.67 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Expert assessment based on literature data on the degradation products of VCA
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

It is expected that the toxicity to reproduction of the registered substance will be driven by the toxicity of its degradation products chloroacetic acid and acetaldehyde. These degradation products do not meet the criteria for classification as toxic to reproduction according to Regulation (EC) No.1272/2008. Therefore VCA is not considered as toxic to reproduction.

Additional information