Vinyl chloroacetate

Toxicity to reproduction

Administrative data

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.

Data source

Reference

Reference Type:

other: Expert assessment

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Vinyl chloroacetate

EC Number:

219-834-3

EC Name:

Vinyl chloroacetate

Cas Number:

2549-51-1

Molecular formula:

C4H5ClO2

IUPAC Name:

ethenyl 2-chloroacetate

Test material form:

liquid

Results and discussion

Results: P1 (second parental generation)

Effect levels (P1)

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

Results: F1 generation

Effect levels (F1)

Remarks on result:

not measured/tested

Target system / organ toxicity (F1)

Critical effects observed:

no

Overall reproductive toxicity

Key result

Reproductive effects observed:

no

Applicant's summary and conclusion

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.