Vinyl chloroacetate

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

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 following a repeated oral exposure 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

Effect levels

Key result

Dose descriptor:

NOAEL

Effect level:

4.48 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

body weight and weight gain

organ weights and organ / body weight ratios

Target system / organ toxicity

Critical effects observed:

no

Applicant's summary and conclusion

Conclusions:

The short-term repeated-dose toxicity of VCA following an oral exposure is expected to be driven by its degradation product chloroacetic acid as it was shown to be more hazardous than acetaldehyde following a repeated exposure by the oral route. Therefore the NOAEL of 4.48 mg/kg bw/d derived from a chronic toxicity study shall be used for the short-term repeated-dose toxicity of VCA. This value is conservative and considered to cover the adverse effects induced by the two main degradation products of VCA.

Executive summary:

The toxicity of VCA following short-term repeated oral exposure was assessed based on the toxicokinetics behaviour of the substance and the available information on the repeated-dose toxicity of its degradation products acetaldehyde and chloroacetic acid.

The short-term repeated dose toxicity of acetaldehyde by the oral route was investigated and allowed to derive a NOAEL of 125 mg/kg bw/d (equivalent to an ingestion of 341.25 mg/kg bw/d of VCA). The

The repeated dose toxicity of chloroacetic acid by the oral route was investigated and a NOAEL of 3.5 mg/kg bw/d (equivalent to an ingestion of 4.48 mg/kg bw/d mg/kg bw/d of VCA) from a chronic toxicity study was identified. This value is considered as conservative in order to assess the short-term (4 weeks) repeated dose toxicity of VCA.

 

It can be expected from these results that the short-term repeated-dose toxicity of VCA following an oral exposure will be driven by its degradation product chloroacetic acid as it was shown to be more hazardous than acetaldehyde following a repeated exposure. Therefore the NOAEL of 4.48 mg/kg bw/d derived from a chronic toxicity study shall be used for the short-term repeated-dose toxicity of VCA. This value is conservative and considered to cover the adverse effects induced by the two main degradation products of VCA.