Vinyl 2-ethylhexanoate

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Materials and methods

Test guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Vinyl 2-ethylhexanoate

EC Number:

202-297-4

EC Name:

Vinyl 2-ethylhexanoate

Cas Number:

94-04-2

Molecular formula:

C10H18O2

IUPAC Name:

ethenyl 2-ethylhexanoate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Analytical verification of doses or concentrations:

yes

Duration of treatment / exposure:

Gestation days 6-15

Frequency of treatment:

once per day

No. of animals per sex per dose:

25 mated female rats

Control animals:

yes, concurrent vehicle

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

1

Dose descriptor:

NOAEL

Effect level:

750 mg/kg bw/day (actual dose received)

Basis for effect level:

other: maternal toxicity

2

Dose descriptor:

NOAEL

Effect level:

350 mg/kg bw/day (actual dose received)

Basis for effect level:

other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:yes

Details on embryotoxic / teratogenic effects:
Reduced foetal body weight described as follows:
Increased incidence of the external skeletal malformation filamentous tail (3 foetuses had filamentous tail, this was statistically significant and outside historical control incidence) Incidence concurrent controls 0%, historical controls (0.6% foetal basis 9.1% litter basis), 750 mg/kg/day VEHA (1% foetal, 13% litter).
Increased incidence of several skeletal developmental variations (14th rudimentary ribs, 27 presacral vertebrae, bent ribs, 7th cervical ribs)
Reduced ossification (vertebral arches), sternebrae 5 and/or 6 unossified
Reduced number of ossified cervical centrum no. 1 among

Effect levels (fetuses)

Key result

Dose descriptor:

NOAEL

Effect level:

350 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

skeletal malformations

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

NOEL maternal toxicity 750 mg/kg/day
NOEL developmental toxicity 350 mg/kg/day

Executive summary:

In the main study, groups of 25 mated female rats received oral doses (gavage) of 0, 100, 350 and 750 mg/kg/day on days 6-15 of gestation administered in corn oil. There was no evidence of maternal toxicity at any dose level. Developmental toxicity was observed at 750 mg/kg/day. Vinyl 2 -ethylhexanoate is a developmental toxicant in rats in the absence of maternal toxicity causing a slight increase in the external malformation filamentous tail together with various skeletal variants, reduced ossification and reduced foetal body weight indicative of developmental retardation. The NOEL for maternal toxicity was 750 mg/kg/day and the NOEL for developmental toxicity was 350 mg/kg/day.