Vinyl neodecanoate

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Only the study report was audited for GLP compliance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Principles of method if other than guideline:

O.E.C.D. 413 Subchronic Inhalation Toxicity: 90-Day Study

GLP compliance:

yes

Remarks:

Study report was audited for GLP compliance.

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

Vinyl neodecanoate

EC Number:

256-905-8

EC Name:

Vinyl neodecanoate

Cas Number:

51000-52-3

Molecular formula:

C12H22O2

IUPAC Name:

vinyl neodecanoate

Details on test material:

As per Vinyl Neodeconoate IUCLID4 Data Set

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

As per study protocol and O.E.C.D. 413 Testing guideline.

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure (if applicable):

whole body

Vehicle:

unchanged (no vehicle)

Details on exposure:

Groups of 18 male and 18 female rats were exposed to nominal concentrations of 0.25 (low), 0.50 (medium) and 1.0 g m3 (high) for 6 hours! day, 5 days/week for 13 weeks. Similar numbers of control animals were housed in an identical chamber, but exposed to air only.

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

The chamber atmospheres were analysed continuously by means of dedicated total hydrocarbon analysers fitted with flame—ionisation detectors.

Duration of treatment / exposure:

Six hours/day

Frequency of treatment:

Daily

Duration of test:

90 days in-life

Doses / concentrations

Remarks:

Doses / Concentrations:
Nominal concentrations of: 0, 0.25 (low), 0.50 (medium) and 1.0 g m3 (high)
Basis:
nominal conc.

No. of animals per sex per dose:

18

Control animals:

yes, sham-exposed

Details on study design:

See Robust Study Summary in Section 7.5, Repeat dose toxicity.

Statistics:

The significance of any difference between treated and control group means was tested using the William's t-test and Dunnett's test was used when monotonic dose response could not be assumed.

Results and discussion

Effect levels

Dose descriptor:

NOAEC

Effect level:

>= 500 mg/m³ air (nominal)

Sex:

male/female

Basis for effect level:

other: EInhalation of up to 1.0 gm/m3 (approximately 123 ppm) for 6 hr/day for 90 days did not result in any adverse reproductive organ effects in male and femalee rats.

Observed effects

There were no adverse histopathological findings made in the ovaries, testes, uterui or prostate gland.

Applicant's summary and conclusion

Conclusions:

Inhalation of up to 1.0 gm/m3 (approximately 123 ppm) for 6 hr/day for 90 days did not result in any adverse reproductive organ effects in male and femalee rats.

Executive summary:

Inhalation of up to 1.0 gm/m3 (approximately 123 ppm) for 6 hr/day for 90 days in an O.E.C.D. 413 Testing Guideline Subchronic 90 -day inhalation study did not result in any adverse reproductive organ effects in male and female rats. Therefore the NOAEC for adverse reproductive organ effects in laboratory rats under the conditons of this 90 -day inhaltion study is 1.0 gm/m3 (123 ppm).