Registration Dossier

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
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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
As per Vinyl Neodeconoate IUCLID4 Data Set

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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).