Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to an O.E.C.D. Testing Guideline following the GLP regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
As per IUCLID5 Sections 1.1 -1.4.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Animals were acquired from Charles River (UK) Margate, Kent and were 5-6 weks of age with a body weight range of 113-124 Grams. Animals were housed 5/sex in suspended polypropylene cages with detachable stainless tops and bottoms. The temperature was maintained at 22 c =/- 3 C and a relative humidity range og 30-70%. There were approximately 15-20 air exchanges per hr. a 12 hr light/dark cycle was maintained. Rat and Mouse (Modified) No. 1 Diet SQC Expanded supplied by Special Diets Services, Stepfield, Witham, Essex was available ad libitum. Domestic mains quality drinking water was supplied ad Libitum.

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
The test atmosphere was generated using a vapourising system. Animals were exposed nose-only by loading into tapered polycarbonate restraint tubes and fitted onto the exposure chamber and sealed by means of a push-fit through a rubber 'O' ring.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
by GC analysis
Duration of exposure:
4 h
Concentrations:
0.48-3.23 mg/l
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Animals were exposed to vapours of vinyl neononanoate by nose-only inhalation for 4 hr. Animals were then observed for 1-2 hr post-dosing and then twice daily for clinical signs of toxicity. Body weights were taken on study days, 0, 2, 3, 4, 7, 10 and 14. At the end of the 14-day observation period a macroscopic post mortem was conducted on all surviving animals. The respiratory tract was subjected to a detailed macroscopic examination. Lung weights were taken during necrospy.
Statistics:
None conducted.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: mortality
Effect level:
ca. 3 230 mg/m³ air (nominal)
Exp. duration:
14 d
Mortality:
Two males and one female from group 1 ( high dose 3.23 mg/L) were killed in extremis approximately 1-2 h post dose. There were no deaths in groups 2 or 3.
Clinical signs:
other: Minimal clinical signs were observed at 0.48 and 1.43 mg/l. Animals treated at 3.23 mg/l showed hunched posture, prostrate posture, body tremors, subdued behavior and unsteady gait and exaggerated and violent body movements. Those rats which were killed i
Body weight:
No significant effects were recorded for body weight profiles throughout the observation period.
Gross pathology:
No sifnificant findings.
Other findings:
Lung weights and lung weight/body weight ratios were no impacted by exposure to vinyl neononanoate.

Applicant's summary and conclusion

Interpretation of results:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Approximately 30% mortality was observed at the high dose level of 3.23 mg vinyl neononanoate/L following 4 hr of nose-onlly exposure. Therefore the 4 hr LC50 value is > 3.23 mg/L (~ 430 ppm). Significant evidence of neurotoxicity based upon clinical signs was observed at this toxic dose level.
Executive summary:

Vinyl neononanoate was assessed for acute inhalation toxicity in an O.E.C.D. Testing Guideline study with GLP compliance by nose-only vapour exposure. The 4 hr LC50 value was determined to be > 3.23 mg/L (~ 430 ppm). Significant evidence of neurotoxicity based upon clinical signs was observed at this toxic dose level.