Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study is comparable with the inhalation hazard test described in the Annex of OECD Guideline 403 (adopted 1981) with acceptable restrictions mostly due to reduced documentation and no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report Date:
1963

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
Analytical purity of the test substance not reported
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: N-vinylcaprolactam dest.

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Mean weight at study initiation: 160.5 g (calculated from the raw data)

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
Vapour was generated by bubbling 200 l/h dry air (no CO2) through the test substance column of about 5 cm above a fritted glass disc in a glass cylinder. The glass cylinder was heated in a water bath to two different temperatures, 20 and 50°C. Concentrations stated in the raw data were 1.12, 1.36 and 1.6 mg/L generated by heating the water bath to 50°C, and 0.2 and 0.3 mg/L generated by heating the water bath to 20°C.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
8 h
Concentrations:
0.2, 0.3, 1.12, 1.36 and 1.6 mg/L
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: clinical signs were recorded several times on the day of administration and at least once per workday for the individual animals; weighing on day 0 before administration.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, mean body weight
Statistics:
not performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1.6 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
8 h
Mortality:
No mortality was observed.
Clinical signs:
No clinical signs were observed.
Body weight:
No effect on the body weight gain was observed.
Gross pathology:
No abnormalities were noted.

Applicant's summary and conclusion