Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Unsuitable test system (inhalation hazard test with a solid)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
adopted 1981, Annex
Deviations:
yes
Remarks:
(determination of the test atmosphere by reweighing of a test substance column)
Principles of method if other than guideline:
7 h full body exposure to an atmosphere generated by blowing air through a layer of the test substance.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Naphthalimid fest (solid)
- Physical state: solid
- Analytical purity: < 99.5%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Mean weight at study initiation: males 219 g, females 178 g

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
Rats were exposed for 7 h to a dust atmosphere in two trials with 6 animals per trial.
Dust was generated by bubbling 200 L/h dry air (no CO2) through a solid substance column of about 5 cm above a fritted glass disc in a glass cylinder at room temperature. The mean nominal concentration was stated in the raw data to be 0.13 mg/L, calculated on the basis of weight reduction of the substance column during the exposure period.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
7 h
Concentrations:
nominal 0.13 mg/L
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weighing was done on d0 and d14. Detailed clinical observations were performed several times at the day of exposure and daily with the exception of weekends and holidays afterwards.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: IHT
Exp. duration:
7 h
Remarks on result:
other: No mortality observed after dust exposure for 7 hours.
Mortality:
No mortality observed.
Clinical signs:
not observed
Body weight:
normal body weight gain
Gross pathology:
Nothing abnormal found.

Any other information on results incl. tables

A weak dust formation was observed.

Applicant's summary and conclusion