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: Assessed after consultation with the relevant Authority. Data migrated from NONS (67/548/EEC notification) files provided by Authority contained insufficient information.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Remarks:
No further information was provided in the SNIF file.
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:

- Physical form of substance: L
- Mass median aerodynamic diameter (for liq+solid aerosol): 4 my
- Analvtical purity: no data

Test animals

Species:
rat
Strain:
other: Sprague Dawley CDR
Sex:
male/female

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
other: none
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION

- Exposure chamber volume: 100 L room


Duration of exposure:
4 h
Concentrations:
4.8 mg/L
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC0
Effect level:
4.8 mg/L air
Based on:
not specified
Exp. duration:
4 h
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 50 mg/L air
Based on:
not specified
Exp. duration:
4 h
Mortality:
Male: 4.8 mg/L, Number of animals: 5, Number of deaths: 0
Female: 4.8 mg/L, Number of animals: 5, Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: Breathing difficulties, nasal discharge, tearing, salivation and tremors were observed during the exposure. Up to 3 weeks afte the exposure, difficulty breathing, nasal discharge and redness of the skin of the ex
Body weight:
The animals lost weight.
Gross pathology:
Effects on organs:
colour changes in the lung tissue 2 males.

Reddish or brownish discoloration of the skin of all the males and 3 females.

Applicant's summary and conclusion