Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-05-24 to 1989-06-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study reliable without restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
adopted 1981-05-12
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
clean air
Analytical verification of test atmosphere concentrations:
yes
Remarks:
please refer to "Details on inhalation exposure" above
Duration of exposure:
4 h
Concentrations:
Actual concentration: 5.04 ± 1.01 mg/L air
No. of animals per sex per dose:
5 males / 5 females
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.04 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LC50 (male and female rats) > 5.04 mg/L air (analytical)
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic by the inhalation route.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic by the inhalation route.