Registration Dossier

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 403 (1981)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Physical form of substance: S

Test animals

Species:
other: rat, Wistar (SPF)

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Details on inhalation exposure:
Nose only
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Concentrations:
5000 mg/m3
No. of animals per sex per dose:
5
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.31 mg/L air
Exp. duration:
4 h
Mortality:
Male: 5.31 mg/L; Number of animals: 5; Number of deaths: 1
Female: 5.31 mg/L; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: One male was found dead after 1 day. No other deaths were observed. Clinical signs, characterised by closed eyes, abnormal respiratory sound and adhesion of a blood-like substance to the area surrounding
Gross pathology:
Effects on organs:
In the male that died, soiled fur and adhesion of a
blood-like substance in the area surrounding the nose was
observed. Internal examination revealed hyperemia in the
small intestine. In the animals that survived, there were no
marked changes in the internal or external findings in both
males and females.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not classified