Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well conducted and reported study according to GLP
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 412
Deviations:
yes
Remarks:
exposure until day 5 only
GLP compliance:
yes (incl. certificate)
Test type:
other: subacute
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity 91.7%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
clean air
Details on inhalation exposure:
A dust aerosol was generated
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetry
Duration of exposure:
6 h
Remarks on duration:
per day 5 consecutive days
Concentrations:
0, 30, 300 and 1000 mg/m3
No. of animals per sex per dose:
10 per group main study
10 per group (control and high concentration; recovery groups)
Control animals:
yes

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
other: LC30
Effect level:
1 000 mg/m³ air (nominal)
Based on:
test mat.
Exp. duration:
6 h
Mortality:
6 out of 20 animals of the high concentration group died after the first exposure or the day after. The others of this group were kept for 14 days (as if it were an acute inhalation study).
Clinical signs:
other: Several respiratory tract changes
Body weight:
Decreased
Gross pathology:
Congestion, oedema and multifocal haemorrhages in animals of the high concentration group

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
Based on a 6-h LC30 value (30% mortality folowing a 6-h exposure), it may be assumed that the 4-h LC50 value will be between 1000 and 5000 mg/m3.