Registration Dossier

Administrative data

Endpoint:
specific investigations: other studies
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
The study was performed according to a valid guideline without any deviations and was conducted under GLP conditions. Furthermore, the data were submitted by another legal entity, under Directive 67/548/EEC, at least 12 years previously. The registrant has been granted permission to use the information, which has been extracted from the ECHA databases, for REACH registration purposes. No full information related to the experimental result are available but these deficiencies do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Test proeedure: EPA TSCA Guidelines
Deviations:
not specified
GLP compliance:
not specified
Type of method:
in vivo
Endpoint addressed:
acute toxicity: inhalation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
no data

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
Fiseher 344, Charles River

Administration / exposure

Route of administration:
inhalation
Vehicle:
not specified
Details on exposure:
A 14-day sub-chronic inhalation study in the rat was performed.
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
no data
Duration of treatment / exposure:
14 days
Frequency of treatment:
no data
Post exposure period:
no data
Doses / concentrationsopen allclose all
Dose / conc.:
900 mg/m³ air
Dose / conc.:
300 mg/m³ air
Dose / conc.:
90 mg/m³ air
Dose / conc.:
30 mg/m³ air
Dose / conc.:
9 mg/m³ air
Dose / conc.:
0 mg/m³ air
Remarks:
control dose
No. of animals per sex per dose:
Refers to the table
Control animals:
yes
Details on study design:
no data

Examinations

Examinations:
no data
Positive control:
no data

Results and discussion

Details on results:
900 mg/m3 was considered to be the highest reasonably achievable concentration

Any other information on results incl. tables

       
       
 Grp (mg/m3)  target exposure eone.  male  female
 1  control  5  5
 2  9  5  5
 3  30  5  5
 4  90  5  5
 5 300   5  5
 6  900  5  5

Applicant's summary and conclusion

Conclusions:
900 mg/m3 was considered to be the highest reasonably achievable concentration for a 90-day sub-chronic inhalation study.
Executive summary:

A 14-day sub-chronic inhalation study in the rat was performed in order to establish the range for the 90-day sub-chronic inhalation study.

900 mg/m3 was considered to be the highest reasonably achievable concentration.