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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)
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.
According to Column 2 of Section 8.5 of Annex VIII details specific rules for adaptation, notably requiring information on at least one other route of exposure depending on the nature of the substance and the likely route of human exposure.
Considering the chemico-physical characteristics of the substance and the likely route of human exposure, it was judged as priority and essential to submit information related to acute toxicity by inhalation route.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
432-240-0
EC Name:
-
Cas Number:
12056-51-8
Molecular formula:
K2Ti6O13
IUPAC Name:
hydrate potassium hydride titanium
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Physical form of substance: S
Mass median aerodynamic diameter (for liq.+solid aerosol): 1st sample: mean fibre length = 16.21 microm
mean fibre width = 7.41 microm
2nd sample: mean fibre length = 14.51 microm
mean fibre width = 7.61 microm

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
not specified
Details on inhalation exposure:
no data
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
no data
No. of animals per sex per dose:
5 animals/sex/group
Control animals:
not specified
Details on study design:
no data
Statistics:
no data

Results and discussion

Preliminary study:
no data
Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1.9 mg/L air
Based on:
not specified
Exp. duration:
4 h
Mortality:
Male: 1.9 mg/L; Number of animals: 5; Number of deaths: O
Female: 1.9 mg/L; Number of animals: 5; Number of deaths: O
Clinical signs:
other: Signs of toxicity related to dose levels: No deaths occurred. Clinical signs of nasal discharge, ocular discharge and ruffled fur occurred alter exposure and persisted for several days. There were no other visible effects.
Body weight:
no data
Gross pathology:
Effects on organs:
Necropsy findings revealed no gross lesions or abnormalities of any kind.
Other findings:
no data

Any other information on results incl. tables

no data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the LD50 of the test material was determined to be > 1.9 mg/L air (4h): the substance is not classified, in accordance to CLP criteria.
Executive summary:

Under the conditions of the study, the LD50 of the test material was determined to be > 1.9 mg/L air (4h): the substance is not classified, in accordance to CLP criteria.