Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: publication not sufficient for full methodological assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Guideline:
other: detailed description of methodology not published
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: particles suspended in an air stream

Test animals

Species:
rat
Strain:
other: Crl:CD

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetric analsysis at 1/2 hour intervals during each exposure, particle size properties determined during each exposure
Duration of exposure:
4 h
Remarks on duration:
single exposure time for each of 3 group
Concentrations:
1. 1st group of 6 rats: range 2.2 - 11 mg/l, mean 4.8 mg/l, standard deviation 3.1 mg/l; particle size 73% respirable, mass median diameter 2.0µ
2. 2nd group of 6 rats: range 1.7 - 21 mg/l, mean 12 mg/l, standard deviation 7.4 mg/l; particle size 45% respirable, mass median diameter 5.0µ
3. 3rd group of 6 rats: range 5 - 18 mg/l, mean 13 mg/l, standard deviation 3.8 mg/l, particle size 60% respirable, mass median diameter 8.3µ

Results and discussion

Effect levels
Remarks on result:
other: Lethal concentration not assignable since none of the rats of each group showed a lethal reaction at a concentration of 13 mg/l, the highest possible concentration generated under the experimental conditions
Mortality:
none of the rats of each group showed a lethal reaction at a concentration of 13 mg/l, the highest possible mean concentration generated under the experimental conditions
Body weight:
slight initial weight loss followed by gain of weight

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: other: Interpretation of literature data
Conclusions:
The NOAEL of 13 mg/l is above the threshold for classification according to Regulation (EC) no. 1272/2008, Directive 67/548/EEC respectively. Hence the substance is not needed to be classified.