Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study published in Literature. No details on GLP and/or Guideline followed.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Guideline:
other: no data
Principles of method if other than guideline:
See publication for details
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(6-methylbenzothiazol-2-yl)aniline
EC Number:
202-150-4
EC Name:
4-(6-methylbenzothiazol-2-yl)aniline
Cas Number:
92-36-4
Molecular formula:
C14H12N2S
IUPAC Name:
4-(6-methyl-1,3-benzothiazol-2-yl)aniline

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
air
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
10 days: 5 days followed by 2 rest days and 5 more exposure days.
Frequency of treatment:
6h/d
Doses / concentrations
Remarks:
Doses / Concentrations:
0.68 mg/l
Basis:
no data
No. of animals per sex per dose:
10
Control animals:
yes, sham-exposed
Details on study design:
given in publication

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
Changes in Liver weight, changes in spleen weight, Changes in erythrocyte (RBC count)
Mortality:
mortality observed, treatment-related
Description (incidence):
Changes in Liver weight, changes in spleen weight, Changes in erythrocyte (RBC count)
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Weight loss
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
increased serum enzyme activity, kidney turbular degeneration in one rat
Urinalysis findings:
effects observed, treatment-related
Description (incidence and severity):
excetion of large volumes of less concentrated urine
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
increased liver weight
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
Liver changes

Effect levels

open allclose all
Dose descriptor:
other: TCLo
Effect level:
680 mg/kg bw/day (actual dose received)
Sex:
male
Dose descriptor:
conc. level: TCLo
Effect level:
0.68 mg/L air (analytical)
Sex:
male

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The study was performed as a 10 days subchronic study. The results justify a classification as STOT RE 2.