Registration Dossier

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:
data from handbook or collection of data

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
RTECS: Ammonium, (9-(o-carboxyphenyl)-6-(diethylamino)-3H-xanthen-3-ylidene)diethyl-, chloride
Author:
unknown
Year:
1961
Bibliographic source:
RTECS number BP3675000 citing TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1-1959- Volume(issue)/page/year:3,696,1961
Reference Type:
review article or handbook
Title:
RTECS: Ammonium,(9-(o-carboxyphenyl)-6-(diethylamino)-3H-xanthen-3-ylidene)diethyl-, chloride
Author:
unknown
Year:
1963
Bibliographic source:
RTECS no BP3675000 citing Gigiena Truda i Professional'nye Zabolevaniya. Labor Hygiene and Occupational Diseases.(V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.1-36,1957-1992. For publisher information, see MTPEEI.Volume(issue)/page/year: 7(2),34,1963

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: no information on the method
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
not specified
Doses / concentrations
Dose / conc.:
110 other: mg/kg/13W-I
No. of animals per sex per dose:
not specified
Control animals:
not specified

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Nutritional and Gross Metabolic - weight loss or decreased weight gain
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
Lungs, Thorax, or Respiration - structural or functional change in trachea or bronchi
Histopathological findings: neoplastic:
not specified

Effect levels

Remarks on result:
not measured/tested

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Basic violet 10 was administered by inhalation route to rats for 13 weeks.
Some effects were observed: structural or functional change in trachea or bronchi, weight loss or decreased weight gain, death.
The Lowest published toxic dose (TDLo) was 110 mg/kg/13W-I.
No further information was provided.