Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
The acute inhalation toxicity study was conducted in rats by using test chemical
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of substance: ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts
- Appearance : pink solid
- Common name: Pigment red 169
- Substance type: UVCBs-organometallic

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
not specified

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
not specified
Vehicle:
air
Remark on MMAD/GSD:
not specified
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: desiccator
- Source and rate of air: 200 ltr./air hours
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
8 h
Remarks on duration:
not specified
Concentrations:
3.66 mg/L
No. of animals per sex per dose:
Total = 12
Control animals:
not specified
Details on study design:
- Necropsy of survivors performed: yes, after a week the animals were killed and dissected
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 3.66 mg/L air
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: No mortality was observed
Mortality:
No mortality was obseved at 3.66 mg/L air concentration in treated rats.
Clinical signs:
Red colored fur was observed.
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The acute inhalation toxicity dose (LC50) value was considered to be >3.66 mg/L air, when 12 male and female rats were treated with test chemical via inhalation route by dust form for 8 hours exposure.
Executive summary:

The acute inhalation toxicity study was conducted by using test chemical in 12 male and female rats at the dose concentration of 3.66 mg/L via inhalation route by dust form. The desiccator was used as inhalation chamber for animals in which source and rate of air was 200 ltr./air hours. The duration of exposure was 8 hours. Necropsy of survivors performed. After a week the animals were killed and dissected. No mortality was obseved at 3.66 mg/L air concentration in treated rats. Red colored fur was observed. Therefore, LC50 value was considered to be >3.66 mg/L air, when 12 male and female rats were treated with test chemical via inhalation route by dust form for 8 hours exposure.