Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 1973
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 dermal 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
Substance type:organic

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
SPF
Sex:
male/female
Details on test animals and environmental conditions:
not specifiedTEST ANIMALS
- Weight at study initiation: Male - 146 g; Female - 122 g

Administration / exposure

Type of coverage:
not specified
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: Back p.c
- % coverage: 50%
VEHICLE
- Concentration (if solution): 50% solution in distilled water
Duration of exposure:
24 hours
Doses:
2500 mg/kg
No. of animals per sex per dose:
5 male and 5 female
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were obsrved for mortality and clinical signs.
- Necropsy of survivors performed: yes, animals were killed after 14 days and necropsied with carbon dioxide
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed
Mortality:
No mortality was observed at 2500 mg/kg bw.
Clinical signs:
During and after application of the 14 days the animals are found blithe. At 24 hour, redness did not recognize in 10/10 animals. On 8 day, red substance residues observed in 10/10 animals.
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The acute dermal toxicity dose (LD50) value was considered to be >2500 mg/kg bw, when 10 male and female Sprague-Dawley SPF rats were treated with test chemical by dermal application based on which it can be concluded that it is non toxic via dermal route.
Executive summary:

The acute dermal toxicity study was conducted by using test chemical in 10 male and female Sprague-Dawley SPF rats at the dose concentration of 2500 mg/kg bw. The given test chemical was dissolved as 50% solution in distilled water and applied on 50% area of back skin of rats. Animals were obsrved for mortality and clinical signs for 14 days. Animals were killed after 14 days and necropsied with carbon dioxide. No mortality was observed at 2500 mg/kg bw. During and after application of the 14 days the animals are found blithe. At 24 hour, redness did not recognize in 10/10 animals. On 8 day, red substance residues observed in 10/10 animals. Therefore, LD50 value was considered to be >2500 mg/kg bw, when 10 male and female Sprague-Dawley SPF rats were treated with test chemical by dermal application based on which it can be concluded that it is non toxic via dermal route.