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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1989 - March 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards and acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
other company data
Title:
Unnamed
Year:
1990
Report Date:
1990
Reference Type:
other company data
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
- Principle of test: equivalent or similar to a standard acute method- Parameters analysed / observed: mortality and clinical signs of intoxication
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
solid: particulate/powder
Details on test material:
Other name: Saturnová nám. modř LFG konc. ; sample No. 196/89

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS- Source: not specified- Age at study initiation: not specified- Weight at study initiation: 140 - 158g- Fasting period before study: not specified- Housing: individually in cage - Diet (e.g. ad libitum): not specified- Water (e.g. ad libitum): not specified- Acclimation period: not specifiedENVIRONMENTAL CONDITIONSnot specified (laboratory conditions)

Administration / exposure

Route of administration:
other: unspecified, probably gavage
Vehicle:
water
Details on oral exposure:
VEHICLE - Concentration in vehicle: 20%MAXIMUM DOSE APPLIED: 10 g/kg
Doses:
7.943; 10.00, 12.59 g/kg
No. of animals per sex per dose:
10
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
9 607 mg/kg bw
Based on:
test mat.
95% CL:
> 9 024 - < 10 230
Mortality:
yes ( see Any other information on results ...)
Clinical signs:
1/2 hour after aplication both doses diarrhea - the symptom disappeared the next day; 3 hours after dose 10 g rats were languid;
Body weight:
not specified (initial weight 140 - 158g)
Gross pathology:
Coloring of tissues; necropsy after 14 days revealed colour in kidneys, liver and spleen for 10 g dose and for 7.9 dose in kidneys.

Any other information on results incl. tables

Dose[g/kg] Mortality
7.943 0/10
10.000 7/10
12.59 10/10

LD50 = 9.607 (9.024 – 10.230) g/kg b.w.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
very slightly toxic
Executive summary:

The test substance toxicity was evaluated on the basis of mortality and clinical signs of intoxication. According to the study results the value of LD50 of the test substance, Direct Blue 85 (Saturnová námořnická modř LFG konc.), for male rats is 9.607 g/kg of body weight.