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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:
1965
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Internal Guideline Hoechst AG
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Reactive Red 23

Test animals

Species:
rat
Strain:
other: mixed-race albino
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 80 - 110g (average: 93 g)
- Fasting period before study: 12 h
- Diet (e.g. ad libitum): standard ALTROMIN, ad libitum
- Water (e.g. ad libitum): mains water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 2 % starch
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25 %
Doses:
2.5, 4.0, 6.3 and 10.0 g/kg body weight
No. of animals per sex per dose:
10 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
Determination of LD50: graphical in probability grid

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat.
95% CL:
> 4 800 - < 5 300
Mortality:
mortality in doses 4.0, 6.3 and 10.0
death occured 24h after application
Clinical signs:
no effects

Any other information on results incl. tables

Dose level [g/kg bw]

Mortality 
 2.5  0/10
 4.0  2/10

 6.3

 8/10

10.0 10/10

Deaths occurred within 24 hours after test substance administration.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 to female rat was calculated to be 5000 mg/kg bw. The substance is not classifiable according to CLP criteria.