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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:
weight of evidence
Study period:
Oct 1974
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:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Male rats were administered the test substance by oral gavage. The application was followed by a 14-d observation period and thereafter the animals were sacrificed.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Basic Blue 45 MeSO4

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Breeder: Winkelmann, Borchen
Age: ca. 8 weeks old
Body weight: 150-200 g
Temperature and relative humidity: 22 +/- 1.5°C and 60 +/- 5%, respectively
Light period: 12 h light - 12 h dark
Feed: Altromin R 1324

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Dose volume applied: 20 mL/kg bw
Doses:
3000, 3500, 4000, 4500, 5000, 6300 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs
Statistics:
Probit analysis

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
4 068 mg/kg bw
Based on:
test mat.
95% CL:
> 3 735 - < 4 418
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
2 115 mg/kg bw
Based on:
act. ingr.
Mortality:
0/10 at 3000 mg/kg bw, 3/10 at 3500 mg/kg bw, 5/10 at 4000 mg/kg bw, 7/10 at 4500 mg/kg bw, 8/10 at 5000 mg/kg bw, 10/10 at 6300 mg/kg bw
Clinical signs:
Sedation, breathing difficulties, seizures

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the LD50 (oral, gavage) of the test substance in male rats was determined at 2115 mg/kg bw (act. ingr.). The substance is not classifiable according to CLP criteria.