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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study report, acceptable for assessment

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Standard acute method before coming into effect of the OECD testing guideline.
The test substance was administered to 10 female SPF-Wistar rats/dose group at doses of 800, 1250, 1600, 2000, and 3200 mg/kg bw by gavage in a starch emulsion. The animals were observed during the 14-days post-observation time for lethality, and clinical signs of intoxictation.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Echtorange GR Base = 2-nitro-1-aminobenzol
- Analytical purity: 98.5-99.5% base

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: SPF-Wistar
- Source: Hoechst AG breed
- Weight at study initiation: 80 - 110 g (mean: 94 g)
- Fasting period before study: yes, 16 hours
- Diet (ad libitum): Altromin 1324 (Altrogge, Lage/Lippe, Germany)
- Water (ad libitum): tap water


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: starch emulsion 10 %
Doses:
800, 1250, 1600, 2000, and 3200 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
- Frequency of observations and weighing: before test start, after 7 and 14 days
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, body weight
Statistics:
The LD50 was determined by means of probit analysis according to the method by Lindner and Weber. Confidence limits were calculated following Cavalli-Sporza

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
1 838 mg/kg bw
Based on:
test mat.
95% CL:
1 673 - 2 018
Mortality:
At the two lowest doses, all animals survived until study termination. At 1600 and 2000 mg/kg bw 2/10 and 7/10 animals died, respectively. At the highest dose all animals died within 24 hours after administration.
Clinical signs:
Tremors, convulsions, narcotic-like state, yellow urine.
Body weight:
No abnormalities.
Gross pathology:
No abnormalities in the deceased animals.

Any other information on results incl. tables

Dose [mg/kg bw]

Concentration [%]

Dead animals/animals tested

800

10

0/10

1250

10

0/10

1600

10

2/10

2000

10

7/10

3200

10

10/10

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU