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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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

Constituent 1
Chemical structure
Reference substance name:
2-nitroaniline
EC Number:
201-855-4
EC Name:
2-nitroaniline
Cas Number:
88-74-4
Molecular formula:
C6H6N2O2
IUPAC Name:
2-nitroaniline
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 or test system 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:
other: Tremors, convulsions, narcotic-like state, yellow urine.
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