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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan/Feb 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-[[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]-3-chlorophenyl]imino]bisethanol
EC Number:
241-481-9
EC Name:
2,2'-[[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]-3-chlorophenyl]imino]bisethanol
Cas Number:
17464-91-4
Molecular formula:
C16H15BrCl2N4O4
IUPAC Name:
2,2'-[[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]-3-chlorophenyl]imino]bisethanol
Test material form:
liquid
Details on test material:
Disperse Brown 4

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: ca. 12 weeks old
- Housing: 5 animals were kept in per cage (V-II-A-steel cages)
- Fasting period before study: 16 hours before treatment animals received no diet
- Diet (e.g. ad libitum): SSNIFF R from SSNIFF Versuchstierdiaeten, Soest, Germany; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 45 -75
- Air changes (per hr): not identified
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: <15 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5 hours after application. Afterwards once per day the clinical signs were recorded and twice per day mortality was checked.
- Frequency of weighing: before application, and on days 3, 7 and 13 after application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
Probit analysis [Finney D.J., 1971; Cambridge University Press Vol. 3]

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 465 mg/kg bw
Based on:
act. ingr.
Clinical signs:
other: No effects

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 (oral, gavage) in rats was found at 16900 mg/kg bw corresponding to 3465 mg/kg bw act. ingr. The substance is not classifiable according to CLP criteria.