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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1974
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:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
observation period reduced to 7 d
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-[[4-[(3,5-dinitro-2-thienyl)azo]phenyl]imino]bisethyl diacetate
EC Number:
255-940-6
EC Name:
2,2'-[[4-[(3,5-dinitro-2-thienyl)azo]phenyl]imino]bisethyl diacetate
Cas Number:
42783-06-2
Molecular formula:
C18H19N5O8S
IUPAC Name:
2,2'-[[4-[(3,5-dinitro-2-thienyl)azo]phenyl]imino]bisethyl diacetate
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
other:
Remarks:
Alderley Park SPF
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd.m Margate, UK
- Age at study initiation: ca. 1 month
- Weight at study initiation: ca. 150 g
- Fasting period before study: 16 - 20 h before dosing
- Housing: steel cages, 50 x 30 x 18 cm
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: >= 7d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23°C
- Humidity (%): 40 - 60% r.h.
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other:
Remarks:
20% aqueous solution of inert surfactant Dispersol OG
Doses:
2000 and 4000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 d
- Frequency of observations and weighing: daily, no weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality at 2000 and 4000 mg/kg bw
Clinical signs:
other: all animals excreting red urine until 24 h after dosing
Gross pathology:
2/3 males and 2/3 females at 4000 mg/kg bw showing haemopoiesis of spleen

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 (oral, gavage) in male and female rats was determined to be >4000 mg/kg. Therefore, the substance is not classifiable according to the CLP Regulation.