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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1980-02-19 to 1980-06-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

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:
BASF method
GLP compliance:
no
Remarks:
predates GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-[[3-acetamido-4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]diethyl diacetate
EC Number:
216-251-6
EC Name:
2,2'-[[3-acetamido-4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]diethyl diacetate
Cas Number:
1533-78-4
Molecular formula:
C22H24ClN5O7
IUPAC Name:
2,2'-[[3-acetamido-4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]diethyl diacetate
Test material form:
solid
Details on test material:
Disperse Red 167:1

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
: Wiga
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS:
- Weight at study initiation: males: 230 g/ females: 180 g
- Food: Herilan MRH-Haltung; H. Eggersmann KG
- Fasting period before study: 15-20 h before application

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
- Concentration in vehicle: 50%
- Application volume: 10 mL/kg
- Concentration of vehicle: 0.5%
Doses:
5000 mg/kg
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 weighing: day before application, day 2, 7, 13
- Frequency of observations: 1 h, 1, 2, 7, 14 days
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:
NA
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality
Clinical signs:
other: Red skin, scaly coat and hair loss were observed.
Gross pathology:
No adverse effects observed

Any other information on results incl. tables

Table 1: Bodys weight development

Day Mean body weight [g]
male  female
0 230 180
2-4 235 192
7 281 203
14 302 213

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on this study, the acute oral LD50 (gavage) in male/female rat is >5000 mg/kg bw.
Executive summary:

In an acute oral toxicity study, groups of fasted Sprague-Dawley rats (5/sex) were given a single oral dose of the test item at a dose of 5000 mg/kg bw and observed for 14 days.

 

Oral LD50 =  >5000 mg/kg bw

No mortalities and no gross pathological signs have been observed during the study. Symptoms of red skin, scaly coat and hair loss were observed.

Based on these results, the test item is not considered to be classified as acute toxic according to CLP criteria.