Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

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 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-[[5-acetamide-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-ethoxyphenyl]imino]diethyl diacetate
EC Number:
235-475-5
EC Name:
2,2'-[[5-acetamide-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-ethoxyphenyl]imino]diethyl diacetate
Cas Number:
12239-34-8
Molecular formula:
C24H27BrN6O10
IUPAC Name:
({2-acetamido-3-[(2-bromo-4,6-dinitrophenyl)diazenyl]-5-ethoxyphenyl}imino)diethane-2,1-diyl diacetate
Test material form:
liquid
Details on test material:
Mablue S-2GLfl

Test animals

Species:
rat
Strain:
other: CFY
Sex:
male
Details on test animals or test system and environmental conditions:
Weight range: 244 to 264 g

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10% of the total body surface
- Type of wrap if used: aluminium foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm (40-50°C) dilute soap solution, rinsing in clean warm water
- Time after start of exposure: 24 h

Duration of exposure:
24 hours
Doses:
5 mL/kg bw
No. of animals per sex per dose:
10 male rats
Control animals:
yes
Remarks:
treated with water
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations: clinical signs daily; body weight weekly
- Necropsy of survivors performed: yes
Statistics:
NA

Results and discussion

Preliminary study:
NA
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Mortality:
no deaths
Clinical signs:
other: slight lethargy and piloerection
Gross pathology:
congestion of the lungs ond pale or uneven col.ouration of the liver and kidneys. Five rats had haemorrhage of.the subcutaneous blood vessels of the treated areas.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, acute dermal LD50 of the test substance in rats was determined to be greater than 5 mL/kg bw.
Executive summary:

A study was conducted to determine the acute dermal toxicity of the test substance according to a method equivalent to OECD Guideline 402. No mortality was observed in the treated rats. According to the study conditions, the acute dermal LD50 of the test substance was determined to be greater than 5 mL/kg bw (Davies, 1974).