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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
comparable to guideline study with acceptable restrictions
Remarks:
(TS purity not specified; 7-day observation period; body weights determined only at study start; no GLP)

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)
Deviations:
yes
Remarks:
7-day observation period; body weights determined only at study start
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-[2-(4-chlorophenoxy)-5-(trifluoromethyl)phenyl]benzamide]
EC Number:
279-356-6
EC Name:
3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-[2-(4-chlorophenoxy)-5-(trifluoromethyl)phenyl]benzamide]
Cas Number:
79953-85-8
Molecular formula:
C55H37Cl5F6N8O8
IUPAC Name:
3,3'-{(2-chloro-5-methyl-1,4-phenylene)bis[imino(1,3-dioxobutane-2,1-diyl)diazene-2,1-diyl]}bis{4-chloro-N-[2-(4-chlorophenoxy)-5-(trifluoromethyl)phenyl]benzamide}
Test material form:
solid

Test animals

Species:
rat
Strain:
other: albino rats
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Tif. RAI SPF own breeeding rats from Ciba-Geigy Ltd.
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 160-180 g
- Fasting period before study: overnight prior to dosing
- Housing: caged in groups of 5 in Macrolon cages type 3
- Diet: Rat food, NAFAG, Gossau, SG, rat food; ad libitum
- Water: drinking water; ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS (the animal room was air conditioned)
- Temperature (°C): 22 ± 1
- Humidity (%): approx. 50
- Air changes (per hr): approx. 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
2%
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30% (w/v)

DOSAGE PREPARATION:
The test substance was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 30 % with CMC (2%). Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
Doses:
6000 and 7750 mg/kg bw (it was not possible to evaluate higher dose level)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: daily for mortality and clinical signs of toxicity; body weights were not determined
- Necropsy of survivors performed: yes; the animals were killed and autopsied after an observation period.
Statistics:
None conducted

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 750 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed up to this dose level
Mortality:
No mortality occurred
Clinical signs:
other: Within 2 hours after treatment the rats of both dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. The animals recovered within 4 to 6 days.
Gross pathology:
No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met