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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
Study period:
1976
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
None
GLP compliance:
not specified
Test type:
fixed dose procedure

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)
EC Number:
257-827-7
EC Name:
Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)
Cas Number:
52301-70-9
Molecular formula:
C40H40N12O20S6.6Na
IUPAC Name:
hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Age at study initiation: 7 weeks
- Weight at study initiation: 220 g (males) and 166 g (females)
- Diet (e.g. ad libitum): Dakes special diet added with Vitamin E ad libitum
- Water (e.g. ad libitum): water was available at all times

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C (+/- 2°C)
- Photoperiod (hrs dark / hrs light): 12 hours artificial light and 12 hours darkness in each 24 hour period.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.
Doses:
A 25 % w/v solution of the compound in tap water was administered as a single dose by gavage to rats which had been fasted for 18 hours, at a rate of 20 ml/kg. (equivalent to 5 g/kg of compound).
No. of animals per sex per dose:
Ten rats (5 M + 5 F) were used for the study.
Control animals:
no
Details on study design:
None
Statistics:
None

Results and discussion

Preliminary study:
None
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality observed.
Clinical signs:
No clinical symptoms were recorded and no deaths occurred during the 14-day observation period.
Body weight:
None
Gross pathology:
At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
other: Not classified as toxic according to the CLP Regulation (EC) No.1272/2008
Conclusions:
The acute oral median lethal dose (LD50) of the substance in rats is greater than 5000 mg/kg body weight.
Executive summary:

The test was performed to determine the acute oral toxicity of the substance according to the equivalent or similar OECD guideline 401 (Acute Oral Toxicity). It was tested on rats which were 6 to 7 weeks old and weighed about 166 to 220 g. No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen. In conclusion, the acute oral LD50 of the substance in rats of both sexes, observed over a period of 14 days is greater than 5000 mg/kg.