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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
Study period:
From October 25 to November 15, 1978.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to internationally accepted testing guidelines, well documented and the results scientifically acceptable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

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:
The acute oral toxicity in rats of both sexes was tested administrating the test item by gavage at doses of 7000, 8000 and 10000 mg/kg bw. The observation period following administration was of 14 days.
GLP compliance:
no
Remarks:
pre GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium sodium 4,4'-bis[6-anilino-4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
EC Number:
275-031-8
EC Name:
Potassium sodium 4,4'-bis[6-anilino-4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
Cas Number:
70942-01-7
Molecular formula:
C40H44KN12NaO10S2
IUPAC Name:
potassium sodium 2,2'-ethene-1,2-diylbis[5-({4-anilino-6-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7 to 8 weeks old.
- Housing: housed in groups of 5 in Macrolon cages (type 3).
- Fasting period before study: animals fasted overnight.
- Diet: ad libitum rat food - NAFAG, Gossau SG.
- Water: ad libitum
- Acclimation period: minimum of 4 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod: 10 light cycle day.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Doses:
7000, 8500 and 10000 mg/kg
No. of animals per sex per dose:
5 males and 5 females per dose
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: recorded at day 1, 7 and 14.
- Necropsy of survivors performed: yes; the animals were submitted at random to a necropsy at the end of the observation period.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 200 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality occurred.
Clinical signs:
other: The rats in all dosage groups showed sedation, dyspnoea, exophthalmos, salivation and curved position; ruffled fur was observed at doses of 8500 and 10000 mg/kg bw. All symptoms were recovered within 10 days.
Gross pathology:
No substance related gross organ changes were seen.

Any other information on results incl. tables

Rate of deaths

Dose
mg/kg		 Sex Total
Number
animals
in group		 Total
Number
animals
dead		 Death
rate
percentage
7000 M 5 0 0
8500 M 5 0 0
10000 M 5 0 0
7000 F 5 0 0
8500 F 5 0 0
10000 F 5 0 0

Signs and symptoms, dose of 7000 mg/kg

Signs and symptoms hrs Days
1 2 4 6 24 2 3 4 5 6 7 8 9 10 11 12 13 14
Sedation + + + +
Dyspnoea + + + + + + + + + +
Dacryorrhoea
Chromodacryorrhoea
Rinorrhoea
Epistaxis
Exophthalmos + + + + +
Salivation + + + + + + + + + +
Ruffled fur
Pallor
Cyanosis
Diarrhoea
Body position (ventral)
Body position (lateral)
Body position (curved) + + + + + + + + + +
Ataxia
Trismus
Tremor
Tonic clonic muscle spasms
Convulsions

Signs and symptoms, dose of 8500 mg/kg

Signs and symptoms hrs Days
1 2 4 6 24 2 3 4 5 6 7 8 9 10 11 12 13 14
Sedation + + + +
Dyspnoea + + + + + + + + + +
Dacryorrhoea
Chromodacryorrhoea
Rinorrhoea
Epistaxis
Exophthalmos + + + + +
Salivation
Ruffled fur + + + + + + + + + +
Pallor
Cyanosis
Diarrhoea
Body position (ventral)
Body position (lateral)
Body position (curved) + + + + + + + + + +
Ataxia
Trismus
Tremor
Tonic clonic muscle spasms
Convulsions

Signs and symptoms, dose of 10000 mg/kg

Signs and symptoms hrs Days
1 2 4 6 24 2 3 4 5 6 7 8 9 10 11 12 13 14
Sedation + + + + + +
Dyspnoea + + + + + + + +
Dacryorrhoea
Chromodacryorrhoea
Rinorrhoea
Epistaxis
Exophthalmos + + + + +
Salivation
Ruffled fur + + + + + + + + +
Pallor
Cyanosis
Diarrhoea
Body position (ventral)
Body position (lateral)
Body position (curved) + + + + + + + + +
Ataxia
Trismus
Tremor
Tonic clonic muscle spasms
Convulsions

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU
Conclusions:
LD50 > 2200 mg/kg bw
Executive summary:

Method

The acute oral toxicity in rats of both sexes was tested administrating the test item by gavage at doses of 7000, 8000 and 10000 mg/kg bw. The observation period following administration was of 14 days.

Results

LD50 > 2200 mg/kg bw based on active ingredient.