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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:
July 7, 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to 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)
GLP compliance:
no
Remarks:
pre GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
EC Number:
267-224-0
EC Name:
Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Cas Number:
67827-60-5
Molecular formula:
C31H26N3O6S.Na
IUPAC Name:
sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Test material form:
not specified

Test animals

Species:
rat
Strain:
other: TIF RAIF
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: the mean initial body weight of the groups ranged from 80 to 110 grams
- Diet: standard diet of pellets - No. 890, Nafag Gossau SG. Fasted overnight before treatment
- Water: ad libitum
- Acclimation period: minimum 5 days
- Housing: During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1°C
- Humidity (%): 55*5 %
- Photoperiod (hrs dark / hrs light): 14 hours light cycle day

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
Concentrations of substance in vehicle:
- 10 % (1000mg/kg)
- 30 % (3000mg/kg)
- 20 % (8000mg/kg)
- 25 % (10000mg/kg)
- 25 % (15000mg/kg)
Doses:
1000, 3000, 5000, 8000, 10000, 15000 (mg/kg)
No. of animals per sex per dose:
5 per sex per dose
Control animals:
no
Details on study design:
Physical condition and rate of death were monitored throughout the whole observation period.
Post observation period = 15 days

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 8 850 mg/kg bw
Based on:
test mat.
95% CL:
> 7 960 - < 9 900
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 5 664 mg/kg bw
Based on:
act. ingr.
Mortality:
1000, 3000 mg/Kg bw: no death occurs
8000 mg/Kg bw: 1 female died in a day
10000 mg/Kg bw: 4 male and 5 female died in a day
15000 mg/Kg bw: all animals died in a day
Clinical signs:
1000 mg/Kg bw: none
3000 mg/Kg bw: diarrhea, after 24 hours no symptoms
8000 mg/Kg bw: ditto, reduction in spontaneous motility, ataxia, ventricumbency, muscular hypotonia, hypoventilation. After 2 days no symptoms
10000 mg/Kg bw: ditto
15000 mg/Kg bw: ditto, cyanosis. All animals died within 6 hours in respiratory failure
Body weight:
1000 mg/Kg bw: 80 g ->177 g after 15 days
3000 mg/Kg bw: 80 g ->175 g after 15 days
8000 mg/Kg bw: 105 g ->196 g after 15 days
10000 mg/Kg bw: 100 g ->190 g after 15 days
15000 mg/Kg bw: 110 g ->died after 15 days

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 = 8850 mg/Kg bw
Executive summary:

Method:

Similar to OECD guideline 401.

Observations:

At a concentrations of 8000 mg/Kg a death occured after a day. At 10000 mg/Kg bw nine animals death after a day and at 15000

mg/Kg bw ten animals death after a day.

All animals died in respiratory failure.

Results:

LD50 = 8850 mg/Kg bw (LD50 = 5664 mg/kg bw based on active ingredient).