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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:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
non GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Trisodium 1-amino-4-[[3-[[4-chloro-6-[(sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
EC Number:
276-481-8
EC Name:
Trisodium 1-amino-4-[[3-[[4-chloro-6-[(sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Cas Number:
72214-18-7
Molecular formula:
C32H26ClN7O11S3.3Na
IUPAC Name:
trisodium 1-amino-4-[[3-[[4-chloro-6-[(sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Test material form:
other: solid
Details on test material:
None
Specific details on test material used for the study:
Code No: FAT 41001/D
Batch No: EN 94060.32
Description: solid
Contents of active ingredient: 78.8 %
Test Article Received: December 6, 1983

Test animals

Species:
rat
Strain:
other: Tif:RAIf(SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland.
- Age at study initiation: 7 - 8 weeks.
- Weight at study initiation: 178 - 219 g.
- Housing: The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Société Parisienne des sciures, Pantin).
- Diet (e.g. ad libitum): Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), ad libitum.
- Water (e.g. ad libitum): ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%):55 ± 15
- Air changes (per hr): approximately 15 air changes/h.
- Photoperiod (hrs dark / hrs light): 12 hours light/day.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Distilled water containing 0.5 % carboxymethylcellulose and 0.1 % polysorbate 80
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 ml/kg bw, resp. 10
- Amount of vehicle (if gavage): 5000, 2000 mg/kg bw.

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw
Doses:
2000 and 5000 mg/kg bw.
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: on days 1, 7, 14 and at death.
- Necropsy of survivors performed: yes.
- Other examinations performed: mortality, signs and symptoms, body weight, necropsies.
Statistics:
From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95 % confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)

Results and discussion

Preliminary study:
None
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Non toxic
Mortality:
No mortality occured at 2000 mg/kg (1 male died due to intratracheal intubation).
All animals were found dead at 5000 mg/kg bw.
Clinical signs:
Dyspnoea, exophthalmos, ruffled fur and curved body position were seen, being common symptoms in acute tests. In addition, diarrhea was noted during the first two days as well as a blue staining of the eyes and extremities.
Body weight:
No significant changes
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 value in rats via oral administration of test substance FAT 41001/D was found to be greater than 2000 mg/kg bw.
Executive summary:

A study was conducted to assess acute oral toxicity of FAT 41001/D according to OECD Guideline 401 (Acute Oral Toxicity) guideline. The test substance was of 78.8% purity. The test substance was administered orally suspended in distilled water containing 0.5 % carboxymethylcellulose and 0.1 % polysorbate 80 (prepared by Pharmaceutical Division, Ciba-Geigy Ltd.). Mortality, body weight, signs and sypmtoms of toxicity were observed. Necropsy was conducted on dying animals or survivors at the end of observation period.

Symptoms:

No deaths were observed in both male and female groups at 2000 mg/kg bw. At 5000 mg/kg bw, all animals were found dead with blue stained carcass. No change in body weight. Symptoms of dyspnoea, ruffled fur, diarrhoea and hunched posture was observed. All the symptoms disappeared within 10 days of exposure period.

The LD50 value in rats via oral administration of test substance FAT 41001/D was found to be greater than 2000 mg/kg bw.