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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:
1980-1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[3-[(1-oxopropyl)amino]phenyl]amino]anthracene-2-sulphonate
EC Number:
289-550-2
EC Name:
Sodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[3-[(1-oxopropyl)amino]phenyl]amino]anthracene-2-sulphonate
Cas Number:
89923-62-6
Molecular formula:
C23H19N3O6S.Na
IUPAC Name:
sodium 1-amino-9,10-dioxo-4-[(3-propanamidophenyl)amino]-9,10-dihydroanthracene-2-sulfonate
Test material form:
other: solid
Details on test material:
None

Test animals

Species:
rat
Strain:
other: 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: During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages (type 3), individually marked with picric acid.
- Diet: ad libitum (rat food - NAFAG, Gossau SG)
- Water: ad libitum
- Acclimation period: Prior to treatment the animals were adapted to our laboratories for a minimum of 4 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod:10 hours light cycle day.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
VEHICLE
Polyethylene glycol, Fluka AG Buchs SG, Art. 81170.

MAXIMUM DOSE VOLUME APPLIED: 10, 20 ml/kg body-weight

DOSAGE PREPARATION:
FAT 20242/A was diluted to achieve the corresponding dosage level. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Animals fasted overnight were treated by single oral intubation.

Doses:
1000, 2500, 5000 and 7000 mg/kg bw
No. of animals per sex per dose:
1000 mg/kg: 5 males and 5 females
2500 mg/kg: 10 males and 10 females
5000 mg/kg: 10 males and 10 females
7000 mg/kg: 10 males and 10 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations: daily for mortality and clinical signs.
- Weighing: day 1, day 7 and day 14.
- Necropsy of survivors performed: yes.
Statistics:
None

Results and discussion

Preliminary study:
None
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
Males (rate of deaths):
1000 mg/kg: 0 %
2500 mg/kg: 10%
5000 mg/kg: 30%
7000 mg/kg: 0%

Females (rate of deaths)
1000 mg/kg: 0 %
2500 mg/kg: 20%
5000 mg/kg: 80%
7000 mg/kg: 10%
Clinical signs:
other: Sedation, dyspnoea, exophthalmos, ruffled fur, diarrhoea, body position (ventral, lateral and curved) and convulsions were the clinical signs observed. The clinical signs reversed by day 8.
Gross pathology:
No compound related gross organ changes were observed.
Other findings:
None

Any other information on results incl. tables

Signs and symptoms at 1000 mg/kg bw:

               Hours                                      Days

Signs and symptoms

  1  2  3  5  24  2  3  4  5  6  7  8  9  10  11 12  13   14
 Sedation  + +  +  +  +  +                         
 Dyspnoea  + +  +  +  +  +  +  +  +  +  +               
 Exophthalmos          + +  +  +  +  +  +               
 Ruffled fur  ++ ++  ++  ++  ++  +  +  +  +  +  +               
 Diarrhoea        + +                           
 Body position curved  + +  +  +  +  +  +  +  +                   

Signs and symptoms at 2500 mg/kg:

               Hours                                     Days 
 Signs and symptoms  1 2  3  5  24  2  3  4  5  6  7  8  9  10  11  12  13  14 
 Sedation  + +  +  +  +  +                         
 Dyspnoea  + +  +  +  +  +  +  +  +  +  +               
 Exophthalmos          + +  +  +  +  +                 
 Ruffled fur  ++ ++  ++  ++ ++  +  +  +   + +  +               
Diarrhoea    + +  +  +  +                         
Body position curved

  +  +  + +  +  +  +  +  +  +  +               

Signs and symptoms at 5000 mg/kg bw:

Signs and symptoms              Hours                                     Days 
   1 2  3  5  24  2  3  4  5  6  7  8  9  10  11  12  13  14 
 Sedation  + +  +  +  +                           
 Dyspnoea  +  + +  +  +  +  +  +  +  +  +               
 Exophthalmos          + +  +  +  +                   
 Ruffled fur  ++  ++  ++ ++  ++  ++  ++  ++  ++   + +               
 Diarrhoea    ++ ++  ++  +  +  +  +                     
 Body position ventral    + +  +  +                           
 Body position lateral    + +  +  +                           
 Body position curved  + +  +  +  +  +  +  +  +  +  +               
 Convulsions    ++ +  +                             

Signs and symptoms at 7000 mg/kg bw:

 Signs and symptoms              hours                                     Days 
   1 2  3  5  24  2  3  4  5  6  7  8  9  10  11  12  13  14 
 Sedation  ++  ++ ++  ++  +  +                         
 Dyspnoea  + +  ++  ++  +  +  +  +  +  +  +               
 Exophthalmos          + +  +  +  +  +                 
 Ruffled fur  ++  ++  ++  ++  ++  ++  ++  ++ +  +  +               
 Diarrhoea  +  ++ ++  ++  +                           
 Body position ventral    + +  +  +                           
 Body position lateral    +  +  +  +                          
 Body position curved  +  +  +  +  + +  +  +  +  +  +               
 Convulsions    + +  +  +                           

BODY WEIGHT CHANGE:

              Dose (mg/kg bw)
     1000 2500  5000  7000 
 Day 1 (males)   Mean bodyweight/SD (g)  184 /2.8  176 /2.3  184 /1.5  210 /10.1
 Day 1 (females)   Mean bodyweight/SD (g)  170 /2.5  167 /6.9  171 /1.4  182 /5.6
 Day 7 (males)   Mean bodyweight/SD (g)  243 /6.3  237 /2.7  228 /4.0  258 /8.2
 Day 7 (females)   Mean bodyweight/SD (g)  204 /4.1  205 /5.0  -  207 /3.5
 Day 14 (males)   Mean bodyweight/SD (g)  275 /5.1  292 /2.6  276 /3.5  298 /9.8
 Day 14 (females)   Mean bodyweight/SD (g)  227 /9.3 192 /25.9   - 232 /5.1 

The surviving animals recovered within 7 days. All rats were submitted to a necropsy whenever they died, survivors at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The acute oral LD50 of FAT 20242/A in rats of both sexes observed over a period of 14 days is >2500 mg/kg bw.
Executive summary:

A study was carried out for the determination of the acute oral LD50 of FAT 20242/A using 80 Tif. RAI rats by following the methodology similar to OECD TG 401. Before administration by oral intubation, FAT 20242/A was suspended in polyethylene glycol (PEG 400). The test material was administered at 1000, 2500, 5000 and 7000 mg/kg bw respectively.

At 1000 mg/kg bw, no mortality was seen. However, 15, 55 and 50 % mortality was seen at 2500, 5000 and 7000 mg/kg bw, respectively. Sedation, dyspnoea, exophthalmos, ruffled fur, diarrhoea, body position (ventral, lateral and curved) and convulsions were the clinical signs observed. The clinical signs reversed by day 8. At necropsy, no substance related gross organ changes were seen. In conclusion, the acute oral LD50 of FAT 20242/A in rats of both sexes observed over a period of 14 days is greater than 2500 mg/kg bw.