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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:
14 March 1974
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:
1974
Report date:
1974

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-4-[[3,5-bis[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
EC Number:
279-365-5
EC Name:
Sodium 1-amino-4-[[3,5-bis[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Cas Number:
80010-51-1
Molecular formula:
C29H28Cl2N4O7S.Na
IUPAC Name:
sodium 1-amino-4-[(3,5-bis{[(chloroacetyl)amino]methyl}-2,4,6-trimethylphenyl)amino]-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
FAT 210 36/A
Specific details on test material used for the study:
Name: 21036 / A
Purity: 79.9 %

Test animals

Species:
rat
Strain:
other: Tif. RAI
Sex:
male/female
Details on test animals or test system and environmental conditions:
The compound was tested on 40 Tif. .RAI rats (20 males/20 females), bred under SPF conditions in our own breeding unit. They were 6 to 7 weeks old and weighed 160 to 180 g. The males and females were segregated and housed in Macrolon cages (Type 3) in groups of 5 in a room kept at a constant temperature of 22 ± 1 °C and a relative humidity of approximately 50 %. They received water and food (NAFAG, Gossau SG, rat food) ad libitum. The rats were starved during one night before starting the treatment.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
1000, 3170, 4640 and 6000 mg/kg
No. of animals per sex per dose:
5 male and 5 females
Control animals:
no
Details on study design:
FAT 21036/A was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 10 and 30 % with carboxymethylcellulose 2 % and administered by oral intubation. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 000 mg/kg bw
Based on:
test mat.
Mortality:
One animal was found dead in 6000 mg/kg group.
Clinical signs:
other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 4 to 6 days
Gross pathology:
No substance related gross organ changes were seen.
Other findings:
No further abnormalities reported.

Any other information on results incl. tables

Mortality:

Dose mg/kg

Concentration % of formulation

No of Animals

Died within

     m  f  m 2hr f 1hr  m 24 hrs  f24 hrs  m 48 hrs  f 48 hrs  m 7 d f  7 d m 14 d  f 14 d
 1000  10  5  5  0  0  0  0  0  0  0  0  0
 3170  30  5  5  0  0  0  0  0  0  0  0

 0

 4640

 30

 5

 5

 0

0

0

0

 6000

 30

 5

 5

 0

 1

 0

1

 1

1

 1

 1

 1

 1

                  No higher dosed were possible                      

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 of FAT 21036/A in rats of both sexes observed over a period of 7 days is greater than 6000 mg/kg.
Executive summary:

The acute oral toxicity of FAT 21036/A was assessed using Tif. RAI rats in a study conducted using methodology similar to OECD Guideline 401. FAT 21036/A was suspended at 30 % with polyethylene glycol (PEG 400). The test material was administered at different doses (5 males and 5 females rats per dose): 1000, 3170, 4640 and 6000 mg/kg. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 4 to 6 days. No substance related gross organ changes were seen at the post mortem examination. In conclusion, the acute oral LD50 of FAT 21036/A in rats of both sexes observed over a period of 7 days is greater than 6000 mg/kg. The compound therefore is non-toxic to the rat by this route of administration.