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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Test substance was administered by oral intubation and animals were observed for 14 days.
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
hexasodium 4-[3-(2-bromoprop-2-enamido)benzamido]-6-[(E)-2-[5-(2,3-dibromopropanamido)-2-sulfophenyl]diazen-1-yl]-5-hydroxynaphthalene-1,7-disulfonate 6-[(E)-2-[5-(2-bromoprop-2-enamido)-2-sulfophenyl]diazen-1-yl]-4-[3-(2-bromoprop-2-enamido)benzamido]-5-hydroxynaphthalene-1,7-disulfonate
EC Number:
941-899-8
Cas Number:
1625603-53-3
Molecular formula:
C29H18Br2N5Na3O13S3 . C29H19Br3N5Na3O13S3
IUPAC Name:
hexasodium 4-[3-(2-bromoprop-2-enamido)benzamido]-6-[(E)-2-[5-(2,3-dibromopropanamido)-2-sulfophenyl]diazen-1-yl]-5-hydroxynaphthalene-1,7-disulfonate 6-[(E)-2-[5-(2-bromoprop-2-enamido)-2-sulfophenyl]diazen-1-yl]-4-[3-(2-bromoprop-2-enamido)benzamido]-5-hydroxynaphthalene-1,7-disulfonate
Test material form:
other: solid
Specific details on test material used for the study:
None

Test animals

Species:
rat
Strain:
other: RAI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: In house breeding
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 160 - 180 g
- Fasting period before study: over night before starting the study
- Housing: The males and females were segregated and housed in Macrolon cages (Type 3) in groups of 5.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-1
- Humidity (%): 50

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
FAT 40065/A was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 30 % with polyethylene glycol (PEG 400) 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.
Doses:
4640, 5000, 6000 and 7750 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 1hr, 24 hr, 48 hr, 7 days and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology.
Statistics:
None applied

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
6 528 mg/kg bw
Based on:
test mat.
Remarks on result:
other: The LD50 was calculated by probit analysis method. 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.
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
4 640 mg/kg bw
Based on:
test mat.
Remarks on result:
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.
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
6 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 3 animals died at the end of 14 days (LD30)
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
7 750 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 9 animals died at the end of 14 days (LD90)
Mortality:
3 (out of 10) and 9 (out of 10) animals died over the observation period of 14 days when treated with 6000 and 7750 mg/kg bw, respectively. No mortality was observed in animals treated with 4640 and 5000 mg/kg bw.
Clinical signs:
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.
Body weight:
Not observed
Gross pathology:
No substance-related gross organ changes were seen.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 of FAT 40065/A in rats of both sexes observed over a period of 14 days is 6528 (6049-7045)* mg/kg bw.
Executive summary:

The test compound FAT 40065/A was tested on 40 Tif. RAI rats (20 males/ 20 females), bred under SPF conditions to determine LD50 value at the end of 14 days.

At the beginning of the test, the animals 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 ad libitum. The rats were starved during one night before starting the treatment.

FAT 40065/A was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 30 % with polyethylene glycol (PEG 400) 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.

3 (out of 10) and 9 (out of 10) animals died over the observation period of 14 days when treated with 6000 and 7750 mg/kg bw, respectively. No mortality was observed in animals treated with 4640 and 5000 mg/kg bw.

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 8 days. They were killed and autopsied after an observation period of 14 days. No substance-related gross organ changes were seen.

Based on the findings of the study, the acute oral LD50 of FAT 40065/A in rats of both sexes observed over a period of 14 days is 6528 (6049-7045) mg/kg which was calculated by probit analysis method.