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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods 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:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
None
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
[2-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulphophenyl)-1H-pyrazol-4-yl]azo]benzoato(3-)]chromium
EC Number:
276-702-8
EC Name:
[2-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulphophenyl)-1H-pyrazol-4-yl]azo]benzoato(3-)]chromium
Cas Number:
72496-90-3
Molecular formula:
C17H11CrN4O6S
IUPAC Name:
[2-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulphophenyl)-1H-pyrazol-4-yl]azo]benzoato(3-)]chromium
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
None

Test animals

Species:
rat
Strain:
other: Tif. RAI rats
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 6 to 7 weeks old
- Weight at study initiation: 160 to 180 g
- Fasting period before study: 1 night before the test
- Housing: Macrolon cages type 3
- Diet: NAFAG, Gossau SG, rat food ad libitum
- Water: ad libitum

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
None
Doses:
2150, 3590, 4640, 6000, 7750 and 10000 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: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
The LD50 was calculated by probit analysis method (Goulden A., Methods of Statistical Analysis, John Wiley and Sons, 1960, 3rd printing, pages 404-408).

Results and discussion

Preliminary study:
None
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
6 213 mg/kg bw
Based on:
test mat.
Mortality:
Following mortalities were recorded: 1 male at 3590 mg/kg bw, 2 females at 4640 mg/kg bw, 1 male and 1 female at 6000 mg/kg bw, 3 males and 5 females at 7750 mg/kg bw, 5 males and 5 females at 10000 mg/kg bw.
Clinical signs:
Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased.The surviving animals had recovered within 7 to 8 days.
Body weight:
Not reported
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 median lethal dose (LD50) of compound FAT 20041/A in rats is 6213 mg/kg bw.
Executive summary:

The acute oral toxicity of FAT 20041/A was evaluated in male and female rats. The methodology used was similar to OECD Guideline 401. Groups of rats (5 males and 5 females in each group) were administered the test substance at 2150, 3590, 4640, 6000, 7750 and 10000 mg/kg bw and observed for 14 days. Following adminstration of the test substance, mortalities recorded were as follows: 1 male at 3590 mg/kg bw, 2 females at 4640 mg/kg bw, 1 male and 1 female at 6000 mg/kg bw, 3 males and 5 females at 7750 mg/kg bw, 5 males and 5 females at 10000 mg/kg bw. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 7 to 8 days. At autopsy no changes caused by the administration of FAT 20041/A were seen with found dead as well as surviving animals. In conclusion, the acute oral LD50 of FAT 20041/A in rats of both sexes observed over a period of 14 days is 6213 mg/kg bw.