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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:
1989-04-01 to 1989-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987-02-24
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
1984-09
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of Amines, C12-14-tert-alkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]cobaltate(1-) and sodium bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]cobaltate(1-)
EC Number:
916-868-7
Molecular formula:
C32H22CoN10O8.C10-14H21-29NH2 and C32H22CoN10O8.Na
IUPAC Name:
Reaction mass of Amines, C12-14-tert-alkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]cobaltate(1-) and sodium bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]cobaltate(1-)
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Batch No. of test material: 216096.89

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At 20 °C in the dark
- Stability of the test substance in the vehicle: At least 48 hours in carboxymethylcellulose

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The formulations were prepared immediately prior to dosing. The test article was weighed into a glass flask on an analytical balance and the vehicle (w/w) was added. Homogeneity of the test article in vehicle was obtained by a homogeniser, Concentration of test article in vehicle was varied to allow constant dosage volume in terms of ml/kg body weight.

OTHER SPECIFICS: Orange, solid

Test animals

Species:
rat
Strain:
Wistar
Remarks:
outbred, SPF-Quality
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: ~ 8 weeks
- Weight at study initiation: ♂: 267 - 305 g; ♀: 177 - 200 g
- Fasting period before study: Food was withheld overnight prior to dosing until ~ 3 - 4 hours after administration of the test article.
- Housing: Housed in groups of five per sex in polycarbonate cages.
- Diet: standard pelleted laboratory animal diet (RMH-B from Hope Farms, Woerden, The Netherlands), ad libitum
- Water. tap-water, ad libitum
- Acclimation period: Five days under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 7.5 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
methylcellulose
Details on oral exposure:
VEHICLE
- Amount of vehicle: 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION: The test article was weighed into a glass flask on an analytical balance and the vehicle (w/w) was added.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observation at periodic intervals on the day of dosing (day 1) and twice daily thereafter for at least 14 days. Body weights at test days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes, all animals were necropsied and descriptions of all macroscopic abnormalities were recorded. All animals surviving to the end of the observation period were sacrificed by carbon dioxide asphyxiation and subjected to necropsy.
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
Diarrhoea was noted in all animals on the day of treatment during the final observation (4.15 hours after dosing). No other clinical signs of toxicity or behavioural changes were seen over the 15 day observation period.
Body weight:
All animals showed normal body weight gain during the study period.
Gross pathology:
Macroscopic examination of all animals at termination did not reveal any abnormalities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met