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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
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:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: acute toxicity procedure not further specified
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

1
Reference substance name:
not applicable being a mixture
IUPAC Name:
not applicable being a mixture
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Black powderwater solubility: 40g/lstorage: room temperatureexpiration date: March 2003

Test animals

Species:
rat
Strain:
other: Tif:RAIf
Sex:
male/female
Details on test animals or test system and environmental conditions:
Male and female rats (7 to 8 weeks old) raised on the premises were used for these experiments.. They were kept at a room temperature of 22 +/- 2° C, at a relative humidity of 55 +/- 10 % and on a 10 hours light cycle day. They received ad libitum rat food -NAFAG, Gossau SG - and water. Prior to treatment the animals were adapted to the laboratories for a minimum of 4 days. Bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days.During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages (type 3), individually marked with picricacid.

Administration / exposure

Route of administration:
oral: gavage
Details on oral exposure:
Animals were fasted overnight and gavaged once
Doses:
4000,5000,6000 and 8000 mg/kg
No. of animals per sex per dose:
5 males and 5 females per dose

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 8 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 6 000 - < 8 000 mg/kg bw
Based on:
test mat.
Mortality:
Mortality was observed on 2 females at the highest dose after 24h
Clinical signs:
Slght dispnea, exoftalmosis, ruffled fur, diarrohea, hunched position were observed that however stopped at day 8 of observation period for the 4000, 5000, 6000 mg/kg. At 8000 mg/kg the effects were stronger and sedation appeared, however these effects stopped at day 8.
Body weight:
No test item effect related to bodyweights was observed
Gross pathology:
No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:
other: not classified, Regulation 1272/2008
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test item was tested for acute toxicity. Under the experimental conditions the LD50 > 8000 mg/kg.
Executive summary:

The test item was tested for acute toxicity. Groups of five males and five females were gavaged once at 4000, 5000, 6000 and 8000 mg/kg and observed for 14 days for death, clinical signs and gross patology. Under the experimental conditions the LD50 > 8000 mg/kg.