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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:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 95.2%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Doses:
6310 mg/kg bw; 7943 mg/kg bw; 10000 mg/kg bw; 12590 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females per each concentration

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
9 370 mg/kg bw
Based on:
test mat.
95% CL:
> 8 730 - < 10 062

Any other information on results incl. tables

Mortality

 

Number of dead animals

 

Does (mg/kg)

males

females

%

6310

0

0

0

7943

3

0

30

10000

2

3

50

12590

5

5

100

Higher percentage of mortality was recorded in males.

Dose level 6310 mg/kg bw

Males: no clinical signs of intoxication were observed, all animals survived.

Females: no clinical signs of intoxication were observed, all animals survived.

Dose level 7943 mg/kg bw

Males: 3 animals died till the 2ndday; diarrhea of all animals was recorded 3 hours after application. Survived animals were without clinical signs of intoxication till four days after application.

Females: Diarrhoea was observed in all animals; all animals were without clinical signs of intoxication till four days and survived.

Dose level 10000 mg/kg bw

Males: Disarrhoea in all animals, somnolence in two animals were recorded. All animals were cyanotic. Two animals died till the 2ndday after application. Survived animals were without clinical signs of intoxication till three days after application.

Females: The same clinical signs as in males were observed in females, somnolence was observed in one female, 3 females died till the 2ndday after application. Survived animals were without clinical signs of intoxication till tree days after application.

Dose at 12590 mg/kg bw

Males: The first animal died 3 hrs after application; next three died in the 2ndday after application and one male died the 3rdday.

The clinical signs of intoxication were observed 3 hrs after application: piloerction, anemic mucous membranes and somnolence.

Females: All animals died till the 2ndday after application, the same clinical signs as in males were observed and also red discharge from nostrils was recorded.

Overall

Catarrh of stomach was recorded in all dead animals.

No pathological findings were recorded in sacrificed animals at the end of test.

Clinical signs of intoxication in lethal dose level are anemia, cyanosis followed by somnolence.

The test sample affected digestive tract – diarrhea, catarrh of stomach and intestine were recorded. These findings are reversible till 14 days.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 for males and females was calculated, 9370 mg/kg bw.
Executive summary:

Direct black 112 was tested for the acute oral toxicity. 5 Males and 5 females of Wistar rats were tested per concentrations, 6310 mg/kg bw, 7943 mg/kg bw, 10000 mg/kg bw and 12590 mg/kg bw. LD 50 for males and females was calculated, 9370 mg/kg bw.

Catarrh of stomach was recorded in all dead animals.

No pathological findings were recorded in sacrificed animals at the end of test.

Clinical signs of intoxication in lethal dose level are anemia, cyanosis followed by somnolence.

The test sample affected digestive tract – diarrhea, catarrh of stomach and intestine were recorded. These findings are reversible till 14 days.