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Administrative data

Description of key information

acute oral toxicity LD 50 = 9370 mg/kg bw
acute dermal toxicity LD 50 = 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Sex:
male/female
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
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

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.

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
9 370 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Sex:
male/female
Type of coverage:
occlusive
Vehicle:
water
Duration of exposure:
The shaved back of animals was wiped by gauze soaked in acetone – ethanol (1:1), then by gauze soaked in saline. Relevant amount of the test sample was applied on the depilated area of skin, covered by mull, plastic foil and held in contact by technical tape. Then fixative bandage was put on. The bandage was overlapped by technical tape and fixed around the whole body so that the test sample is in contact with the skin and cannot be ingested. After 24 hours the bandage was removed.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females were tested.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

Toxicity of the test sample was established according to evaluation of mortality, clinical signs of intoxication, body weight increment, and pathological findings within 14-day test. No clinical signs of intoxication were observed after application of the test sample. No pathological-anatomical findings were recorded within necropsy.

The LD50 value is greater than 5000 mg/kg of body weight. The test sample, Direct black 112, is not absorbed through the skin.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 value is greater than 5000 mg/kg of body weight. The test sample, Direct black 112, is not absorbed through the skin.
Executive summary:

Direct black 112 was tested for the acute dermal toxicity. 5 males and 5 females of Wistar rats were tested at 5000 mg/kg bw. After 24 hr exposure, the toxicity was established according to evaluation of mortality, clinical signs of intoxication, body weight increment, and pathological findings within 14-day test. No clinical signs of intoxication were observed after application of the test sample. No pathological-anatomical findings were recorded within necropsy.

The LD50 value is greater than 5000 mg/kg of body weight. The test sample, Direct black 112, is not absorbed through the skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw

Additional information

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. 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.

LD 50 for males and females was calculated, 9370 mg/kg bw.

Direct black 112 was tested for the acute dermal toxicity. 5 males and 5 females of Wistar rats were tested at 5000 mg/kg bw. After 24 hr exposure, the toxicity was established according to evaluation of mortality, clinical signs of intoxication, body weight increment, and pathological findings within 14-day test. No clinical signs of intoxication were observed after application of the test sample. No pathological-anatomical findings were recorded within necropsy.

The LD50 value is greater than 5000 mg/kg of body weight. The test sample, Direct black 112, is not absorbed through the skin.

Justification for classification or non-classification

Based on the available data, the substance is not classified for acute dermal and oral toxicity according to CLP regulation 1272/2008.