1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from authoritative database

Data source

Reference

Reference Type:

review article or handbook

Title:

Acute dermal toxicity study of the test chemical

Author:

Sustainability Support Services (Europe) AB

Year:

2019

Bibliographic source:

WoE report, Sustainability Support Services (Europe) AB, 2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

Acute dermal toxicity study was performed to determine the toxic nature of the test chemical

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts

EC Number:

305-897-5

EC Name:

1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts

Cas Number:

95193-83-2

Molecular formula:

C18H11NO5S to C18H8NO11S3.3Na

IUPAC Name:

trisodium hydrogen bis(2-(1,3-dioxo-5-sulfonato-2,3-dihydro-1H-inden-2-yl)quinoline-8-sulfonate)

Details on test material:

- Name of the test chemical: 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts
- Molecular formula: C18H9NNa2O8S2
- Substance type: Organic

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Type of coverage:

not specified

Vehicle:

not specified

Details on dermal exposure:

No data

Duration of exposure:

14 days

Doses:

2. 2000 mg/Kg bw
3. 5000 mg/Kg

No. of animals per sex per dose:

No data

Control animals:

not specified

Details on study design:

2. - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, gross-pathology

3. - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data
- Other examinations performed: No data

Statistics:

No data

Results and discussion

Preliminary study:

No data

Effect levels

Effect levels 1

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed at the mentioned dose

Remarks:

2

Effect levels 2

Sex:

not specified

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50% mortality was observed at the mentioned dose

Remarks:

3

Mortality:

2. No mortality was observed at 2000 mg/Kg bw
3. 50% mortality was observed at approximately 5000 mg/Kg bw

Clinical signs:

other: 2. GASTROINTESTINAL: Hypermotility, diarrhea 3. No data

Gross pathology:

2. LIVER: Other changes;
KIDNEY, URETER, AND BLADDER: Other changes;
3. No data

Other findings:

No data

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The acute dermal median lethal dose (LD50) for the test chemical using rabbits is considered to be > 2000 mg/Kg bw.

Executive summary:

Data available for the various test chemicals was reviewed to determine the toxic nature of the test chemical. The studies are as mentioned below:

Acute dermal toxicity study was performed to determine the toxic nature of the test chemical. The study was performed using rabbits at dose of 2000 mg/Kg bw. The treated animals were observed for clinical signs and subjected to gross pathology. Hypermotility and diarrhea was noted in the gastrointestinal tract and few other changes were observed in liver, kidneys, ureter and bladder. No mortality was noted at dose of 2000 mg/Kg bw. Based on the results of the study, the acute dermal median lethal dose (LD50) for the test chemical using rabbits is considered to be >2000 mg/Kg bw.

Acute dermal toxicity study was performed to determine the toxic nature of the test chemical. The study was performed using rabbits at dose of 5000 mg/Kg bw. The treated animals were observed for mortality. 50% mortality was noted at approximately 5000 mg/Kg bw. Based on the results of the study, the acute dermal median lethal dose (LD50) for the test chemical using rabbits is considered to be approximately 5000 mg/Kg bw.

Based on the data available and applying the weight of evidence approach, the acute dermal median lethal dose (LD50) for the test chemical using rabbits is considered to be > 2000 mg/Kg bw.