3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate

Endpoint summary

Description of key information

The LD 50 of the test substance for the acute oral toxicity is greater than 2000 mg/kg bw.
The LD 50 of the test substance for the acute dermal toxicity is greater than 2000 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:

From April 10th to May 1st, 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

July 31st, 1992

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

February 24th, 1987

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

Stable in a 1:1 mixture of PEG/water for 48 hours

Species:

rat

Strain:

Wistar

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

other: bidistilled water:PEG 400 = 1:1

Details on oral exposure:

Dosage after 16 hours fasting, but free access to water. Food was provided approximately 3 hours after dosing.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male rats, 5 female rats

Control animals:

no

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

There were no deaths as a result of treatment with the test substance.

Clinical signs:

other: No clinical signs of toxicity were observed during the observation period.

Gross pathology:

No macroscopic findings were observed at necrospy.

The mean lethal dose of the test substance after single oral administration to rats of both sexes, observed for a period of 14 days, could not be estimated because LD50 > 2000 mg/Kg.

Interpretation of results:

other: not classified within the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 > 2000 mg/kg

Executive summary:

The acute toxicity of the test material was investigated following oral administration of a single dose to the rat, according to the OECD Guideline 401.

The test substance was administered to rats of both sexes by oral gavage, at a dose of 2000 mg/kg.
The following death rate was observed:
0% at 0 mg/kg (control group)
0% at 2000 mg/kg

No clinical signs of toxicity were observed during the observation period.

The acute oral LD50 of the test substance in rats of both sexes, observed over a period of 14 days, was estimated to be greater than 2000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

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:

From April 30th to May 21st, 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

February 24th, 1987

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

July 31st, 1992

GLP compliance:

yes (incl. QA statement)

Limit test:

yes

Specific details on test material used for the study:

Stable in a 1:1 mixture of PEG/water for 48 hours

Species:

rat

Strain:

Wistar

Sex:

male/female

Type of coverage:

semiocclusive

Vehicle:

other: other: bidistilled water:PEG 400 = 1:1

Details on dermal exposure:

Clipped area on the back of animals corresponding to ca. 10 % of the total body surface.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male rats, 5 female rats

Control animals:

no

Details on study design:

Observations up to day 15.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death occurred.

Clinical signs:

other: There were no clinical signs of sistemic toxicity.

Gross pathology:

No macroscopic findings were noted at necropsy.

Other findings:

After removal of the dressing on test day 2, a blue coloration of the skin was observed at the application site of all animals. The staining persisted until test day 7.

Interpretation of results:

other: Not classified within the CLP Regulation (EC 1272/2008).

Conclusions:

LD50 > 2000 mg/kg

Executive summary:

The acute toxicity of the test material was investigated following dermal administration of a single dose to the rat, according to the OECD Guideline 402. A single dose of 2000 mg/kg was administered to a group of 5 male and 5 female animals for 24 hours, under semiocclusive dressing. Animals were observed up to day 15. After 14 days, all animals were killed and subjected to necropsy examination.

No mortality occurred and no signs of toxicity were observed in male or female animals during the observation period. No significant abnormalities were found at necropsy in the animals at termination of the study.

LD50 > 2000 mg/kg

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Additional information

The acute toxicity of the test material was investigated following oral administration of a single dose to the rat, according to the OECD Guideline 401.

The test substance was administered to rats of both sexes by oral gavage, at a dose of 2000 mg/kg.
The following death rate was observed:
0% at 0 mg/kg (control group)
0% at 2000 mg/kg

No clinical signs of toxicity were observed during the observation period.

The acute oral LD50 of the test substance in rats of both sexes, observed over a period of 14 days, was estimated to be greater than 2000 mg/kg.

 

The acute toxicity of the test material was investigated following dermal administration of a single dose to the rat, according to the OECD Guideline 402. A single dose of 2000 mg/kg was administered to a group of 5 male and 5 female animals for 24 hours, under semiocclusive dressing. Animals were observed up to day 15. After 14 days, all animals were killed and subjected to necropsy examination.

No mortality occurred and no signs of toxicity were observed in male or female animals during the observation period. No significant abnormalities were found at necropsy in the animals at termination of the study.

LD50 > 2000 mg/kg

Justification for classification or non-classification

The CLP Regulation (EC 1272/2008), Annex I, Part 3, Table 3.1.1 gives the following criteria for acute oral and dermal toxicity: "Category 4: 300 < ATE ≤ 2000," where ATE is acute toxicity estimates in mg/kg bodyweight.

 

Based on the test material, LD50 was determined to be > 2000 mg/kg bw both for oral and dermal exposure therefore, the test substance is not classified for acute toxicity.