Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Oral:
Reliable data from guideline studies on acute toxicity after oral application are available for three members of the category of derivatives of 4,4’-bis(1,3,5-triazinyl-2-yl)amino)stilbene-2,2’-disulfonic acid, each with one anilino and one alkyl amino moiety: EC 432-690-8, 476-900-6 and EC 416-640-2. These data reveal avery low acute oral toxicity of this category: LD50 values for all investigated test items in rats are above 2000 mg/kg bw, the upper limit for classification.
Therefore, it is concluded that the substance defined in section1 is not acute toxic via the oral route.

Inhalation:

The test material is produced and handled in industry exclusively in aqueous solutions. There are no spraying operations. Thus neither exposure nor risks are expected via the inhalation route.

Dermal:
Reliable data from guideline studies on acute toxicity after dermal application are available for two members of the category of derivatives of 4,4’-bis(1,3,5-triazinyl-2-yl)amino)stilbene-2,2’-disulfonic acid, each with one anilino and one alkyl amino moiety: EC 476-900-6 and EC 416-640-2. These data reveal avery low acute dermal toxicity of this category: LD50 values for the investigated test items in rats are above 2000 mg/kg bw, the upper limit for classification.
Therefore, it is concluded that the substance defined in section1 is not acute toxic via the dermal route.

 

EC 432-690-8:
The acute oral toxicity of the substance when administered by a single oral gavage to rats was assessed in an OECD 423 study. The substance did not cause any relevant adverse effects after single oral exposure to 2000 mg/kg bw in rats.

EC 476-900-6:
The acute oral toxicity of the substance when administered by a single oral gavage to rats was assessed in an OECD 423 study. The test substance was applied once by oral gavage at a dosage of 2000 mg/kg bw to two groups of three female rats each followed by a 14 day observation period. All animals survived until the end of the study. No clinical signs were observed. Bodyweights of the animals were within the commonly recorded range for this strain. The LD50 oral, rat (female) was greater than 2000 mg/kg bw.

The acute dermal toxicity of the test substance when administered by a single dermal application to rats was assessed in an OECD 402 study. Five male and five female rats were treated with the test substance registered at a single dermal dose of 2000 mg/kg bw. Application period was 24 hours followed by a 14 day observation period. No death occurred during the study. No clinical signs were observed. Bodyweights of the animals were within the commonly recorded range for this strain. No macroscopic findings were recorded. The LD50 dermal, rat was greater than 2000 mg/kg.

EC 416-640-2:
The acute oral toxicity of the substance when administered by a single oral gavage to rats was assessed in an OECD 401 study. The test substance was applied once by oral gavage at a dosage of 2000 mg/kg bw. No clinical signs were observed. The LD50 oral, rat was greater than 2000 mg/kg.

The acute dermal toxicity of the test substance when administered by a single dermal application to rats was assessed in an OECD 402 study. Five male and five female rats were treated with the test substance registered at a single dermal dose of 2000 mg/kg bw. Application period was 24 hours followed by a 14 day observation period. No clinical signs were observed. Bodyweights of the animals were within the commonly recorded range for this strain. No macroscopic findings were recorded. The LD50 dermal, rat was greater than 2000 mg/kg.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the category members are not considered to be classified for acute oral, dermal or inhalatory toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the category members are not considered to be classified for acute oral, dermal or inhalatory toxicity under Regulation (EC) No. 1272/2008