A 2:1:1 mixture of: trisodium N(1')-N(2):N(1''')-N(2'')-η-6-[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]-6''-(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'-azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate

Endpoint summary

Description of key information

LD50 (oral, rat) > 5000 mg/kg bw

LD50 (dermal, rat) > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Acute oral toxicity

Acute oral toxicity of the substance was evaluated in an experimental study performed according to the OECD Guideline 401 (1987) and EU method B.1 (1984).

No mortality was observed at 2000 mg/kg bw, and 20 % mortality was observed at the higher dose of 5000 mg/kg bw. Toxic symptoms of sedation, dyspnoea, hunched posture and ruffled fur were observed in one male and one female animal administered 2000 mg/kg bw until day 4 and 5, respectively at 2000 mg/kg bw; toxic symptoms of sedation, dyspnoea, ataxia, hunched posture, diarrhoea and ruffled fur were observed in 1 - 2 male and 1 - 2 female animals until day 3 at 5000 mg/kg bw. Body weights of all animals remained constant. No gross pathological changes were observed among animals administered at 2000 mg/kg bw or the surviving animals administered at 5000 mg/kg bw; the two animals of the higher dose who died during the study period were found to have several dark red foci, partly black, of the lungs and black liver, stomach, intestines, kidneys, adrenal glands and spleen.

The LOGIT-Model could not be applied to these data. Based on these findings, the acute oral toxicity of the test item in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 5000 mg/kg bw Therefore, it can be extrapolated that the LD50 is greater than 5000 mg/kg bw.

Acute inhalation toxicity

Study considered as scientifically not necessary: the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Acute dermal toxicity

Acute dermal toxicity of the test item was evaluated in an experimental study performed according to the OECD Guideline 402 (1987) and the EU Method B.3 (1984).

No mortality was observed. Local discolouration was observed after removal of the bandage (24 hours after application) until end of the observation period. Body weights of the animals remained constant. No pathological changes were observed at necropsy.

The LOGIT-Model could not be applied to these data. The acute dermal toxicity of the test item in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg bw. Therefore, it can be extrapolated that the LD50 is greater than 2000 mg/kg bw.

Justification for classification or non-classification

According to the CLP criteria for acute toxicity (EC) No. 1272/2008, substances can be allocated to one of four hazard categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in the table. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE). 

Acute toxicity hazard categories and acute toxicity estimates (ATE) are defined by the respective categories:

		Danger	Danger	Danger	Warning
	Unit	Category 1	Category 2	Category 3	Category 4	No Classification
ORAL	mg/kg bw	LD50 ≤ 5	5 < LD50 ≤ 50	50< LD50 ≤ 300	300< LD50 ≤ 2000	LD50> 2000
DERMAL	mg/kg bw	LD50 ≤ 50	50< LD50 ≤ 200	200< LD50 ≤ 1000	1000< LD50 ≤ 2000	LD50> 2000

According to the studies available, the test item cannot be classified as having an acute oral or dermal toxicity as the median lethal dose does not fulfill the abovementioned CLP criteria (LD₅₀> 2000 mg/kg bw in both cases).