reaction product of: C.I. Leuco Sulfur Black 1 with (3-chloro-2-hydroxypropyl)trimethylammonium chloride

Endpoint summary

Description of key information

LD50 (oral, rat)> 2000 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:

2 000 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 that was performed according to the OECD Guideline 401 (1987) and EU method B.1 (1992). The test item was administered to 10 rats (5 male, 5 female) by oral gavage, at 2000 mg/kg bw. 0 % death rate was observed. The LOGIT-Model could not be applied to these data. No clinical signs or gross pathology findings were observed. 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 2000 mg/kg bw. Therefore, it can be extrapolated that the LD50 is greater than 2000 mg/kg bw.

Acute Dermal Toxicity

Acute dermal toxicity of the test item was evaluated in an experimental study that was performed according to the OECD Guideline 402 (1987) and EU method B.3 (1992). 2000 mg/kg bw of the test item was applied dorsally to 10 rats of both sexes for a duration of 24 hours.

A death rate of 0 % at 2000 mg/kg bw was observed. Local discolouration was observed between 24 hours and end of observation period. 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 (dermal, rat) is greater than 2000 mg/kg bw.

Acute toxicity other routes: Subcutaneous

Acute dermal toxicity by subcutaneous injection of the test item was evaluated in an experimental study that was performed in a similar way to the OECD Guideline 402 (1987) and EU method B.2 (1992). The test item was administered subcutaneously at doses 20, 100 and 2000 mg/kg bw by subcutaneous injection (5 male and 5 female rats per dose). The following mortality rates were observed:

20 mg/kg bw: 0 %

100 mg/kg bw: 30 % (3 males)

2000 mg/kg bw: 100 % (5 males, 5 females)

No clinical signs were observed among test subjects administered 20 mg/kg bw. Test subjects administered either 100 or 2000 mg/kg bw test item demonstrated sedation, convulsions, ventral recumbancy and dyspnea. Test subjects administered 100 mg/kg bw also demonstrated uncoordinated movements and ruffled fur. The body weight gain was withln the normal range in animals of this strain and age.

No macroscopical findings were observed in any of the animals. Based on these observations, the mean lethal dose (LDGIT-model) for the acute subcutaneous toxicity in rats of both sexes observed for a period of 14 days is 187.18 mg/kg (for males 119.01 mg/kg; for females 325.67 mg/kg).

Justification for classification or non-classification

According to the CLP criteria for acute toxicity (EC 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).