Black HM 2482

Endpoint summary

Description of key information

LD50 (oral) > 5000 mg/kg bw (rat, male and female)
LD50 (dermal) > 2000 mg/kg bw (rat, male and female)

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

The test item was evaluated for acute oral toxicity in Wistar rats as per OECD Guideline No. 401.
The test item was administered to rats of both sexes by oral gavage at a dose of 5000 mg/kg. The following death rate was observed: 0% at 5000 mg/kg. Dyspnea was observed in treated animals and all rats had recovered within 3 hours after treatment. No macroscopic organ changes were observed.

 

Acute inhalation toxicity
The substance has a low volatility (V.P. c.a. 0 kPa) and does not present any inhalable/respirable particles. In humans, particles with aerodynamic diameters below 100 μm have the potential to be inhaled. Particles with aerodynamic diameters below 50 µm may reach the thoracic region and those below 15 µm the alveolar region of the respiratory tract. Τhe substance does not contain any particles with a diameter less than 15 μm. Furthermore, no systemic toxicity occurred during the acute oral toxicity test; the absence of systemic toxicity and the absence of other data that could indicate the potential for absorption following ingestion, support the idea that it is unlikely that the substance will be absorbed in case it is inhaled. The properties of the substance and the absence of systemic toxicity in the oral toxicity test indicate that human exposure is not possible via inhalation, therefore testing via this route for acute toxicity should not be conducted.

 

Acute dermal toxicity

The test item was evaluated for acute dermal toxicity in Wistar rats as per OECD Guideline No. 402.
The test item was administered to rats of both sexes at a dose of 2000 mg/kg. The following death rate was was observed: 0% at 2000 mg/kg. No local or systemic symptoms were observed in any treated animal. No macroscopic organ changes were observed. The LD50 of the test item was estimated to be greater than 2000 mg/kg.

 

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

The oral LD50 value was established to be greater than 5000 mg/kg, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity category 4: 300 < ATE ≤ 2000 mg/kg bw).

The dermal LD50 value was established to be higher than 2000 mg/kg, which exceeded the highest CLP limit for classification (dermal acute toxicity category 4: 1000 < ATE ≤ 2000 mg/kg bw).

In conclusion, the test substance is non classified for oral/dermal acute toxicity, according to the CLP Regulation (EC 1272/2008).