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Administrative data

Description of key information

Acute oral toxicity: LD50 > 2000 mg/kg body weight

Acute inhalation toxicity: waiving

Acute dermal toxicity: LD50 > 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
Quality of whole database:
This is the only test available, performed on a similar substance 01.
However, it follows the OECD 423 Guideline, the EU B.1.tris and it was performed in GLP. Hence, It can be consider a key study.

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
Quality of whole database:
This is the only test available, performed on a similar substance 01.
However, it follows the OECD 402 Guideline, the EU B.3 and it was performed in GLP. Hence, It can be consider a key study.

Additional information

Acute Oral

The acute oral toxicity test was performed on a similar substance (read-across from supporting substance -structural analogue or surrogate, following the OECD 423 Guideline and EU B.1 tris (Acute Toxicity-Oral, Acute), in GLP.

No mortality occurred. No clinical signs of systemic toxicity were noted in any of the animals. Brown and/or black staining of the neck and/or tail by the test substance was noted among the animals during the study period. The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.

The oral LD50 value of the similar substance 01 in Wistar rats was established to exceed 2000 mg/kg body weight.

Acute dermal

The dermal oral toxicity test was performed on a similar substance (read-across from supporting substance -structural analogue or surrogate,following the OECD 402 Guideline and EU B.3, in GLP.

No mortality occurred. Brown staining of various body parts (considered to be related to staining properties of the test

substance) and/or chromodacryorrhoea was noted among all animals between days 1 and 8. The body weight gain during the observation period was within the range expected for rats used in this type of study.

No abnormalities were found at macroscopic post mortem examination of the animals.

The dermal LD50 value in Wistar rats was established to exceed 2000 mg/kg body weight (actual dose 2176 mg/kg body weight).

Justification for classification or non-classification

Oral acute toxicity

According to the CLP Regulation 1272/2008/EC, 3.1.2.1 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 shown in Table 3.1.1:

Oral (mg/kg body weight)

Category 1: LD50 ≤ 5

Category 2: 5 <LD50 ≤ 50

Category 3: 50 < LD50 ≤ 300

Category 4: 300 < LD50 ≤ 2 000

The oral LD50 value of the similar substance in Wistar rats was established to exceed 2000 mg/kg body weight.

The similar substance 01 is not classified for oral toxicity because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008; hence, according to the read-across from supporting substance -structural analogue evaluation, also the substance 01 is not classified for this endpoint.

Acute dermal toxicity

According to the CLP Regulation 1272/2008/EC, 3.1.2.1 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 shown in Table 3.1.1:

Dermal (mg/kg body weight)

Category 1: LD50 ≤ 50

Category 2: 5 <LD50 ≤ 200

Category 3: 50 < LD50 ≤ 1000

Category 4: 300 < LD50 ≤ 2 000

The oral LD50 value of the Similar substance 01 in Wistar rats was > 2000 mg/kg/body weight.

Based on the read-across principle(read-across from supporting substance -structural analogue or surrogate), the result can be considered for the acute dermal toxicity assessment of the substance. Justification for read-across is detailed in the report attached to the IUCLID section 13.

The substance is not classified for dermal toxicity because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008.