Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: LD50 5000 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
5 000 mg/kg bw
Quality of whole database:
Test available on the registered substance.
Data available on similar substances confirm the result.

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
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

Data are available on the registered substance, the Similar substance 01 and 02.Based on the read-across principle, the results can be considered for the toxicity assessment of the registered substance. Justification for read-across is detailed in the report attached to the IUCLID section 13.

Acute Oral

A 25% W/V suspension of the registered substance in tap water was administered as a single dose by gavage to rats, no in GLP. After administration of the compound, the animals were observed for 14 days. The acute oral median lethal dose (LD50) in rats was stated greater than 5 g/kg body weight.

10 young adult rats were treated with 2000 mg/kg of the Similar substance 01 solved in water was administrated in one single oral dose by gastric intubation. After 14-day post-treatment observation period, the LD50 in rats of both sexes is greater than 2000 mg/kg body weight.

Groups of 5 male and 5 female rats were treated with various single doses of the Similar substance 01. The acute oral LD50 in rats was calculated to be 8700 mg/kg.

A limit dose of 2000 mg/kg bw of a Similar substance 02 was administered to 6 rats (3 males and 3 females). The found LD 50 was >2500 mg/kg.

Acute dermal

A group of ten animals (five males and five females) was given a single, 24 hours, semi-occluded dermal application of the Similar substance 01 to intact skin at a dose level of 2000 mg/kg bodyweight. The observation on mortality showed that there were no deaths. Clinical observations showed no signs of systemic toxicity.

The found LD 50 was 2000 mg/kg.

2 males and 2 females New Zealand White rabbits were dosed at 2.0 g/kg of body weight of the Similar substance. The substance was prepared at 50% w/v in distilled water.

The rabbits were observed daily for 14 days for signs of toxicity, pharmacological effects and mortality.

all animals survived this test at 2.0 g/kg of body weight and the test material is considered not toxic at this dose level.

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 substance was established to be 5000 mg/kg body weight.

The similar substance 01, with LD50 2000 mg/Kg/bw 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 registered substance 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 registered substance is not classified for dermal toxicity because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008.