Registration Dossier

Administrative data

Description of key information

LD50 > 2000 mg/kg b.w

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

ACUTE ORAL TOXICITY

The following data was obtained for Similar Substance 01. It is expected that Target substance will present similar acute oral toxicity. Justification for Read Across is given in Section 13 of IUCLID.

The study was conducted according to the method described into the Directive EC n. 67/548 Annex IV B. B.1 .ter. The substance was administrated by gavage to six rats (3 males and 3 females) at a concentration of 2000 mg/kg bw.

No clinical symptoms were recorded and no deaths occurred. During autopsy no macroscopic changes were seen.

Acute toxicity experimental data obtained using Target Substance is available. Unfortunately, the reliability of the data cannot be judged because of the lacking of details about test material and testing procedures and conditions.

REFERENCE: details in attachment.

The substance was considered as nontoxic with single oral and dermal administration; its intraperitoneal toxicity, however, is slightly higher. Inhalation of an atmosphere saturated with the possibly volatile components of this product at 20 °C is tolerated without symptoms for 8 hours.

Oral and intraperitoneal toxicity

-Observation time: 7 days

-Application form: 3 to 30 % suspension in 0.5 % aqueous carboxymethyl cellulose solution

-Results: approximate - mean lethal dose = LD50 calculated according to LITCHFIELD-WILCOXON

LD50 (rat, oral) 9550 (9026-10104) mg/kg bw

LD50 (mouse, intraperitoneal) about 550 mg

-Symptoms:

Rats oral: Dyspnoea, sometimes slight apathy, diarrheal feces dyed black, tumbling.

Mice intraperitoneal: dyspnea, slight apathy, jumping spasms, spastic gait; skin brownish colored.

-Post mortem examination:

Rats oral: acute cardiac dilatation, congestive hyperemia, stomach dilated, fluid contents, ecchymosed in the glandular stomach, diarrheal intestinal contents, organs stained.

Mice intraperitoneal: intra-abdominal substance precipitation.

 

Dermal toxicity

-Observation time: 14 days

-Application form: 50 % aqueous preparation

-Results: approximate - mean lethal dose = LD50 calculated according to LITCHFIELD-WILCOXON

LD50 (rat, dermal) > 2500 mg/kg bw.

-Symptoms: no clinical signs observed

-Post mortem examination: no findings

 

Inhalation Toxicity

Inhalation of a saturated with steam at 20° C resp. dust-enriched atmosphere. To saturation or Enrichment was through an approx. 5 cm high layer of the product passed air.

-Duration of exposure: 8 h

-Test animal: rat

-Mortality (died / exposed animals): 0/12

-Symptoms: no clinical signs observed

-Post mortem examination: no findings

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008) acute toxicity means those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours.

The substance is not capable to produce adverse effects after acute administration by oral route, therefore no classification is warranted.