Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity

LD50 > 2000 mg/kg bw/day (based on assessment)

Acute dermal toxicity

LD50 > 2000 mg/kg bw (based on assessment)

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

Only short abstracts on the acute oral and dermal toxicity are available for the test item and no information on the composition of the batches tested and on the procedures used is reported.

The acute oral toxicity studies available show LD50 values of 4500 and > 5000 mg/kg bw/day, respectively. In addition to this, data obtained form the repeated dose toxicity study via oral route was considered. The NOAEL found under test conditions was > 1000 mg/kg bw/day.

Two in vivo dermal toxicity studies were carried out on the test substance. The LD50 calculated in the two studies are respectively 1000 and greater than 5000 mg/kg bw/day. One of the two studies (LD50: 1000 mg/kg bw/day) was however disregarded due to inconsistencies with the results of the corrispondent study via oral route (details in the assessment on dermal toxicity).

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 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 2000 mg/kg body weight, upon assessment, therefore test substance is out of the 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 greater than 2000 mg/kg body weight, upon assessment, therefore the test substance is out of the classification limit for acute dermal toxicity (dermal acute toxicity category 4: 1000 < ATE ≤ 2000 mg/kg bw).

Inhalation exposure is unlikely, thus no acute toxicity value is available and no further investigation is required.

In conclusion, test substance does non meet the criteria to be classified for either oral and dermal acute toxicity, according to the CLP Regulation.