Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: The LD50 for male and female rats was greater than 2000 mg/kg bw.
Acute dermal toxicity: A LD50 value of > 2000 mg/kg bw was determined for the test substance.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
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:
discriminating dose
2 000 mg/kg bw

Additional information

Acute toxicity: oral

Key study:

Acute toxicological investigations with male and female Wistar rats were conducted after oral administration (gavage) of the test substance in accordance with OECD guideline 401. The LD50 for male and female rats was determied to be greater than 2000 mg/kg bw and was not exactly determined. The following signs of intoxication were observed: rough coat, increased salivation and apathy. The body weight development of male and female rats was not affected. No animal died during the 14-day observation period. None of the animals sacrificed at the end of study showed any unusual gross pathological features.

Supporting study:

Acute toxicological investigations with male Wistar rats were conducted after oral administration (gavage) of the test substance formulated in luterol. The LD50 for male was determied to be greater than 5 g/kg bw and was not exactly determined. The following signs of intoxication were observed: increased diuresis. No animal died during the 14-day observation period.

 

Acute toxicity: inhalation

According to REACH Regulation (EC) No 1907/2006, Annex VIII, 8.5 data for a maximum of two routes of exposure need to be provided. Testing for acute toxicity via the inhalation route was not applicable as data on acute oral and acute dermal toxicity were available. Furthermore, as the vapour pressure is very low exposure to Incozol EH is therefore unlikely, so the acute toxicity via inhalation was waived also for animal welfare reasons.

 

Acute toxicity: dermal

The test substance was examined for its acute dermal toxicity similar to EU method B.3. Ten Wistar rats were equally divided to sex. A dose of 2000 mg/kg bw was applied. The hair was clipped from the back of each animal, the test substance was applied for 24 hours and the application site was covered with patches and aluminium foil. After an observation time of 14 days no mortality was observed. The growth of male rats were not influenced. Female animals showed a temporarily decrease or stagnation of their body weight. Systemic symptoms of poisoning and local changes on the skin were not observed. All animals that were sacrified at the end of the study did not show any conspicious symptoms.Thus, the deduced LD50 values is > 2000 mg/kg bw.

 


Justification for selection of acute toxicity – oral endpoint
GLP and guideline study

Justification for selection of acute toxicity – dermal endpoint
GLP and guideline study

Justification for classification or non-classification

Based on the available data the test item is not classified for acute oral, dermal and inhalation toxicity according to Regulation (EC) No 1272/2008 and Directive 67/548/EEC.