Registration Dossier

Administrative data

Description of key information

Oral: LD50, rat > 2000 mg/kg
Dermal: LD50, rat > 2000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Modern GLP study following OECD test guidelines, Klimisch grade 1.

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
Quality of whole database:
Modern GLP study following OECD test guidelines, Klimisch grade 1.

Additional information

ACUTE ORAL TOXICITY STUDY

Introduction

The study was performed to OECD Guideline No. 420 and EU Method B.1 bis to assess the acute oral toxicity of the test item in the Wistar strain rat.

Methods

Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test item, as a solution in arachis oil BP at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

Results

Mortality: There were no deaths.

Clinical Observations: Hunched posture and piloerections were noted in two animals during the day of dosing with hunched posture persisting in one animal one day after dosing. There were no signs of systemic toxicity noted in the additional treated animals.

Body Weight:All animals showed expected gains in body weight over the observation period

Necropsy:No abnormalities were noted at necropsy.

Conclusion

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was considered to be greater than 2000 mg/kg body weight

ACUTE DERMAL TOXICITY STUDY

Introduction

The study was performed to assess the acute dermal toxicity of the test item in the Wistar strain rat.

Methods

A group often animals (five males and five females) was given a single, 24 hour, semi-occluded dermal application of the undiluted test item to intact skin at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

Results

Mortality. There were no deaths.

Clinical Observations. There were no signs of systemic toxicity.

Dermal Irritation. Signs of dermal irritation noted were well-defined erythema, very slight edema, loss of skin elasticity and flexibility, light brown discolouration of the epidermis, crust formation and reduced growth of fur. All dermal reactions were considered to be completely reversible.

Body Weight. Animals showed expected gains in body weight except for one female which showed expected gains during the first week but body weight loss during the second week.

Necropsy. No abnormalities were noted at necropsy.

Conclusion

The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.

Justification for classification or non-classification

No adverse effects or deaths noted at 2000 mg/kg. No classification required.