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Description of key information

GLP compliant acute oral toxicity study performed according to the OECD 420 test guideline.

GLP compliant acute oral toxicity studies performed according to non-OECD test method.

GLP compliant acute dermal toxicity study performed according to the OECD 402 test guideline.

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 adverse effect observed

Additional information

Acute Oral Toxicity in the Rat

Key Study

Introduction

The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat, using the OECD 420 test method.

Methods

Following a sighting test at a dose level of 2000 mg/kg, a further group of four fasted females was given a single oral dose of test item, unchanged, 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. No deaths.

Clinical Observations. There were no signs of systemic toxicity.

Body Weight. All animals showed expected gains in body weight.

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.

Supporting Studies

The test substance was dosed undiluted at 5.0 g/kg by oral gavage to 5 male and 5 female albino rats that had been fasted overnight. 1 male and 2 female rats died on each of Day 1 and Day2. The remaining 4 animals (3 males and 1 female) survived until the end of the observation period. The test substance was determined to have an acute oral LD50 of less than 5.0 g/kg.

In a supporting study the test substance was dosed undiluted at 2.0 g/kg by oral gavage to 5 male and 5 female albino rats that had been fasted overnight. There were no premature mortalities recoded during the 14 -day observation period. The test substance was determined to have an acute oral LD50 of greater than 2.0 g/kg.

Acute inhalation toxicity

According to REACH Annex VIII, Section 8.5, Column 2, information on acute toxicity shall be provided for at least one other route in addition to the oral route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. The substance is a liquid with a vapour pressure of 0.013 Pa at 25°C and, based on evaluation of the life cycle of the substance, it is expected that exposure inhalation exposure will be low. The most likely route of exposure for workers and consumers is considered to be the dermal route and testing for acute toxicity via the inhalation route is not required.

Acute Dermal Toxicity in the rat.

Introduction. The study was performed to assess the acute dermal toxicity of the test item in the Wistar strain rat. The method was designed to be compatible with the following:

OECD Guidelines for the Testing of Chemicals No. 402 “Acute Dermal Toxicity” (adopted 24 February 1987)

Method B3 Acute Toxicity (Dermal) of CommissionRegulation (EC) No. 440/2008

Method. Initially, two animals (one male and one female) were 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 bodyweight. Based on the results of the initial test, a further group of eight animals (four males and four females) was similarly treated. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality. There were no deaths.

Clinical Observations. There were no signs of systemic toxicity.

Dermal Irritation. Signs of dermal irritation noted at test sites of females included very slight erythema, very slight edema, hemorrhage of the dermal capilliaries, crust formation, glossy skin and small superficial scabs. There were no signs of dermal irritation in the males.

Bodyweight. All animals showed expected gains in body weight.

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 bodyweight.

Justification for selection of acute toxicity – oral endpoint

Klimisch grade 1, GLP compliant study performed according to OECD 420 test method.

Justification for selection of acute toxicity – dermal endpoint

Klimisch grade 1, GLP compliant study performed according to OECD 402 test method.

Justification for classification or non-classification

The oral LD50 is greater than 2000 mg/kg, therefore no classification is warranted under CLP.

The dermal LD50 is greater than 2000 mg/kg, therefore no classification is warranted under CLP.