Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Quality of whole database:
K1, GLP compliant study conducted according to OECD test method.

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

INTRODUCTION

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the OECD Guidelines for the testing of Chemicals No 423 "Acute Oral Toxicity - Acute Toxic Class Method" (adopted 17 December 2001).

METHOD

A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bw. This was followed by a further group of three fasted females at the same dose level.

The test material was administered orally undiluted. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality: One animal was found dead the day after dosing.

Clinical observations: Signs of systemic toxicity noted during the study were hunched posture, ataxia, lethargy, pilo-erection, diuresis, decreased respiratory rate and laboured respiration. Surviving animals appeared normal two or three days after dosing.

Body weight: The surviving animals showed expected gains in body weight over the study period.

Necropsy: Abnormalities noted at necropsy of the animal that died during the study were abnormally red lungs, dark liver and dark kidneys. No abnormalities were noted at necropsy of animals that were killed at the end of the study.

CONCLUSION

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated as being greater than 2000 mg/kg bw.

Acute inhalation toxicity

REACH Annex VIII, Section 8.5, Column 2, states that information on acute toxicity will be provided for the oral route plus at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. The test material is a liquid with a vapour pressure of 5.2 x 10E-04 Pa at 25 °C, which makes generation of inhalable forms of the substance unlikely. As a result, it is considered that inhalation exposure will be low and the most likely route of exposure for workers and consumers is the dermal route. Testing for acute toxicity via the inhalation route is consequently not applicable.

Acute Dermal Toxicity

INTRODUCTION

The study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the OECD Guidelines for the Testing of Chemicals No 402 "Acute Dermal Toxicity" (adopted 24 February 1987) and Commission Directive 92/69/EEC Method B.3 Acute Toxicity (Dermal).

METHOD

Initially, two animals (one male and one female) were given a single, 24 hour, semi-occluded dermal application of the undiluted test material to intact skin at a dose level of 2000 mg/kg bw. Based on the results of the initial test, a further group of eight animals (four males and four females) were similarly treated. Clinical signs and bodyweight 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: There were no signs of dermal irritation.

Bodyweight: All animals showed expected gains in bodyweight over the study period.

Necropsy: No abnormalities were noted at necropsy.

CONCLUSION

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification for acute toxicity according to the Regulation (EC) No. 1272/2008..

Self classification:

Based on the available data, no additional classification for acute toxicity is proposed according to Regulation (EC) No. 1272/2008 (CLP) .