Registration Dossier

Administrative data

Description of key information

Oral, LD50 = 550 mg/kg (C.I. 123.9-3930 mg/kg bw), female rat, OECD 425, Kiss (2012)
Dermal, LD50 > 2000 mg/kg, male/female rats, OECD 402, Zelenak (2012)

Inhalation, LC50 > 1.28 mg/L, male /female Wistar strain rats, OECD 403, Nagy (2013)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
550 mg/kg bw
Quality of whole database:
The key study is a GLP compliant guideline study with a Klimisch score of 1.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
1 280 mg/m³
Quality of whole database:
The key study is a GLP compliant guideline study with a Klimisch score of 1.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The key study is a GLP compliant guideline study with a Klimisch score of 1.

Additional information

Unreliable screening studies which were not conducted for the purposes of REACH were discarded. Only studies conducted according to guidelines and under OECD GLP were selected as key studies for use in classification.

An acute inhalation toxicity study was conducted in accordance with OECD TG 403 (2009) and under OECD GLP. The main study group (Group 1), consisting of 10 (5 male and 5 female) CRL: (WI) Wistar strain rats was exposed to a target aerosol concentration of 1 mg/L. The animals were exposed for 4 hours using a nose-only exposure system, followed by a 14 day observation period. The day of exposure was designated Day 0. Aerosol concentrations were measured by the analytical GC method. The particle size distribution of the test aerosol was determined regularly during the exposure period. Clinical observations and bodyweights were recorded throughout the study and at the end of the scheduled period the animals were euthanised and subjected to a gross examination post mortem. Under the experimental conditions of the main study, 1/5 male and 1/5 female died in rats exposed to a mean achieved atmosphere of 1.28 mg/L for 4 hours exposure. The acute inhalation median lethal concentration of the test material in CRL: (WI) Wistar strain rats is therefore considered to be greater than 1.28 mg/L.

This inhalation study was performed for a chemical registration scheme outside of the European Economic Area. Permission to refer to the full study report is not available to the registrant, and this information is thus not provided as a robust study summary according to REACH Art. 10(a)(vi) or (vii). However, the results of the study are provided here to support the correct classification and labelling of the substance.

The data provided for this endpoint is considered to be relevant, adequate, reliable and complete for the purposes of classification and risk assessment.

Justification for classification or non-classification

An Oral LD50 of 550 mg/kg bw of the test substance means that it is a Category 4 Classification for Acute Oral Toxicity under EC no. 1272/2008 CLP criteria.

An Dermal LD50 of >2000 mg/kg bw of the test substance means that it is not classified for Acute Dermal Toxicity under EC no. 1272/2008 CLP criteria.

An Inhalation LC50 of > 1.28 mg/Lof test substance means that it is a Category 4 classification for Acute Inhalation Toxicity under EC no. 1272/2008 CLP criteria.