Registration Dossier

Administrative data

Description of key information

Acute mammalian toxicity in rats, exposed by the oral (gavage), inhalation and dermal routes.
LD50 (oral): > 5000 mg/kg bw
LC50 (inhalation): > 1.9 mg/L air
LD50 (dermal): > 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Based on the available study data, this dataset is considered to be sufficiently reliable for classification purposes.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Based on the available study data, this dataset is considered to be sufficiently reliable for classification purposes.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Based on the available study data, this dataset is considered to be sufficiently reliable for classification purposes.

Additional information

During exposure to the substance and read-across substances via the oral, dermal and inhalation routes, only minor incidences of mortality were observed and never at a rate considered to be significant when dosing levels were at or below the volumes specified below. Where significant mortality has been observed, this was observed at dose levels significantly higher than those specified below and thus beyond the limits of classification. The limit values expressed below are, therefore, considered appropriate.

LD50 (oral): > 5000 mg/kg bw

LC50 (inhalation): > 1.9 mg/L air

LD50 (dermal): > 5000 mg/kg bw


Justification for selection of acute toxicity – oral endpoint
The acute oral endpoint has been addressed on a weight of evidence basis to several read-across substances using the category approach.
All read-across studies were performed according to standardised guidelines and under GLP conditions, with the exception of the studies designated “acute oral-6” and “acute oral-7” which were not performed to GLP, and with the exception of the study designated “acute oral-10” which was not performed to a standardised guideline or under GLP conditions.
Accordingly these studies have been assigned reliability scores of 2 (reliable with restrictions) in line with the principles of Klimisch et al. (1997).
A study using the substance to be registered has also been provided. Since the study was presented as a short abstract, with insufficient reporting of the methodology and experimental conditions, it has been assigned a reliability score of 4 in line with the principles of Klimisch et al. (1997) and has been used as part of the weight of evidence approach to support non classification of this substance.

Justification for selection of acute toxicity – inhalation endpoint
The acute inhalation endpoint has been addressed in the key study using read-across to petroleum derived calcium salt overbased. The study was performed according to OECD guidelines and under GLP conditions. This study was assigned a reliability score of 2 (reliable with restrictions) in line with the principles of Klimisch et al. (1997). While there is an inhalation study on the test substance itself, the concentration administered to the rats is not defined. Therefore, the read across study was deemed more reliable. No mortalities were observed in either study.
A supporting study using the substance to be registered has also been provided. Since the study was presented as a short abstract, with insufficient reporting of the methodology and experimental conditions, it has been assigned a reliability score of 4 in line with the principles of Klimisch et al. (1997) and has been used to support the findings of the key study.

Justification for selection of acute toxicity – dermal endpoint
The acute dermal endpoint has been addressed on a weight of evidence basis using several read-across substances. These studies were performed according to OECD guidelines and under GLP conditions and have been assigned reliability scores of 2 (reliable with restrictions) in line with the principles of Klimisch et al. (1997).
A supporting study using the substance to be registered has also been provided. Since the study was presented as a short abstract, with insufficient reporting of the methodology and experimental conditions, it has been assigned a reliability score of 4 in line with the principles of Klimisch et al. (1997) and has been used as part of the weight of evidence approach to support non classification of this substance.

Justification for classification or non-classification

Based on the available data, the substance is considered to be not classified as acutely toxic, via the oral, inhalation and dermal routes in accordance with Regulation (EC) No. 1272/2008.