Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: LD50(rats, hamsters) > 20 mL/kg bw, ca. 18.8 g/kg bw ; LD50(mice) = 3.9 mL/kg bw, ca. 2.8 g/kg bw (No guideline; rel.2, K)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Data on a single study reported in different reports or publications
Guideline:
other:
Principles of method if other than guideline:
Method not detailed. Five male and five female Fischer 344 rats, five female CS7BL/6 mice and five male Golden syrian hamsters were treated with undiluted test substance at a maximum dose level of 20 mL/kg body weight and observed for 14 days.
GLP compliance:
no
Remarks:
Pre-GLP but the experiments were conducted according to the "Guide for the Care and Use of Laboratory Animals," Institute of Laboratory Animal Resources, National Research Council.
Test type:
standard acute method
Limit test:
yes
Species:
other: rats, mice and hamsters
Strain:
other: rats: Fischer 344; mice: C57BL/6; hamsters: Golden Syrian
Sex:
male/female
Details on test animals or test system and environmental conditions:
Not specified
Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Doses:
20 mL/kg bw
No. of animals per sex per dose:
rats: 5/sex/dose; mice: 5 females/dose; hamsters: 5 males/dose
Control animals:
no
Details on study design:
Five male and five female Fischer 344 rats, five female CS7BL/6 mice, five male Golden syrian hamsters; maximum dose of 20 mL/kg body weight; observation for 14 days.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw
Based on:
test mat.
Remarks on result:
other: Rats
Remarks:
ca. LD50 > 18.8 g/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw
Based on:
test mat.
Remarks on result:
other: Hamsters
Remarks:
ca. LD50 > 18.8 g/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 3.9 mL/kg bw
Based on:
test mat.
95% CL:
>= 2.2 - <= 6.9
Remarks on result:
other: Mice
Remarks:
LD50 calculated using the moving average method of Weil. ca. LD50 = 2.8 g/kg bw
Mortality:
Partial mortality in rats and hamsters.
In mice, all deaths occurred within 48 hours of dosing.
Clinical signs:
Convulsions were observed immediately preceding death.
Gross pathology:
Necropsy of dead revealed congested lungs and GI tract.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Under the test conditions, the substance is not classified according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and classified in Category 5 according to the GHS as the worst-case estimated oral LD50 is between 2000 than 5000 mg/kg bw.
Executive summary:

In an acute oral toxicity study performed in 1979, five male and five female Fischer 344 rats, five female C57BL/6 mice and five male Golden syrian hamsters were treated with undiluted test material at a dose level of 20 mL/kg bw. Animals were then observed for 14 days.

Deaths observed in rats and hamsters but not enough to determine a LD50 value.

In mice, deaths occurred within 48 hours of dosing with convulsions were observed immediately preceding death.

Necropsy of dead revealed congested lungs and GI tract.

In rats and hamsters, oral LD50 > 20 mL/kg bw, which is equivalent to 18.8 g/kg bw.

In female mice, oral LD50 = 3.9 mL/kg bw, which is equivalent to 2.8 g/kg bw.

Under the test conditions, the substance is not classified according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and classified in Category 5 according to the GHS as the worst-case estimated oral LD50 is between 2000 and 5000 mg/kg bw.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 800 mg/kg bw
Quality of whole database:
The Key study was initially published in 1979 and used in several technical reports and reviews. Compiling the data more or less detailed in different sources, this study was considered sufficiently robust to cover this endpoint.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A key study was identified (1979, rel.2) In an acute oral toxicity study performed in 1979 and reused in several official report or review, five male and five female Fischer 344 rats, five female C57BL/6 mice and five male Golden syrian hamsters were treated with undiluted test material at a dose level of 20 mL/kg bw. Animals were then observed for 14 days.

Several deaths observed in rats, hamsters and mice in which all deaths occurred within 48 hours of dosing with convulsions immediately preceding death.

Necropsy of dead revealed congested lungs and GI tract.

In rats and hamsters, oral LD50 > 20 mL/kg bw, which is equivalent to 18.8 g/kg bw.

In femal mice, oral LD50 = 3.9 mL/kg bw, which is equivalent to 2.8 g/kg bw.

Justification for classification or non-classification

Harmonized classification:

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

Self classification:

Acute toxicity via Oral route:

Under the test conditions, the substance is not classified according to the criteria of Annex I to the Regulation (EC) No. 1272/2008 (CLP) but classified in Category 5 according to the GHS as the estimated oral LD50 is between 2000 and 5000 mg/kg bw.

Moreover, based on effects observed in the acute oral toxicity study, and its hydrocarbon structure and low viscosity, the test substance should be classified for aspiration hazard (H304) according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP).

Acute toxicity via Dermal route:

No data was available.

Acute toxicity (Inhalation):

No data was available.

Specific target organ toxicity: single exposure (Oral):

The classification criteria according to the Annex I of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw≥C > 300 mg/kg bw). No classification is required.

The criteria for Transient Organ effects (STOT-SE Category 3) according to Annex I of the Regulation (EC) No. 1272/2008 are not met since narcotic effects were not observed in the acute oral toxicity study.

Specific target organ toxicity: single exposure (Dermal):

No data was available.

Specific target organ toxicity: single exposure (Inhalation):

No data was available.