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Description of key information

A reliable acute toxicity study via the oral route is available, concluding that the LD50 is > 2,000 mg/kg bw (no mortality observed).


In accordance with Annex VIII of REACH, Column 2, it is not required to investigate the toxicity of the substance following an acute exposure via the inhalation or dermal route.

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
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
The animals were housed in groups of up to four in suspended solid floor polypropylene cages furnished with woodflakes.

The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70% respectively.

The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

With the exception of an overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing, free access to tap drinking water and food.
Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
1 animal was dosed at 300 mg/kg.

1 animal was dosed at 2000 mg/kg followed by an additional 4 animals at 2000 mg/kg.
Doses:
300, 2000 mg/kg
No. of animals per sex per dose:
5 at 2000 mg/kg
Control animals:
no
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality.
Clinical signs:
No signs of systemic toxicity were noted during the observation period.
Body weight:
The animal showed expected gains in body weight over the observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 2000 mg/kg rat highest dose tested . No mortality observed.
Executive summary:

The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.
Following a sighting test at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test item, as a solution in arachis oil BP, 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.
There were no deaths nor signs of systemic toxicity. All animals showed expected gains in body weight. No abnormalities were noted at necropsy.
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System − Unclassified).

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 reliable with a Klimisch score of 1.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
exposure considerations
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity
The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.
Following a sighting test at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test item, as a solution in arachis oil BP, 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.
There were no deaths nor signs of systemic toxicity. All animals showed expected gains in body weight. No abnormalities were noted at necropsy.
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System − Unclassified).


 


Acute inhalation toxicity
The study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.


 


Acute dermal toxicity
The study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure.

Justification for classification or non-classification

No mortality was observed at up to 2,000 mg/kg bw when the substance was investigated for its toxicity following an acute exposure via the oral route. Therefore, it does not meet the criteria for classification in accordance with Regulation (EC) No 1272/2008.


In accordance with REACH, Annex VIII, Column 2, it was not required to investigate the acute toxicity of the substance following an exposure via inhalation or the dermal route.