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Administrative data

Description of key information

In a reliable acute toxicity study the substance was administered to female Wistar rats (5 animals/dose) by oral gavage at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was as expected and no abnormalities found at macroscopic post-mortem examination.The oral LD50 is >2000 mg/kg bw.

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:
21 February 2018 - 19 March 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
yes
Remarks:
Based on current GLP guidance, at the time of issue/approval the study plan did not contain sufficient information with regards test item identification. The required information is however included in the final study report.
GLP compliance:
yes
Test type:
fixed dose procedure
Specific details on test material used for the study:
Batch: 1013Q17761
Purity: 100%
Physical state/Appearance: white powder
Expiry Date: 25 June 2018
Storage Conditions: room temperature in the dark
Species:
rat
Strain:
Wistar
Remarks:
(RccHan™:WIST)
Sex:
female
Details on test animals and environmental conditions:
The females were nulliparous and non-pregnant. Acclimatization period of at least 5 days.
Route of administration:
oral: gavage
Vehicle:
arachis oil
Doses:
A single animal was administered with 300 mg/kg bw.
In the absence of toxicity at a dose level of 300 mg/kg, an additional animal was administered with 2000 mg/kg bw.
In the absence of toxicity at a dose level of 2000 mg/kg, an additional group of animals (n=4) was administered with 2000 mg/kg bw.
No. of animals per sex per dose:
One animal at 300 mg/kg bw.
5 animals at 2000 mg/kg bw.
Control animals:
no
Preliminary study:
There were no deaths. There were no signs of systemic toxicity were noted during the observation period. The animal showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
Hunched posture was in noted four animals 1 and 2 hours after dosing. No other signs of toxicity were noted.
Body weight:
All animals showed expected gains in body weight over the observation period.
Gross pathology:
No abnormalities were noted at necropsy.
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 is >2000 mg/kg bw.
Executive summary:

In an acute toxicity study the substance was administered to female Wistar rats (5 animals/dose) by oral gavage at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was as expected and no abnormalities found at macroscopic post-mortem examination. The oral LD50 is >2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Sufficient to address requirements.

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

Justification for classification or non-classification

Based on the findings of a reliable acute oral toxicity study conducted on the substance, classification of the substance is not justified.