Registration Dossier

Diss Factsheets

Administrative data

Description of key information

The acute toxicity of the test item was investigated in an acute toxicity study on rats. The test animals showed no clinical signs (and no mortality) up to the limit dose after oral administration. Hence, the LD50 is above 2000 mg/Kg bw.

The subsequent evaluation on the necessity of a acute test via a second route was done in accordance with Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance, Version 6.0, July 2017, p 374f.

A DermWin calculation shows a dermally absorbed dose of 0.000012 to 0.00016 mg/cm2/event. Based on the very low dermally absorbed rate and the absence of systemic effects after acute oral administration, a study on acute dermal toxicity is not required.

Furthermore, based on the lack of systemic toxicity after acute oral adminsitration, it is more than evident that an acute study on inhalation would not show any different outcome. Therefore, and due to animal welfare reasons a study on acute inhalation is not required.

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:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
doses applied exceed the limit dose
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
not specified
Details on test animals or test system and environmental conditions:
Temperature:24-25°C
Humidity: 60-75 %
Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
5860, 7620, and 9900 mg/kg bw
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 9 900 mg/kg bw
Based on:
test mat.
Mortality:
no mortality was observed
Clinical signs:
no clinical signs have been reported
Body weight:
no effects have been reported
Gross pathology:
no abnormalities have been reported
Other findings:
no other findings
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 oral (rat) exceeds 9900 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
9 900 mg/kg bw

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 provided information there is no need for classification according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures.

Categories Display