Registration Dossier

Administrative data

Description of key information

Oral - LD50 = 12232 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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: ChR-CD
Sex:
male
Details on test animals and environmental conditions:
IN-LIFE DATES: From: 1980-05-14 To: 1980-08-14
Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
10, 11, 12 and 14 g/kg bw
No. of animals per sex per dose:
10 males/dose
Control animals:
no
Statistics:
Probit analysis using the methods of Finney
Preliminary study:
Yes
Sex:
male
Dose descriptor:
LD50
Effect level:
12 232 mg/kg bw
Based on:
test mat.
95% CL:
> 11 429 - < 13 555
Mortality:
10,000 mg/kg bw - 0% mortality
11,000 mg/kg bw - 40% mortatlity
12,000 mg/kg bw - 40% mortality
14,000 mg/kg bw - 80% mortality
Clinical signs:
Salivation, stained and wet perineal are, stained face and weakness observed at most dose levels
Body weight:
Moderate weight loss observed at most dose levels
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) in the rat was determined to be 12232 mg/kg bw
Executive summary:

The acute oral median lethal dose (LD50) in the rat was determined to be 12232 mg/kg bw

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
12 232 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
April 16, 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
The model is been assessed according to the OECD principles for the validation of QSAR, to generate a transparent, understandable, reproducible and verifiable result.
Qualifier:
according to
Guideline:
other:
Version / remarks:
ECHA Guidance on information requirements and chemical safety assessment - Chapter R.06: QSARs and grouping of chemicals
Principles of method if other than guideline:
Prediction was calculated using QSAR Toolbox v.4.2 Database version: 4.2
Species:
rabbit
Dose descriptor:
LD50
Effect level:
2 460 mg/kg bw
Based on:
test mat.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute dermal median lethal dose (LD50) in the rabbit was determined to be 2460 mg/kg bw
Executive summary:

The acute dermal median lethal dose (LD50) in the rabbit was determined to be 2460 mg/kg bw

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 460 mg/kg bw

Additional information

Justification for classification or non-classification

Classification with regard to acute oral and dermal toxicity is not justified based on the observed/predicted lack of mortality at a dose level of 2000 mg/kg or greater.

Classification according to the criteria of Regulation 1272/2008/EC (CLP) and Directive 67/548/EEC (DSD) is therefore not indicated.