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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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 or test system 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:
other: Salivation, stained and wet perineal are, stained face and weakness 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
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.