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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The LD50 of the substance is > 6400 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:
August-September 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: CFY
Sex:
male/female
Details on test animals or test system and environmental conditions:
no data
initial average body weights between males 102-105 g, females 96-101 g
Animals were fasted overnight prior to dosing
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40% in corn oil

MAXIMUM DOSE VOLUME APPLIED: 40 mL/kg bw
Doses:
16 g/kg bw
No. of animals per sex per dose:
5 males + 5 females
Control animals:
yes
Remarks:
treated with 40 ml/kg bw corn oil
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: on day 0 , 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs frequency not indicated
Statistics:
NA
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 16 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 400 mg/kg bw
Based on:
act. ingr.
Mortality:
none
Clinical signs:
other: piloerection, hunched posture and diarrhea (in one female) shortly after dosing (until day 6)
Gross pathology:
no abnormalities (similar to controls)
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the substance is > 6400 mg/kg bw
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
6 400 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

The acute inhalation study is waived, because the inhalation route is not relevant for this substance.

The acute dermal study is waived based on the absence of systemic effects in the acute oral toxicity study and the available studies via the dermal route.

Justification for classification or non-classification

Based on the information available the substance does not need to be classified according to Regulation (EC) No 1272/2008 (CLP).