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Administrative data

Description of key information

In an acute oral toxicity study (similarly to OECD Guideline 401) a LD50 value of 121 mg/kg bw was determined (Industrial Bio-test Laboratories, 1969). In an acute dermal toxicity study (similarly to OECD Guideline 404), a LD50 value of 890 mg/kg bw was determined (OECD SIDs, 2005). 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
121 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
20 000 mg/m³
Quality of whole database:
Not sufficient enough for C&L determination.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
890 mg/kg bw

Additional information

Acute toxicity: oral

Five male rats were administered with a single dose the test substance (gavage) in dose concentrations of 68, 100, 147, 215 mg/kg bw/d. The acute oral toxicity study reported was performed similarly to OECD Guideline 401. Mortality and all observed clinical symptoms were recorded for 14 days after test substance administration. At the end of the observation period gross autopsy was performed.

All animals showed signs of intoxication including hyperactivity, tremor, convulsion, dyspnea, prostration within 4 hours post dosing. Mortality occurred within 4 hours post dosing:

Dose group 68 mg/kg bw: no deaths but signs of intoxication; recovery within 2 days

Dose group 100 mg/kg bw: mortality: 2/5; survivors recovered within 2 days

Dose group147 mg/kg bw: mortality: 3/5; survivors recovered within 6 days

Dose group 215 mg/kg bw: mortality 5/5.

The LD50 value determined was 121 mg/kg bw.

Acute toxicity: inhalation

Based on the data available, determination of classification and labelling for the test substance cannot be reliable although the results could imply that the substance has no potential to be C&L for acute toxicity inhalation. Three different limit tests showed a LC50 values between 0.22 – 1.78 mg/L. Another IUCLID record which was based only on a summary table in a report showed a LC50 value of > 20 mg/L (no limit test). In most of the tests irritation to mucous membrane was reported.

Acute toxicity: dermal

By dermal application, LD50 values of 890 - 1380 mg/kg for rabbits were determined (OECD SIDs; Bio Fax, 1969).
Considering the worst case option, a LD50 value of 890 mg/ kg bw was taken for C&L.


Justification for selection of acute toxicity – oral endpoint
Most reliable available data.

Justification for selection of acute toxicity – inhalation endpoint
The only no limit test available.

Justification for selection of acute toxicity – dermal endpoint
Most reliable available data.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC):

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified for acute oral toxicity as T; R25 and for acute dermal toxicity as Xn; R24, under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008:

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified for acute oral toxicity as Acute Tox. 3; H301: Toxic if swallowed and for acute dermal toxicity as Acute Tox. 3 H311: Harmful in contact with skin, under Regulation (EC) No. 1272/2008, as amended for the fifth time in Directive EC 944/2013.