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Description of key information

The Acute oral study was designed to meet the OECD guideline No 420, the study produced an LD50 value of greater than 2000 mg/kg bw. The test material does not meet the criteria for classification according to Council Directive 67/548/EEC or Regulation (EC) No 1272/2008.
The acute dermal study was carried out according to OECD guidelines No 402 and method B 3 of Commission Directive 2004/73/EC. The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. The test material does not meet the criteria for classification according to Council Directive 67/548/EEC or Regulation (EC) No 1272/2008.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Acute Oral Study

Introduction. 

The study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the following:

·       OECD Guidelines for Testing of Chemicals No 420 “Acute Oral Toxicity - Fixed Dose Method” (adopted 17 December 2001)

·        Method B1 bis Acute Toxicity (Oral) of Commission Directive 2004/73/EC

Method:

Following a sighting test at dose levels of 2000 mg/kg, an additional four fasted females were given a single oral dose of undiluted test material at a dose level of 2000 mg/kg bw. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

 

Results:

Mortality. There were no deaths.

 

Clinical Observations. There were no signs of systemic toxicity.

 

Bodyweight. All animals showed expected gains in bodyweight.

 

Necropsy. No abnormalities were noted at necropsy.

 

Conclusion:

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight. The test material does not meet the criteria for classification according to Council Directive 67/548/EEC or Regulation (EC) No 1272/2008.

Acute Dermal Toxicity

Introduction:

The study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the following:

·       OECD Guidelines for the Testing of Chemicals No. 402 “Acute Dermal Toxicity” (adopted 24 February 1987)

·       Method B3 Acute Toxicity (Dermal) of Commission Directive 92/69/EEC

Method:

A group of ten animals (five males and five females) was given a single, 24-hour, semi-occluded dermal application of the undiluted test material to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality. There were no deaths.

Clinical Observations. There were no signs of systemic toxicity.

Dermal Irritation. There were no signs of dermal irritation.

Bodyweight. All animals showed expected gains in bodyweight over the study period.

Necropsy. No abnormalities were noted at necropsy.

Conclusion:

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. The test material does not meet the criteria for classification according to Council Directive 67/548/EEC or Regulation (EC) No 1272/2008.

Justification for classification or non-classification

The substance Enordet 0241 does not meet the classification criteria according to DSD or the CLP regulations for acute oral or acute dermal toxicity and is therefore not classified.