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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 male rats = 30.1 ml/kg (26.8 g/kg) = 26800 mg/kg.bw expert judgement: Not subject to classification according to GHS);
LD50(dermal, rat, 24h) > 2000 mg/kg.bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
26 800 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
well performed, according to OECD guideline 402

Additional information

All present studies for C12 -14 Alkyl Glycidyl Ether are used for read-across to avoid duplicate tests due to limited available information of C13 -15 Alkyl Glycidyl Ether.

Acute toxicity: oral

Based on the results (Dr. U. Hackenberg, 1974), it is deduced that oral LD50 male rats = 30.1 ml/kg (26800 mg/kg.bw.). In this study, four groups each of 10 male rats and one group of 20 male rats were treated with the undiluted substance. The application volume was 17.8 mL/kg, 23.7 mL/kg, 27.4 mL/kg and 31.6 mL/kg, respectively.

Mortality and clinical signs were observed during 14 days after treatment. No deaths occurred in the control group and test groups treated with 17.8 mL/kg, 23.7 mL/kg and 27.4 mL/kg. 16 out of 20 rats died in the highest treated group (31.6 mL/kg) during the course of the study.

Loss of body weight was noted in the 31.6 mL/kg treated group during the first week of observation, but the surviving animals did not recover completely at the end of the observation period compared with the control animals.

For the 31.6 mL/kg treated animals, red discoloration of the stomach with hemmorhage was noted at the unscheduled necropsy in 12 out of 16 animals. Blood in the stomach was observed in 5 animals. Red discoloration of the small intestine with hemmorhage was observed in 10 animals and blood in the small intestine was seen in 12 animals.

Acute toxicity: inhalation

As the test material is a liquid with high boiling point (> 300 degree C) and low vapour pressure (< 1 Pa at 25 degree C), it is reasonable to expect that the inhalation route will not be a significant exposure route to the test material. Thus, there is no additional test requirement for this endpoint.

Acute toxicity: dermal

A GLP dermal test (J. R. Jones, 1990) following OECD guideline 402 showed that no signs of toxicity were observed following a single, 24 hours, occluded application of the test material to intact Sprague-Dawley strain rats’ skin for 24 hrs, at a dose level of 2000 mg/kg bodyweight. The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg.bw.


Justification for selection of acute toxicity – oral endpoint
Only one study is available.

Justification for selection of acute toxicity – inhalation endpoint
As the test material is a liquid with high boiling point (> 300 degree C) and low vapour pressure (< 1 Pa at 25 degree C), it is reasonable to expect that the inhalation route will not be an significant exposure route to the test material. Thus, there is no additional test requirement for this endpoint.

Justification for selection of acute toxicity – dermal endpoint
guideline test with GLP

Justification for classification or non-classification

Based on the results of present studies (LD50(oral, male rat) = 26800 mg/kg.bw; LD50(dermal, rat, 24h) > 2000 mg/kg.bw), it can be concluded that test substance shall not be classified under the CLP (Regulation EC No. 1272/2008).