Registration Dossier

Administrative data

Description of key information

Oral:
- female rats, LD50: 5370 mg/kg bw
- female rats, LD50: > 4000 mg/kg bw
- female mice, LD50: 2526 mg/kg bw
Inhalation:
- male/female rats, LC0 (1h exposure): 240 mg/L -> 60 mg/L (4h calculated exposure)
- rats, LC50 (6h exposure): > 20 mg/L
- female rats, LC0 (1h exposure): 247 mg/L -> 61.8 mg/L (4h calculated exposure)
Dermal:
- female rats, LD50: > 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
5 370 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
5 000 mg/kg bw

Additional information

Oral:

One key study plus supporting information is available in rats and mice for the acute oral toxicity of Ethylene glycol dimethyl ether. The most reliable LD50determined was 5370 mg/kg bw for female Wistar rats. All results are shown in the “Short description of key information” field.

Inhalation:

A number of studies/supporting information is available for the acute inhalation toxicity in rats. The LC50 for 6 hours exposure is reported to be greater than 20 mg/L. Additionally two studies showed that the LC0 for 1 hour exposure to a saturated Ethylene glycol dimethyl ether atmosphere is set at 240 mg/L air. This leads to a calculated LC0value of 60 mg/L for 4 hours exposure.

Dermal:

There is one well performed and reported dermal toxicity study in female Wistar rats available. The LD50was reported to be > 5000 mg/kg bw. This information is supported by a restricted reported dermal toxicity study in female rabbits which led to a LD50of approximately 2000 mg/kg bw.

Justification for classification or non-classification

Due to the findings described above (LD50 oral in rats 5370 mg/kg bw, LC50 inhalatory in rats greater than 20 mg/L, LD50 dermal in rats greater than 5000 mg/kg bw) Ethylene glycol dimethyl ether has not to be classified as acute toxic.

However, the substance is Annex 1 listed and classified as "harmful by inhalation " (R20).