Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Oral:
- female rats, LD50: 3850 mg/kg bw
- female mice, LD50: 5140 mg/kg bw (supporting data)
- female rats, LD50 (triglyme): 5390 mg/kg bw (supporting data)
- female rats, LD50 (diglyme): 4760 mg/kg bw (supporting data)
- female rats, LD50 (monoglyme): 5370 mg/kg bw (supporting data)
- male rats, LD50 (2-ME): 2460 mg/kg bw (supporting data)
- rats, LD50 (EMDE): ca.6500 mg/kg bw (supporting data)
Inhalation:
- male/female rats, LC0 (diglyme; 7h exposure): 11 mg/L -> 19.3 mg/L (4h calculated exposure)
- male/female rats, LC0 (monoglyme; 1h exposure): 240 mg/L -> 60 mg/L (4h calculated exposure)
- rats, LC50 (monoglymer; 6h exposure): > 20 mg/L
Dermal:
- male rats, LD50 (triglyme): > 6900 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:
3 850 mg/kg bw
Quality of whole database:
reliable and robust; total 5 studies/reports are available on target or source chemicals; the results are in line indicating low oral toxicity.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Value:
mg/m³ air
Quality of whole database:
reliable and robust; total 3 studies/reports are available on source chemicals; the results are in line indicating low inhalation toxicity.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
reliable and robust; the result obtained in the available study is in line with observed low (no) toxicity in oral and inhalation studies.

Additional information

The acute toxicity of tetraglyme can reasonably be derived based on the experimental data and on the read-across approach using low molecular glymes as source chemicals.

The underlying scientific rationale is that target chemical belongs to the homologues series of glymes and thus to a “chain length category”, where there is an incremental increase in the number of CH2CH2O units. Based on the basic concept of “chain length category”, the same toxic mode of action can be assigned for each category members and the use of toxicity data of other glyme members (mono-, di-, triglymes) for read-across purpose to tetraglyme is justified (see for more information “Assessment of the validity of the analogue approach”).

Total five oral studies, three inhalation studies and one dermal studies were used for the assessment of acute toxicity of tetraglyme. Based on the study results no acute toxicity could be derived.


Justification for selection of acute toxicity – oral endpoint
Scientifically well performed study

Justification for selection of acute toxicity – inhalation endpoint
Scientifically well performed study

Justification for selection of acute toxicity – dermal endpoint
Scientifically well performed study

Justification for classification or non-classification

Based on the available data no classification is warranted according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).