Registration Dossier

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: acceptable study report on the acute inhalative toxicity determined for male and female rats.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970

Materials and methods

Principles of method if other than guideline:
Inhalation studies were carried out according to methods from Farbenfabriken Bayer A.G., Werk Wuppertal-Elberfeld, Germany.
GLP compliance:
no
Test type:
other: acute toxicity inhalative

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): "DIÄTHYLCARBONAT"
- Analytical purity:
German, original statement: "Für die Untersuchungen wurde eine chemisch reine Verbindung verwendet."
English, original statement translated: For the examinations a chemically pure compound was used.

Test animals

Species:
rat
Strain:
other: Male and female Wistar-II-rats (weight 160-200 g), male and female Wistar-II-SPF-rats (weight 130-150 g) from the breeder Winkelmann, Kirchborchen, Germany;
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
other: probably whole body
Vehicle:
air
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Gas chromatography; Details on methodology see under 8 Analytical methods in this IUCLID dossier
Duration of exposure:
7 h
Remarks on duration:
on day 1
Concentrations:
4h on day 1: 17.75 mg/L (males), 18.30 mg/L (females);
7 h on day 1: 19.50 mg/L (males, females);
No. of animals per sex per dose:
20
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: NOEC
Effect level:
19.5 mg/L air
Based on:
test mat.
Exp. duration:
7 h
Remarks on result:
other: The endpoint NOEC was not mentioned in the study report and was assumed by the author of this IUCLID dossier as at this concentration no symptoms or deaths occurred.
Mortality:
0
Clinical signs:
other: none

Any other information on results incl. tables

No signs of toxicity or irritation were observed in any animal, nor died any rats. No changes in the inner organs of the animals were seen. According to these results the author of this IUCLID dossier assumed that the NOEC for the test substance diethyl carbonate was 19.5 mg/L.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
According to the results of an acute toxicity inhalation study of the test substance diethyl carbonate in male and female rats, no signs of toxicity or irritation were observed at a concentration of 19.5 mg/L. At this concentration no deaths occurred. Regarding these results, the author of this IUCLID dossier assumed that the NOEC of diethyl carbonate (acute toxicity inhalation) is 19.5 mg/L. It can therefore be concluded that the substance should not be classified in any of the four categories. As the NOEC is assumed to be 19.5 mg/L it can be concluded that the corresponding LC50 should be much greater than 19.5 mg/L which represents the upper limit for classification in category 4 (10 < LC50 ≤ 20 mg/L, Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures (2009)).