Carbonic acid, ethyl methyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: official guideline method, GLP with certificate, good documentation, identity of substance clear but no details on its purity

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Materials and methods

Principles of method if other than guideline:

The method was designed to comply with requirements of the Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF); Testing guidlines for Toxicology Studies, 59 NohSan No. 4200, January 28 1985. Details on method: Safepharm Standard Method Number JMAFF 5

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

433-480-9

EC Name:

-

Cas Number:

623-53-0

Molecular formula:

C4H8O3

IUPAC Name:

ethyl methyl carbonate

Details on test material:

Test material as stated in study report ("Sponsor's identification"): ETHYL METHYL CARBONATE
Description: colourless liquid
Date received: 02.11.1993
Storage conditions: room temperature
Container: clear glass jar

Remark of the author of this IUCLID dossier concerning the substance identity:
Every page of the copy of the study report contains an annotation referring to the data sharing agreement in place between the licensee that uses this study report and the data owner. In this data sharing agreement the identity of the chemical substance is specified with "Ethyl Methyl Carbonate - EC No. 433-480-9, CAS Nr. 623-53-0".

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Six New Zealand White rabbits were supplied by David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
Weight of the animals at the start of the study: 2.47 - 2.75 kg
Age: approximately twelve to sixteen weeks
Acclimatisation period from point of delivery: minimum of 5 d
Identification of animals: yes, on inner surface of ear and cage labels, with indelible black marker-pen

Husbandry:
metal cages, each animal kept individually; drinking water and food (Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol, U.K.) ad libitum; temperature 17-20 °C, relative humidity 41-56 %; air exchange rate ca. 15 times/h; light-darkness-period: 12 h/12 h (electric lighting)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped free of fur

Controls:

no

Amount / concentration applied:

0.5 mL of undiluted test substance

Duration of treatment / exposure:

4 h

Observation period:

1 h following the removal of the patches, and 24, 48 and 72 h later

Number of animals:

6

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Score:

0.08

Max. score:

8

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: MILD IRRITANT (Draize classification scheme)

Any other information on results incl. tables

Result of examinations:

"Very slight erythema was noted at one treated skin site one hour after patch removal. Very slight erythema developed at another treated skin site at the 24-hour observation and persisted at this treated skin site at the 48-hour observation. All treated skin sites appeared normal at the 72-hour observation.

Applicant's summary and conclusion

Interpretation of results:

other: MILD IRRITANT

Remarks:

Criteria used for interpretation of results: other: as stated in study report

Conclusions:

In the study, ethyl methyl carbonate produced a primary irritation index of 0.08 and was classified as a MILD IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

To classify the test substance as Category 2: Irritant, the values for erythema/eschar and oedema have to be in the range of >=2.3 - <=4.0 (REGULATION (EC) No 1272/2008, chapter 3.2. Skin corrosion/irritation). Since the values are below that range the substance does not need to be classified as irritating to the skin.