Carbonic acid, ethyl methyl ester

Eye irritation

Administrative data

Endpoint:

eye 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 6.

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: 11 Feb 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Six New Zealand White rabbits were supplied by David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
Sex of tested animals: 2 females, 4 males
Animal weight at start of the study: 2.68 - 3.16 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 (RABMA Rabbit Diet, Special Diet Services Ltd., WItham, Essex, U.K.) ad libitum; temperature 17-22 °C, relative humidity 44-56 %; air exchange rate ca. 15 times/h; light-darkness-period: 12 h/12 h (electric lighting)

Test system

Vehicle:

unchanged (no vehicle)

Remarks:

instilled into conjunctival sac of the eye

Controls:

no

Amount / concentration applied:

0.1 mL of undiluted test substance instilled in conjunctival sac of the eye of one rabbit. Because of initial pain reaction of the first rabbit, the five additional animals were instilled with one drop of local anaesthetic ("Ophthaine, 0.5 % proxymetacaine hydrochloride, E.R. Squibb & Sons Limited, Hounslow, Middlesex, U.K.) 1-2 minutes before treatment in order to minimise the pain.

Duration of treatment / exposure:

upper and lower eyelids were held together for about one second immediately after instillation

Observation period (in vivo):

1, 24, 48 and 72 h after treatment

Number of animals or in vitro replicates:

6

Results and discussion

In vivo

Results

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Score:

4.8

Reversibility:

fully reversible within: 24 to 48 h

Remarks on result:

other: Minimal irritant (Class 3 on a 1 to 8 scale)

Irritant / corrosive response data:

Group mean scores for ocular irritation: 4.8 (1 h), 0.3 (24 h), 0.0 (48 h), 72 h (0.0)
Individual total scores: 1 h (4, 13, 4, 2, 2, 4), 24 h (2 and all other animals 0), 48 h (all animals 0), 72 h (all animals 0)

No corneal effects were noted during the study.
Iridial inflammation was noted in one treated eye one hour after treatment. No other iridial effects were noted.
Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment. Minimal conjunctival redness persisted in one treated eye at the 24-hour observation.

Treated eyes appeared normal 24 to 48 h after treatment.

Applicant's summary and conclusion

Interpretation of results:

other: MINIMAL IRRITANT

Remarks:

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

Conclusions:

Ethyl methyl carbonate produced a maximum group mean score of 4.8 and was classified as a MINIMAL IRRITANT (CLASS 3 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified Kay and Calandra classification system. The mean values following grading at 24, 48 and 72 hours after instillation of the test material are below the the scores necessary for a classification as Category 2 (Irritating to eyes). Reference: REGULATION (EC) No 1272/2008, Chapter 3.3. Serious eye damage/eye irritation (Table 3.3.2).