Carbonic acid, ethyl methyl ester

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

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:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

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"): MEC
Description: clear colourless liquid
Batch number: 00925
Date received: 11.27.2000
Storage conditions: stored at room temperature in the dark until 01.16.2001, thereafter at approximately 4 °C in the dark

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".

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male

Details on test animals and environmental conditions:

Twenty-one male albino Dunkin Hartley guinea pigs were supplied by David Hall Limited, Burton-on-Trent, Staffordshire, UK.
animal weight at start of study: 300 - 328 g

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

arachis oil

Induction 2

Concentration / amount:

Test material selected for the intradermal induction stage of the main study was 1 % (v/v) in arachis oil; undiluted test material was selected for the main study topical induction; concentrations of the test material selected for the main study topical challenge were 50 % and 25 % (v/v) in arachis oil.

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

arachis oil

Challenge 2

Concentration / amount:

Test material selected for the intradermal induction stage of the main study was 1 % (v/v) in arachis oil; undiluted test material was selected for the main study topical induction; concentrations of the test material selected for the main study topical challenge were 50 % and 25 % (v/v) in arachis oil.

No. of animals per dose:

2 for intradermal injections (0.1 mL/injection site)
2 for Topical Induction
2 for Topical challenge
15 for main study (10 test animals, 5 control animals)

Results and discussion

In vivo (non-LLNA)

Results

Hours after challenge:

24

Group:

test chemical

Dose level:

25 % to 50 % (v/v) test material

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: . Hours after challenge: 24.0. Group: test group. Dose level: 25 % to 50 % (v/v) test material. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Skin reactions noted at the challenge sites of the test group animals will be attributed to skin sensitisation, providing that the reactions of equal severity are not seen at the corresponding challenge sites of the control group animals. If skin reactions are seen at the challenge sites of the control group animals, these will be due ro skin irritation, and therefore only skin reactions of greater severity in the test group animals will be attributed to skin sensitisation.

Intradermal induction: Discrete or patchy to moderate and confluent erythema was noted at the induction sites of the test group animals with discrete or patchy erythema noted at the induction sites of control group animals.

Topical induction: Discrete or patchy to moderate and confluent erythema was noted at the induction sites of test and control group animals one hour after dressing removal with discrete or patchy erythema persisting 24 hours after patch removal. Bleeding from the intradermal injection sites was also noted in test and control group animals after dressing removal.

Topical Challenge: 50 % v/v in Arachis Oil BP, no skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48 -hour observations. 25 % v/v in Arachis Oil BP, no skin reactions were noted at the challenge sites of the test control group animals at the 24 or 48 -hour observations.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

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

Conclusions:

The test material produced a 0% (0/10) sensitisation rate and was classified as a non-sensitiser to guinea pig skin under the conditions of the test. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations Commissions Directive 93/21/EEC. No classification according to the classification criteria in REGULATION (EC) No 1272/2008, Chapter 3.4. Respiratory or skin sensitisation (table 3.4.2).