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

Study period:

Feb 02 - Mar 09, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was performed in compliance with the Good Laboratory Practice (GLP) regulations (revised in 1997, ENV/MC/CHEM(98)17). The method followed that described in the OECD Guidelines for Testing of Chemicals, Updated Guideline No 406 Skin Sensitisation (adopted 17 Julyl 1992).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

None

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:

Identification: MEC
Name: Ethyl Methyl Carbonate

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 300 to 328g
- Housing: singly or in pairs in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

arachis oil

Induction 2

Concentration / amount:

Intradermal Induction:
1% and 5% v/v MEC in distilled water

Topical Challenge:
50% v/v MEC in arachis oil

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

arachis oil

Challenge 2

Concentration / amount:

Intradermal Induction:
1% and 5% v/v MEC in distilled water

Topical Challenge:
50% v/v MEC in arachis oil

No. of animals per dose:

Total: 21 females
Pre-test: 6 females
Control group: 5 females
Test group 10 females

Details on study design:

RANGE FINDING TESTS:
- intradermal injection: 1, 5 % v/v given to two animals in distilled water
- topical applications, no pretreatment: undiluted, 75, 50, 25 % v/v given to two animals in arachis oil
- topical applications, pretreatment with FCA: undiluted, 75, 50, 25 % v/v given to two animals in arachis oil

MAIN STUDY
lntradermal Induction 1 % v/v in arachis oil
Topical Induction undiluted as supplied
Topical Challenge 50% and 25% v/v in arachis oil

Positive control substance(s):

yes

Remarks:

from other study

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

50 %

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no signs of toxicity

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs of toxicity.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

50 %

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no signs of toxicity

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs of toxicity.

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

25 %

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no signs of toxicity

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs of toxicity.

Results 4

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

25 %

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no signs of toxicity

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs of toxicity.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Under the conditions of the test, the test material produced a 0% (0/10) sensitisation rate and was classified as a non-sensitiser to guinea pig skin.
The test material did not meet the criteria for classification as a sensitiser according to CLP. No symbol and risk phrase are required

Executive summary:

Purpose

The purpose of this GPMT assay was to identify the contact allergenic potential of the test item. This study should provide a rational basis for risk assessment to the sensitising potential of the test item in man.

Study Design

The test item was evaluated for skin sensitizing properties in the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969).
Ten test and five control animals were used for the study. Two phases were involved in the main study: an induction of a response by intradermal injection and topical application and a topical challenge of that response. Based on the results of sighting tests. the concentrations of test material for the induction and challenge phases were selected as. lntradermal Induction 1 % v/v in arachis oil Topical Induction undiluted as supplied Topical Challenge 50% and 25% v/v in arachis oil

Results

Skin Reactions Observed After lntradermal induction Discrete or patchy to moderate and confluent erythema was noted at the induction sites of test group animals with discrete or patchy erythema noted at the induction sites of control group ati:mals. Skin Reactions Observed After 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 dierete or patchy erythema persisting 24 hours after patch removal. Bleeding from the intraderlnal injection sites was also noted in test and control group animals one hour after dressing removal. Skin Reactions Observed After Topical Challenge No skin reactions were noted at the challenge sites of the lest or control group animals. 50% v/v in Arachis Oil No skin reactions were noted at the challenge sites of the lest or control group animals at the 24 or 48-hour observations. 25% v/v in Arachis Oil No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48-hour observations..
The clinical behavior of the guinea pigs was normal during the experimental part. All animals survived the experimental part.

The body weight development corresponded to that of the animals of the vehicle group.

Reactions after challange:

Induction with	Challenge with	Positive/animals (24 h after challange)	Positive/animals (48 h after challange)	Positive/animals (overall)
test substance	test substance	0/10	0/10	0/10

Conclusion

Under the conditions of the test, the test material (MEC) produced a 0% (0/10) sensitisation rate and was classified as a non-sensitiser to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to CLP. No symbol and risk phrase are required