Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Follows a guideline similar to OECD 404 and is performed under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF), Testing guidelines for toxicology studies, 59 NohSan No. 4200 (Jan.28, 1985)
Principles of method if other than guideline:
The method used is similar to OECD guideline 404.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.47 - 2.75 kg
- Housing: Housed individually in suspended metal cages.
- Diet: Spillers Rabbit diet ad libitum
- Water: mains drinking water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 20
- Humidity (%): 41-56
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml test material
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6 (4 females; 2 males)
Details on study design:
A day prior to the test, each test animal was clipped free of fur from the dorsal/flank area with clippers. Animals with healthy intact skin were selected for the study. On the day of the test, 0.5ml of test material was introduced under a 2.5 cm x 2.5 cm gauze patch and placed on the shaved area. The patch was kept in position using a strip of surgical adhesive tape (BLENDERM: approx size - 2.5 cm x 4.0 cm). To prevent the test animals from interfering with the patches, the trunk of each test animal was wrapped in an elasticated corset and animals were returned to their cages for the duration of the exposure period.

After the exposure period (4 hours), the corset and patches were removed from each test animal and residual test material was removed using cotton wool soaked in diethyl ether. One hour after removal of the patches and subsequently 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the Draize scale.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72-h
Score:
0.08
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
Scores for erythema and oedema at 24h and 72h readings were totalled for all test animals and this total was divided by 12 to give the primary irritation index of the test substance. See table 1 below ('Any other information on results incl. tables' field) for details of individual readings.

Any other information on results incl. tables

Very slight erythema was observed one hour after patch removal from one treated skin site. Very slight erythema was also observed at another treated skin site at 24 -hour and was present at the 48 -hour observation. All treated skin sites were normal at the 72 -hour observation.

Table 1. Individual skin reactions

Skin Reaction Type Observation time (hours) Individual Scores  
Female 1 Female 2 Female 3 Female 4 Male 1 Male 2 Total
Erythema / Eschar formation 1 0 1 0 0 0 0 1
24 0 0 0 0 0 1 1
48 0 0 0 0 0 1 1
72 0 0 0 0 0 0 0
Oedema formation 1 0 0 0 0 0 0 0
24 0 0 0 0 0 0 0
48 0 0 0 0 0 0 0
72 0 0 0 0 0 0 0
Sum of 24 and 72 hour readings 1
Primary Irritation Index [(Sum of 24 and 72h readings)/12] 0.08

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, ethyl methyl carbonate has been evaluated for skin irritation and a primary irritation index of 0.08 was determined, thus ethyl methyl carbonate could be considered to be a mild irritant according to the Draize classification scheme. However the effects were transient and under EU CLP and DSD classification criteria, ethyl methyl carbonate would not be considered to be irritating to the skin.