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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 15-19,2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study was performed according to following guidelines: OECD 404, EU Method B.4, EPA OPPTS 870.2500 and in compliance with to the GLP Regulations. No significant deviations can be observed from the study guidelines, which could have an impact on the performed study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
stability not reported
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Principles of method if other than guideline:
26% humidity was recorded: this is slightly outside the range specified in the study protocol. This deviation was not considered to have affected the integrity or validity of the study.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylene carbonate
EC Number:
202-510-0
EC Name:
Ethylene carbonate
Cas Number:
96-49-1
Molecular formula:
C3H4O3
IUPAC Name:
1,3-dioxolan-2-one
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Ethylene carbonate
- Purity: > 99%
- Physical state: fine crystals

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, England.
- Age at study initiation: at least 11 weeks old (adult)
- Weight at study initiation: 2.3-2.4 kg
- Housing: individually in stainless steel cages with perforated floors in Building R17 Room 10.
- Diet (e.g. ad libitum): a standard laboratory rabbit diet (Special Diet Services STANRAB (P) SQC pellet), ad libitum
- Water (e.g. ad libitum): potable water ( Anglian) for human consumption, ad libitum.
- Acclimation period: min.5d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-20.5°C
- Humidity (%): 26-36 %
- Photoperiod (hrs dark / hrs light): 12h dark/12h light


IN-LIFE DATES: From: 15 Feb 2000 To: 19 Feb 2000

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: OECD 404: untreated area of the test animal serves as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
-3min, 1h, 4h
Observation period:
4d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: app.25 mm x 25 mm, dorso-Iumbar region (clipped free of fur) /
- Type of wrap if used: 2-ply 25mm x 25 mm porous gauze pad, each treatment site was covered with "Elastoplast" elastic adhesive dressing.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with warm water (36 to 37°C)
- Time after start of exposure: 3 min, 1 and 4h


SCORING SYSTEM: observation
Draize Evaluation of Dermal Irritation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: 3 min, 1 and 4 h exposure (intact skin), no dermal irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: 3 min, 1 and 4 h exposure (intact skin), no dermal irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: 3 min, 1 and 4 h exposure (intact skin), no dermal irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: 3min, 1 and 4 hours exposure (intact skin), no dermal irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: 3 min, 1 and 4 h exposure (intact skin), no dermal irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: 3 min, 1 and 4 h exposure (intact skin), no dermal irritation
Irritant / corrosive response data:
There were no signs of toxicity or ill health in any rabbit during the observation period. (on day 1, 2, 3 or 4)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A single semi-occlusive application of JEFFSOL Ethylene Carbonate (ultra pure grade) to intact rabbit skin for four hours elicited no dermal irritation.
JEFFSOL Ethylene Carbonate (ultra pure grade) will not require labelling with the risk phrase R38, "Irritating to skin", in accordance with Commission Directive 93/21IEEC.