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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:
from 1998-02-18 to 1998-04-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Version / remarks:
cited as: Directive 92/69/EEC method B4, from 29 Dec 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted: 17 Jul 1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
-
EC Number:
429-990-6
EC Name:
-
Molecular formula:
Not applicable as multi-const. substance. Please refer to IUCLID section 1.2 for details on constituents.
IUPAC Name:
2-[(2R)-2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethan-1-ol; 2-[(2R)-2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethyl 2-[(2S)-2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethyl carbonate; 2-[(2S)-2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethan-1-ol; bis{2-[(2S)-2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethyl} carbonate; methyl 2-[(2R)-2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethyl carbonate; methyl 2-[(2S)-2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethyl carbonate
Test material form:
liquid: viscous

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd. Margate
- Age at study initiation: 10 to 14 weeks old
- Weight at study initiation: 2.35 to 2.58 kg
- Housing: floor-pens, minimum floor area of 0.6 sq m
- Diet: ad libitum, SQC TRB Rabbit Diet 9603 (pelleted) from Harlan Teklad. Bicester
- Water: tab water, ad libitum
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 22 °C.
- Humidity (%): 40 - 80 %
- Air changes (per hr): 10 air changes per hour
- Photoperiod: 12 hours light, from 6.00 a.m to 6.00 p.m.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount applied : 500 mg
Duration of treatment / exposure:
4 h
Observation period:
15 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 10x8 cm
- % coverage: not specified

REMOVAL OF TEST SUBSTANCE
- Washing: not performed
- Time after start of exposure: 4 hours

SCORING SYSTEM: Macroscopic Dermal Grading System based on Draize (erythema /edema score).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean)
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean)
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean)
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.8
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Max. duration: 8 d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean)
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Max. duration: 8 d; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 14 days. Based on the Regulation (EC) No 1272/2008 (CLP) , the test item is considered to be a non-irritant to the skin of the rabbit based on both, the erythema and edema score.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A single semi-occluded application of Incozol LV to intact rabbit skin for four hours caused marked inflammation and other dermal changes including petechial haemorrhage. However, all overt signs of irritation resolved within fourteen days of treatment. Thus, based on the Regulation (EC) No 1272/2008 (CLP), the test item is considered to be a non-irritant to the skin of the rabbit based on both, the erythema and edema score.
Executive summary:

A study was conducted according to OECD TG 404 and Directive 92/69/EEC method B.4 to assess the irritation or corrosion caused to the intact dorsal skin of rabbit following a single (4 hour) semi-occluded topical application of Incozol LV. Therefore, 3 New Zealand White rabbits were administrated to the test item Incozol LV. A single semi-occluded application of Incozol LV to intact rabbit skin for four hours caused marked inflammation and other dermal changes including petechial haemorrhage. However, all overt signs of irritation resolved within fourteen days of treatment. Thus, based on the Regulation (EC) No 1272/2008 (CLP), the test item is considered to be a non-irritant to the skin of the rabbit based on both, the erythema and edema score.