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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:
9 Apr 1990 to 17 Apr 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: J. Europ. Commun. L 251, 27, 106-108
Version / remarks:
19. September 1984
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerides, castor-oil mono-, di- and tri-
EC Number:
294-589-3
EC Name:
Glycerides, castor-oil mono-, di- and tri-
Cas Number:
91744-27-3
Molecular formula:
C21H40O5 – C57H104O9
IUPAC Name:
Glycerides, castor-oil mono-, di- and tri-
Test material form:
liquid
Specific details on test material used for the study:
- Name as cited in study report: Loxiol G11
- Charge: 0419-0-040

Test animals

Species:
rabbit
Strain:
other: Kleinrussen, Chbb:HM
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Fa. Thomae, Biberach / Germany
- Age at study initiation: 19-23 months
- Weight at study initiation: ca. 2670 g
- Housing: Individually in Rabbit batteries of Fa. Heinkel, 7343 Kuchen/ Germany
- Diet: Altromin-Haltungsdiät 2023 Fa. Altromin GmbH, Lage/ Germany, ad libitum
- Water: Tapwater, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL undiluted substance
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
The substance is equally distributed on a patch of 6 cm². The adhesive, air and watervapor permeable patch is fixed with an adhesive bandage.

OBSERVATION TIME POINTS
1, 24, 48 and 72 hours. Reversibility of the reactions was checked for 7 days.

SCORING SYSTEM:
- Method of calculation: The scoring criteria were according to guidance 84/449/EWG (EC document L251/108):

Erythema and scaps
0 = No erythema
1 = Very mild erythema
2 = Well defined erythema
3 = Moderate to severe erythema
4 = Severe erythema (severe redness) to mild saps formation (thorough injury)

Edema
0 = No edema
1 = Very mild edema
2 = Mild edema (the borders are visible due to a clear swelling)
3 = Moderate edema (swelling around 1 mm)
4 = Severe oedema (swelling exceeding 1 mm and exceeding the site of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
All reactions were reversible in 7 days.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met

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