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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2003

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:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-propylheptyl) phthalate
EC Number:
258-469-4
EC Name:
Bis(2-propylheptyl) phthalate
Cas Number:
53306-54-0
Molecular formula:
C28H46O4
IUPAC Name:
1,2-bis(2-propylheptyl) benzene-1,2-dicarboxylate
Test material form:
other: colorless liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain / quality: New Zealand White Al1077 IN RA (SPF)
- Source: Centre Lago S.A., 01540 Vonnas, France
- ldentification: Ear tattoo
- Age at study initiation: about 6 - 7 months
- Weight at study initiation: 3.52 kg - 3.89 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet (e.g. ad libitum): Kliba-Labordiät, Provimni Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day); ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: at least 5 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
4 hour(s)
Observation period:
72 h
Number of animals:
3 (2 females, 1 male)
Details on study design:
TEST SITE
- Area of exposure: Flank of animal
- Site preparation: At least 24 hours before the beginning of the study clipping of the dorsolateral part of the trunk of the animal(s).
- Type of wrap if used: test patch (2.5 cm x 2.5 cm) was moistened with a dose of 0.5 ml of the unchanged liquid test substance.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with Lutrole and Lutrole : water (1 : 1)
- Time after start of exposure: 4 h

SCORING SYSTEM:
The evaluation of skin reactions is performed according to the guidelines:

Erythema and eschar formation
0 = No erythema
1 = Very slight erythema (barely perceptible)
2 = Well defined erythema
3 = Moderate to severe erythema
4 = Severe erythema (beet redness) to eschar formation preventing grading of erythema

Edema formation
0 = No edema
1 = Very slight edema (barely perceptible)
2 = Slight edema (edges of area well defined by definite raising)
3 = Moderate edema (raised approx. 1 mm)
4 = Severe edema (raised more than 1 mm and extending beyond area of exposure)

Description of any dermal findings not covered by this scale were recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Slight erythema (ER) was observed in all animals during the course of the study. The cutaneous reactions were reversible in all animals within 48 hours after removal of the patch. The average score (24 to 72 hours) for irritation was calculated to be 0.1 for erythema and 0.0 for edema.

Any other information on results incl. tables

Results:

Readings Animal Erythema Edema Additional findings
1 h 1 1 0  
2 1 0  
3 1 0  
24 h 1 0 0  
2 0 0  
3 1 0  
48 h 1 0 0  
2 0 0  
3 0 0  
72 h 1 0 0  
2 0 0  
3 0 0  
mean 24 - 72 h 1 0.0 0.0  
2 0.0 0.0  
3 0.3 0.0  
mean 1 0.1 0.0  

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met