Registration Dossier
Registration Dossier
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EC number: 258-469-4 | CAS number: 53306-54-0
Skin irritation / corrosion
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:
- 2 002
- Report date:
- 2002
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- 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
- 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
Constituent 1
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
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