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EC number: 202-374-2 | CAS number: 94-91-7
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- α,α'-propylenedinitrilodi-o-cresol
- EC Number:
- 202-374-2
- EC Name:
- α,α'-propylenedinitrilodi-o-cresol
- Cas Number:
- 94-91-7
- Molecular formula:
- C17H18N2O2
- IUPAC Name:
- α,α'-propylenedinitrilodi-o-cresol
- Details on test material:
- - Name of test material (as cited in study report): alpha,alpha'-Propylenedinitrilodi-o-cresol
- Physical state: Solid melt to liquid / highly viscous/ yellowish
- Analytical purity: > 99% (determined by Capillary GC)
- Lot/batch No.: 11000129U0
- Expiration date of the lot/batch: February 04, 2013
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: 6-8 months
- Weight at study initiation: 3.94-4.79 kg
- Housing: single housing
- Diet (e.g. ad libitum): STANRAB (P) SQC
- Water. Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30-70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test patch (2.5 cm x 2.5 cm) was moistened with a dose of 0.5 mL of the undiluted liquid test item.
The test item was molten at 80 °C for approx. 1 hour and was administrated hand warm. - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 72 hrs
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of the exposure period with Lutrol®** and Lutrol® / water (1 : 1).
- Time after start of exposure: 4 hrs
SCORING SYSTEM:
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)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.53
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- In all animals very slight erythema (grade 1) was noticed immediately after removal of the patch and persisted in two of these animals up to hour 24. In the third animal very slight erythema was also noted at hour 1 but increased to well-defined erythema (grade 2) at the 24-hours reading. At hour 48 very slight erythema was observed in this animal. The cutaneous reactions were reversible in all animals within 72 hours after removal of the patch.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Considering the described cutaneous reactions as well as the average score for irritation, alpha,alpha'-Propylenedinitrilodi-o-cresol does not show a skin irritating potential under the test conditions chosen.
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