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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:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
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

Constituent 1
Chemical structure
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

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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