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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:
26th November 2001 to 30th November 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Hydrocarbon waxes (petroleum), oxidized
EC Number:
265-205-1
EC Name:
Hydrocarbon waxes (petroleum), oxidized
Cas Number:
64743-00-6
Molecular formula:
too complex
IUPAC Name:
Hydrocarbon waxes (petroleum), oxidized
Test material form:
other: greasy solid
Details on test material:
- Physical appearance: Light Brown semi-solid.
- Storage: Room temperature and humidity.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harvey's Lake, PA.
- Date received: 31/10/01.
- Age at study initiation: Animals were born on 04/09/01.
- Weight at study initiation: 2.5-2.8 kg.
- Housing: Individually in suspended wire cages.
- Diet (e.g. ad libitum): Fresh Purina Rabbit Chow, Diet # 5321, supplied by Purina Mills, Inc. Food provided daily.
- Water (e.g. ad libitum): ad libitum.
- Quarantine period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled.
- Photoperiod (hrs dark / hrs light): 12 hrs light/dark cycle.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml/rabbit.
Duration of treatment / exposure:
- 4 hours.
Observation period:
- Up to 72 hours.
Number of animals:
- Three in total, two females and one male.
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm.
- Type of wrap if used: The torso was wrapped with plastic.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with distilled water.
- Time after start of exposure: Immediately after patch removal.

OBSERVATIONS
- Time points: 60 minutes, 24, 48 and 72 hours.
- Dermal reaction, ulceration, necrosis or any evidence of tissues destruction were recorded at each time point.
- General health was recorded at each time point.
- Body weights were recorded before exposure and at termination.

SCORING SYSTEM: Erythema and edema were scored according to the Draize scale (1977), which can be seen in table 1.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Av. of 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Av. of 24, 48 and 72 hour
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Other effects:
- No abnormal physical signs were noted during the observation period.
- One animal lost body weight, all other weight changes were normal.

Any other information on results incl. tables

Table 2. Results of Observed Dermal Reactions

Observation Animal and Sex Time after patch removal Average Score of 24, 48 and 72 hrs.
60 (mins) 24 (hrs) 48 (hrs) 72 (hrs)
Erythema Score Female No. 1 2 1 0 0 0.33
Female No. 2 1 1 0 0
Male No. 3 1 1 0 0
Edema Score Female No. 1 0 0 0 0 0.11
Female No. 2 0 0 0 0
Male No. 3 1 1 0 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The study concludes that the test material is a dermal irritant. However under the conditions of the test to severity of the dermal reaction observed was not enough to justify a classification according to Regulation (EC) 1272/2008. Therefore the results have been interpreted as "not classified".
Executive summary:

In a GLP compliant, dermal irritation, study performed according to the standardised guideline EPA OPPTS 870.2500, three rabbits were exposed to the test material for a period of 4 hours. The average dermal reaction, taken from 24, 48 and 72 hours, was scored according to the Draize (1977) scale as follows: erythema 0.33 and edema 0.11, all observed signs of irritation completely reversed within 48 hours. Under the conditions of the test, the observed dermal reaction was not severe enough to justify a classification according to Regulation (EC) 1272/2008.

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