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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:
05.07.05 to 03.11.05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Crude Tall Oil
- Substance type: Complex mixture
- Physical state: Dark high viscous liquid
- Analytical purity: No data
- Composition of test material, percentage of components: Complex mixture
- Purity test date: No data
- Lot/batch No.: 2005-06-09, sample 4
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: Room temperature <25oC, in the dark, may be used under light.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: No data
- Weight at study initiation: 1.9-2.3 kg
- Housing: Individually in metal wire cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: between 5 and 12 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7 (average)
- Humidity (%): 71.4 (average)
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 05.09.05 To: 16.09.05

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
Four hours
Observation period:
72 hours
Number of animals:
Three females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: No data
- Type of wrap if used: patches were held in place by non-irritating tape, and covered with a semi-occlusive dressing.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with a wet cellulose tissue.
- Time after start of exposure: Four hours


SCORING SYSTEM: Comparable with OECD test guideline.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: There were no signs of irritation in any of the animals.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
ca. 0
Max. score:
0
Irritant / corrosive response data:
No signs of irritation (oedema and erythema) were observed in any of the three rabbits tested.
Other effects:
No other effects were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a good quality skin irritation study (reliability score 1) conducted to OECD test guideline 404, and GLP, Crude Tall Oil was not irritating to the skin of New Zealand White rabbits.
Executive summary:

Crude Tall Oil (0.5 ml) was applied via a patch to a site of about 2.5 cm x 2.5 cm of intact skin of each of three New Zealand white rabbits and covered by a semi-occlusive dressing for four hours. Body weights were recorded before administration and at termination of the test. General signs of toxicity were recorded daily. Skin examinations were conducted at 1, 24, 48 and 72 hours after patch removal. No signs of toxicity or death were observed. There was no erythema or oedema in any of the animals. Therefore Crude Tall Oil was not irritating to the skin.