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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, using a closely related test substance.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
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, using a closely related test substance.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
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:
24/48/72 h
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.
Interpretation of results:
other: Not irritating
Remarks:
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, which has a chemical composition similar to that of Distilled Tall Oil, was not irritating to the skin of New Zealand White rabbits. It can therefore be concluded that Distilled Tall Oil is not a skin irritant.
Executive summary:

This data is being read across from the source study that tested Crude Tall Oil based on analogue read across.

 

Read-across from CTO to DTO is justified on the grounds that all the chemical constituents that are present in DTO are present in CTO i.e. fatty acids, resin acids, polymers and neutral compounds containing alcohols, hydrocarbons etc. The chemical constituent blocks of which they are comprised are compositionally very similar and are made up of constituents with common functional groups and properties. As a result the substances share very similar physicochemical properties both in terms of their bulk properties and the properties of the constituent blocks. CTO does contain some constituents that are not present in DTO and for this reason read-across from DTO to CTO is not considered appropriate. However for the purposes of read-across from CTO to DTO this is only likely to make the outcome conservative i.e. if anything the hazard of DTO is likely to be overestimated. A more detailed description of the technical justification for read-across is given in Section 1.4 of the CSR.

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.

Data source

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

Materials and methods

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

Test material

Constituent 1
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 or test system 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:
24/48/72 h
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:
24/48/72 h
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:
other: Not irritating
Remarks:
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, which has a chemical composition similar to that of Distilled Tall Oil, was not irritating to the skin of New Zealand White rabbits. It can therefore be concluded that Distilled Tall Oil is not a skin irritant.
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.