Registration Dossier

Administrative data

Description of key information

No reliable irritation/corrosion data are available for Distilled Tall Oil, therefore good quality guideline studies for the related substance Crude Tall Oil are read

across.


Crude Tall Oil was found to be not irritating to rabbit skin and eyes in reliable studies conducted according to the appropriate OECD test guidelines and in compliance with GLP (ARC, 2005c-e).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
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
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.
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:

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26.09.05 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.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues 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): 19.6 (average)
- Humidity (%): 64.9 (average)
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 26.09.05 To: 07.10.05
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml


Duration of treatment / exposure:
Until eyes naturally washed away test substance.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing


SCORING SYSTEM: Comparable to OECD test guideline.


TOOL USED TO ASSESS SCORE: the whole eyes, cornea, iris and conjunctivae were examined with an otoscope.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritant / corrosive response data:
One hour post-instillation all animals had grade 1 conjunctival redness, and 2/3 animals had grade 1 conjunctival chemosis. Ocular discharge was noted in all animals one hour after instillation. There were no signs of irritation at any other time point. There were no effects on the cornea and iris.
Other effects:
No signs of systemic toxicity were observed.
Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
In a good quality eye irritation study (reliability score 1) conducted according to OECD test guideline 405, and GLP, Crude Tall Oil was not irritating to the eyes of New Zealand white rabbits.
Executive summary:

Crude Tall Oil (0.1 ml) was instilled into the conjunctival sac of the right eye of each of three New Zealand white rabbits. The eyes were held closed for one second to prevent loss of the test substance. The untreated left eyes served as the controls. Both eyes were examined within 24 hours before the instillation, and approximately 1, 24, 48 and 72 hours post-instillation. There were no deaths or signs of toxicity in any of the animals. The untreated eyes were normal at each observation. One hour post-instillation all animals had grade 1 conjunctival redness, and 2/3 animals had grade 1 conjunctival chemosis. Ocular discharge was noted in all animals one hour after instillation. There were no signs of irritation at any other time point. There were no effects on the cornea and iris. Crude Tall Oil was concluded not to be irritating to the eyes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A skin irritation study is available for Distilled Tall Oil. The study was carried out in accordance with OECD Test Guideline 404 and in compliance with GLP, but only one animal was tested. No skin reactions were observed up to and including the 72 hour observation. Reliable in vitro skin corrosion and in vivo skin irritation studies are, however, available for the related substance Crude Tall Oil. Crude Tall Oil was shown not to be corrosive in vitro or to be irritating to rabbit skin in vivo.

No eye irritation study is available for Distilled Tall Oil. However a reliable study, carried out in accordance with OECD Test Guideline 405 and in compliance with GLP, is available for the related substance Crude Tall Oil. Minor effects were observed at the 1 hour observation, but at no other time point.

Read-across of irritation test data 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.

Justification for classification or non-classification

According to the criteria set out in Regulation 1272/2008, Distilled Tall Oil is not classified for skin or eye irritation based on studies carried out using either Distilled Tall Oil or the related substance Crude Tall Oil.

In a skin irritation test with Distilled Tall Oil, no skin reactions were observed in one animal. In a test with Crude Tall Oil, no erythema or oedema was observed in three animals.

In an eye irritation test with Crude Tall Oil, minimal effects were observed which were fully resolved by the 24 hour examination.