Registration Dossier

Administrative data

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.

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 405 (Acute Eye 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 / tissue source

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

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 hours
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.

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 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.