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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 September 2005 to 7 October 2005
Reliability:
2 (reliable with restrictions)
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:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tall oil
EC Number:
232-304-6
EC Name:
Tall oil
Cas Number:
8002-26-5
Molecular formula:
Variable
IUPAC Name:
Tall Oil
Test material form:
liquid: viscous
Details on test material:
- Appearance: dark, high viscous liquid
- Storage Conditions: room temperature <25 °C in the dark, may be used under light
- Stability under storage conditions: stable

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.9 to 2.1 kg
- Housing: Individually caged in metal wire cages, 79 x 59 cm bottom area, 38 cm high
- Diet (e.g. ad libitum): maintenance diet for rabbits, rich in crude fibre, ad libitum
- Water (e.g. ad libitum): Tap water, from an automatic watering system, ad libitum
- Acclimation period: 5 days for one animal; 12 days for the two remaining animals

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 19.6 °C (continuous control and recording)
- Humidity (%): Average of 64.9 % (continuous control and recording)
- Photoperiod (hrs dark / hrs light): Artificial light from 6 am to 6 pm

IN-LIFE DATES: From: 26 September 2005 To: 7 October 2005

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and served as control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Following administration, the eyes were held closed for about one second to prevent loss of the test material.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Firstly, the test material was administered to one animal. As no evidence for serious damage to the eye was found during the initial 72 hour observation period (no corrosive effect), the test material was subsequently administered to two further animals.

EYE EXAMINATIONS
Both eyes of the animals were examined within 24 hours before the instillation and approximately 1, 24, 48 and 72 hours post administration.
In addition to the eye examinations, the animals were observed for general changes at all observation times.

SCORING SYSTEM:
CORNEA
Opacity: degree of density (area most dense is taken for reading).
0 No ulceration or opacity
1 Scattered or diffuse areas of opacity (except for slight dulling of normal lustre), details of iris clearly visible
2 Easily discernible translucent area, details of iris slightly obscured
3 Nacreous area, no details of iris visible, size of pupil barely discernible
4 Opaque cornea, iris not discernible through the opacity

IRIS
0 Normal
1 Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection;
any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 No reaction to light, haemorrhage, gross destruction (any of all these or all together)

CONJUNCTIVAE
Redness: (refers to the most severe effect of palpebral and bulbar conjunctivae in comparison to the control eye)
0 Blood vessels normal
1 Some blood vessels definitely hyperaemic (injected)
2 Diffuse crimson colour, individual vessels not easily discernible
3 Diffuse beefy red
Chemosis: lids and/or nictating membranes.
0 No swelling
1 Any swelling above normal (includes nictating membranes)
2 Obvious swelling with partial eversion of lids.
3 Swelling with lids about half closed
4 Swelling with lids more than half closed

TOOL USED TO ASSESS SCORE: The entirety of each eye was examined using an otoscope lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
No effects on the cornea or iris were observed in any of the treated eyes. Some conjunctival redness and chemosis were observed at the 1 hour examination only.
The untreated eyes were normal at each observation time.
Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Table 1 Individual Scores

Time After Installation (hours)

Cornea

Iris

Conjunctival Redness

Conjunctival Chemosis

Animal Number

Animal Number

Animal Number

Animal Number

101

102

103

101

102

103

101

102

103

101

102

103

1

0

0

0

0

0

0

1*

1*

1*

0

1

1

24

0

0

0

0

0

0

0

0

0

0

0

0

48

0

0

0

0

0

0

0

0

0

0

0

0

72

0

0

0

0

0

0

0

0

0

0

0

0

Mean (24, 48 and 72 hours)

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

*Discharge with moistening of the lids and hairs just adjacent to the lids.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test material caused no irritation to the eyes of New Zealand White rabbits and therefore requires no classification in accordance with EU criteria.
Executive summary:

The irritation or corrosion effects of the test material were investigated in vivo in accordance with the standardised guidelines OECD 405 and EU Method B.5 under GLP conditions.

0.1 mL of the test material was instilled into the conjunctival sac of the right eye of 3 New Zealand White rabbits. The eyes were examined 1, 24, 48 and 72 hours post administration and the animals observed for general signs of toxicity.

The overall mean scores for corneal effects, iris effects, conjunctival redness and conjunctival chemosis were all 0.0. No symptoms of toxicity were observed in the animals.

Under the conditions of this study the test material caused no irritation to the eyes of New Zealand White rabbits and therefore requires no classification in accordance with EU criteria.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.