Tall oil, potassium salt

Eye irritation

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Crude Tall oil

Molecular formula:

Not applicab;le as it is a UVCB.

IUPAC Name:

Crude Tall oil

Test material form:

liquid

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

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:

GHS criteria not met

Conclusions:

Under the conditions of this study the test substance was not irritating to rabbit eyes.

Executive summary:

The eye irritation potential of the test substance was investigated in vivo according to OECD Guideline 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 substance was not irritating to rabbit eyes (Wolf, 2005).