Alkenes, C15-18 α-, sulfurized

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 February 2013 to 18 February 2013

Reliability:

1 (reliable without restriction)

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:

2013

Report date:

2013

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:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alkenes, C15-18 α-, sulfurized

EC Number:

267-023-8

EC Name:

Alkenes, C15-18 α-, sulfurized

Cas Number:

67762-55-4

Molecular formula:

Not applicable, complex UVCB

IUPAC Name:

Alkenes, C15-18 α-, sulfurized

Test material form:

other: liquid (unspecified)

Details on test material:

- Appearance: dark liquid
- Stability under test conditions: stable

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana.
- Age at study initiation: Ten to twelve weeks old.
- Weight at study initiation: 3.23 to 4.0 kg.
- Housing: Animals were individually housed in stainless steel cages.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C (63 to 73 °F)
- Humidity (%): 30 to 70 %
- Photoperiod (hrs dark / hrs light): no data on light cycle; animals were housed in a light controlled room.

IN-LIFE DATES: From: 15 February 2013 To: 18 February 2013

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The contralateral eye served as the untreated control for each rabbit.

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

The animals were dosed by instilling the test material into one eye and then holding the eye lids together for one second to prevent loss of the material.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 (male)

Details on study design:

TEST MATERIAL ADMINISTRATION
One hour prior to dosing of the test material, all animals were administered Buprenorphine via subcutaneous injection at the prescribed dosage level. Additionally, five minutes before dosing, the eyes were anesthetized with Tetracaine HCL solution.

SCORING SYSTEM: The eyes were examined at 1, 24, 48 and 72 hours after treatment and scored according to the Draize scale:
CORNEA
Opacity: degree of density (area most dense is taken for reading).
0 No opacity
1 Scattered or diffuse area, details of iris clearly visible
2 Easily discernible translucent area, details of iris slightly obscured
3 Opalescent areas, no details of iris visible, size of pupil barely discernible
4 Opaque, iris invisible

IRIS
0 Normal
1 Markedly deepened rugae, congestion, swelling, moderate circumcorneal 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 or all these)

CONJUNCTIVAE
Redness: (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
0 Vessels normal
1 Vessels definitely injected above normal
2 More diffuse, deeper crimson red, individual vessels not easily discernible
3 Diffuse beefy red

Chemosis:
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: 2 % sodium fluorescein and ultraviolet light provided via a Spectroline, Model Q-12, Long Wave UV-365 nm, 10X Magnifier, were employed to reveal possible corneal injury commencing with the 24 hour observation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other:

Remarks:

not applicable

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other:

Remarks:

not applicable

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other:

Remarks:

Not applicable

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other:

Remarks:

Not applicable

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other:

Remarks:

Not applicable

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other:

Remarks:

Not applicable

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other:

Remarks:

Not applicable

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other:

Remarks:

Not applicable

Irritant / corrosive response data:

There were minimal eye irritation reactions in all of the test subjects at the 1 hour observation. All irritation subsided by the 24 hour observation. Results are summarised in Table 1.

Other effects:

Animal 35 weighed 3.23 kg at study initiation and 3.25 kg at study termination.
Animal 36 weighed 4.0 kg at study initiation and 4.14 kg at study termination.
Animal 37 weighed 3.27 kg at study initiation and 3.26 kg at study termination.

Any other information on results incl. tables

Table 1 Individual Scores

Time After Installation (hours)	Cornea			Iris			Conjunctival Redness			Chemosis
	Animal Number			Animal Number			Animal Number			Animal Number
	35	36	37	35	36	37	35	36	37	35	36	37
1	-	-	-	0	0	0	1*	0*	1*	0	0	0
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 observed (any amount different from normal; does not include small amount observed on the inner canthus of normal animals).

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 EPA OPPTS 870.2400 under GLP conditions.

0.1 mL of the test material was instilled into the 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.