Condensation products of oil shale alkylresorcinols and formaldehyde

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 April 2004 - 16 April 2004.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted 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:

2004

Report date:

2004

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 (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

447-830-3

EC Name:

-

Molecular formula:

Not applicable to this UVCB substance.

IUPAC Name:

2-ethylphenol; 3,5-dimethylphenol; formaldehyde; phenol

Test material form:

other: solid resin

Details on test material:

- Date received: 30 January 2004
- Storage conditions: room temperature in the dark, under nitrogen

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 - 20 weeks old
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): free access to certified rabit diet
- Water (e.g. ad libitum): free access to mains drinking water
- Acclimation period: at least five days
- Other: The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

IN-LIFE DATES: From: 07 April 2004 To: 16 April 2004.

Test system

Vehicle:

water

Remarks:

Distilled

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL (approx. 72 mg)

Duration of treatment / exposure:

The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test material, and then released.

Observation period (in vivo):

Observations were made 1, 24, 48 and 72 hours after treatment.

Number of animals or in vitro replicates:

3

Details on study design:

ADIMINSTRATION OF TEST SUBSTANCE
Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.
Initially, a single rabbit was treated. A volume of 0.1 mL of the test material, which was found to weigh approximately 72 mg (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain reaction was made.
After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.

SCORING SYSTEM: Draize JH (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49). See Table 1.
Immediately after administration of the test material, an assessment of the initial pain reaction was made according to the six point scale shown in Table 2.

TOOL USED TO ASSESS SCORE: standard ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean of 24, 48 and 72 h time points

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean of 24, 48 and 72 h time points

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean of 24, 48 and 72 h time points

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean of 24, 48 and 72 h time points

Score:

0

Max. score:

4

Reversibility:

other: no chemosis observed

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: mean of 24, 48 and 72 h time points

Score:

0

Max. score:

4

Reversibility:

other: no chemosis observed

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: no chemosis observed

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: mean of 24, 48 and 72 h time points

Score:

0

Max. score:

4

Reversibility:

other: no effect on the cornea observed

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: mean of 24, 48 and 72 h time points

Score:

0

Max. score:

4

Reversibility:

other: no effect on the cornea observed

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: mean of 24, 48 and 72 h time points

Score:

0

Max. score:

3

Reversibility:

other: no effect on the cornea observed

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: mean of 24, 48 and 72 h time points

Score:

0

Max. score:

2

Reversibility:

other: not effect on the iris observed

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: mean of 24, 48 and 72 h time points

Score:

0

Max. score:

2

Reversibility:

other: no effect on the iris observed

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: mean of 24, 48 and 72 h time points

Score:

0

Max. score:

2

Reversibility:

other: no effect on the iris observed

Irritant / corrosive response data:

No corneal or iridial effects were noted during the study. Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation in all treated eyes at the 24-hour observation. All treated eyes appeared normal at the 48-hour observation.

Other effects:

None

Any other information on results incl. tables

Table 3: Individual Scores and Individual Total Scores for Ocular Irritation

Rabbit Number	Rabbit #1				Rabbit #2				Rabbit #3
	IPR = 2				IPR = 2				IPR = 2
Time After Treatment (hours)	1	24	72	72	1	24	72	72	1	24	72	72
CORNEA
E = Degree of Opacity	0	0	0	0	0	0	0	0	0	0	0	0
F = Area of Cornea Involved	0	0	0	0	0	0	0	0	0	0	0	0
Score (E x F) x 5	0	0	0	0	0	0	0	0	0	0	0	0
IRIS
D	0	0	0	0	0	0	0	0	0	0	0	0
Score (D x 5)	0	0	0	0	0	0	0	0	0	0	0	0
CONJUNCTIVAE
A = Redness	2	1	0	0	1	1	0	0	1	1	0	0
B = Chemosis	1	0	0	0	1	0	0	0	1	0	0	0
C = Discharge	1	0	0	0	1	0	0	0	1	0	0	0
Score (A + B + C) x 2	8	2	0	0	6	2	0	0	6	2	0	0
Total Score	8	2	0	0	6	2	0	0	6	2	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material is not considered to be irritating to the eyes of rabbits.

Executive summary:

The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. Three rabbits were used. 0.1 mL of the test material was placed into the conjunctival sac of the right eye. The left eye served as the control. The irritation was scored according to the method of Draize (1977). The study was conducted in accordance with the OECD 405 and EU Method B.5 guidelines and to GLP standard in a certified laboratory.

Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation in all treated eyes at the 24-hour observation. All treated eyes appeared normal at the 48-hour observation.

The test material is therefore not considered to be irritating to the eyes of rabbits.