TOMILAC 214

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 March to 10 April 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Recently conducted GLP compliant study using the most recent test methods

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

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

Details on test material:

- Name of test material (as cited in study report): JKY-214
- Physical state: white solid
- Analytical purity: No information
- Lot/batch No.: Y002E
- Expiration date of the lot/batch: No information
- Stability under test conditions: No information. Assumed stable due to no data to the contrary
- Storage condition of test material: room temperature in the dark
- Other:

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan France SARL
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.9 to 4.24 kg
- Housing: individually housed in suspended cages
- Diet (e.g. ad libitum): Free access to food (Certified Rabbit Diet)
- Water (e.g. ad libitum): Free access to mains drinking water
- Acclimation period: at least five days each animal


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: not reported

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml of the test material (approx 77mg)
- Concentration (if solution): n/a

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

1 hour and 24, 48 and 72 hours following treatment

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure: n/a


SCORING SYSTEM: Kay and Callandra; Kay J H and Calandra J C (1962), J. Soc. Cosmet. Chem. 13, 281-289


TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope

Results and discussion

In vivo

Results

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 and 48 hr

Score:

8

Max. score:

8

Reversibility:

fully reversible within: 48 hrs

Irritant / corrosive response data:

No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in both treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24-hour observation.
Both treated eyes appeared normal at the 48-hour observation.

Other effects:

All animals showed expected gain in bodyweight during the study

Any other information on results incl. tables

Individual Scores and Individual Total Scores for Ocular Irritation

Rabbit Number and Sex	68319 Male				68331 Male
	IPR = 2				IPR = 2
Time After Treatment	1 Hour	24 Hours	48 Hours	72 Hours	1 Hour	24 Hours	48 Hours	72 Hours
CORNEA
E = Degree of Opacity	0	0	0	0	0	0	0	0
F = Area of Cornea Involved	0	0	0	0	0	0	0	0
Score (E x F) x 5	0	0	0	0	0	0	0	0
IRIS
D	0	0	0	0	0	0	0	0
Score (D x 5)	0	0	0	0	0	0	0	0
CONJUNCTIVAE
A = Redness	2	1	0	0	2	1	0	0
B = Chemosis	1	0	0	0	1	0	0	0
C = Discharge	1	0	0	0	1	0	0	0
Score (A + B + C) x 2	8	2	0	0	8	2	0	0
Total Score	8	2	0	0	8	2	0	0

IPR = Initial Pain Reaction Individual Total Scores and Group Mean Scores for Ocular Irritation

Rabbit Number and Sex	Individual Total Scores At:
	1 Hour	24 Hours	48 Hours	72 Hours
68319 Male	8	2	0	0
68331 Male	8	2	0	0
Group Total	16	4	0	0
Group Mean Score	8.0	2.0	0.0	0.0

Individual Bodyweights and Bodyweight Changes

Rabbit Number and Sex	Individual Bodyweight (kg)		Bodyweight Change (kg)
	Day 0	Day 3
68319 Male	4.24	4.40	0.16
68331 Male	2.90	3.01	0.11

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material produced a maximum group mean score of 8.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The substance is classified as NON-IRRITANT. No corrosive effects were noted.

Executive summary:

The acute eye irritation has been assessed by means of exposure to rabbits according to EU method B5 in compliance with GLP. As no corrosivity or irritation were observed during the study, the substance is considered not irritating.