RD 14153

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

the study was conducted between 20 October 2015 and 23 October 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor Lot/Batch No. PW2
- Expiration date of the lot/batch:
- Purity test date:06 Oct 2015

RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material)

OTHER SPECIFICS:

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products, Inc. Denver, PA, USA
- Age at study initiation: 28 wks
- Weight at study initiation: 2.9-3.4 kg
- Housing: Individually in suspended cages
- Diet (e.g. ad libitum): Fresh daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: > 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled but no temperature reported
- Humidity (%): controlled but no humidity reported
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: From: 20 October 2015 To: 23 October 2015

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

other: Contralateral eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 21.6 mg
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Duration of treatment / exposure:

72h

Observation period (in vivo):

72h

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
- Time after start of exposure:

SCORING SYSTEM: Draize technique

TOOL USED TO ASSESS SCORE: hand lamp - Mini-Maglite with high intensity bulb
fluorescein dye at 24h timepoint with UV light source

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1h

Score:

>= 6

Max. score:

6

Reversibility:

fully reversible

Remarks on result:

probability of weak irritation

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 1h

Score:

8

Max. score:

8

Reversibility:

fully reversible

Remarks on result:

probability of weak irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 1h

Score:

8

Max. score:

8

Reversibility:

fully reversible

Remarks on result:

probability of weak irritation

Results 4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 7

Irritation parameter:

iris score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 9

Irritation parameter:

chemosis score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

Corneal opacity and iritis were not noted at any observation period, Conjunctival irritation, noted in three out of three eyes at the 1-hour observation period, cleared by 24 hours.
Additional ocular observations of test article residue in the conjunctival sac were noted at the 1-hour observation period.
The control eyes appeared normal at all observation periods.

Other effects:

- Lesions and clinical observations:
- Ophthalmoscopic findings:
- Histopathological findings:
- Effects of rinsing or washing:
- Other observations: No physical signe were noted during the observation period.
One animal lest weight, one animal gained weight and one anim's weight remained unchanged.

Applicant's summary and conclusion

Interpretation of results:

other: Non irritant

Conclusions:

Corneal opacity and iritis were not noted at any observation period, Conjunctival irritation, noted in three out of three eyes at the 1-hour observation period, cleared by 24 hours.
Additional ocular observations of test article residue in the conjunctival sac were noted at the 1-hour observation period.
The control eyes appeared normal at all observation periods.

The substance was non irritant and is not classified according to EU and GHS classifications and is classified as Category IV under the US EPA Classification

Executive summary:

The eye irritation/corrosion effects of RD 14153 were examined in accordance with OECD 405 and US EPA OCSPP 870.2400 guidelines in three New Zealand White Rabbits over a period of 72 hours; one eye per rabbit was treated, the other acted as a control.

Corneal opacity and iritis were not noted at any observation period, Conjunctival irritation, noted in three out of three eyes at the 1-hour observation period, cleared by 24 hours. Additional ocular observations of test article residue in the conjunctival sac were noted at the 1-hour observation period. The control eyes appeared normal at all observation periods.

The substance was non irritant and is not classified according to EU and GHS classifications and is classified as Category IV under the US EPA Classification