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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18-04-2000 to 19-07-2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP. All relevant validity criteria were met.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
inspected: September 1999 ; signature: December 1999

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Physical state: Liquid
- Storage condition of test material: At room temperature, protected from light and under nitrogen gas
- Other: colourless

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: Young adult
- Weight at study initiation: 2.6 ±0.1 kg
- Housing: Individually housed in polystyrene cages (48.2 cm x 58 cm x 36.5 cm).
- Diet: certified rabbit diet ad libitum
- Water: filtered certified water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ±3
- Humidity (%): 30 - 70 (the relative humidity was stated as being periodically outside this range ; this was not considered to impact the study integrity).
- Air changes (per hr): ca. 12 cycles/hr
- Photoperiod: 12 hours light / 12 hours dark

IN-LIFE DATES: From: 18-04-2000 To: 22-04-2000

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:
A volume of 0.1 mL of the test material, was placed into the conjunctival sac of the left 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 item, and then released. The right eye remained untreated and was used for control purposes.
Observation period (in vivo):
Ocular assessment was conducted at approximately 1, 24, 48 and 72 hours after instillation of the test item, according to numerical evaluation.
Number of animals or in vitro replicates:
3 (male).
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: Not applicable.

SCORING SYSTEM:
The irritation was assessed using criteria consistent with Draize (1977) numerical scoring system. At each observation period, the highest scores given were recorded. Any other ocular effects were also noted.

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope (or if corneal opacification is difficult to determine using a UV lamp).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: mean; n=2
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: mean; n=3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: mean; n=3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: mean; n=3
Irritant / corrosive response data:
No corneal or Iridial inflammation effects were noted. Very slight conjunctival reactions (chemosis and redness, score = 1) was noted in one treated eyes 1 and 24 hours after treatment. Although chemosis fully resolved by 48 hour observation. A very slight redness (score = 1) persisted until day 4 in 1/3 treated eyes.
Other effects:
- Lesions and clinical observations: None reported.
- Ophthalmoscopic findings: None reported using fluorescein.
- Histopathological findings: None reported.
- Effects of rinsing or washing: Not applicable.
- Other observations: None reported.

Any other information on results incl. tables

Table 1. Individual scores and mean scores for 24, 48 and 72 hours

Organism number and sex

Time after treatment

Corneal Opacity

Iridial Inflammation

Conjunctival Redness

Conjunctival Chemosis

1 (male)

1h

0

1

0

1

 

24 h

0

0

0

0

 

48 h

0

0

0

0

 

72 h

0

0

0

0

 

Day 4

-

-

-

-

Mean (24 – 72 h)

 

0.00

0.00

0.00

0.00

 

 

 

 

 

 

2 (male)

1h

0

0

0

1

 

24 h

0

0

0

0

 

48 h

0

0

0

0

 

72 h

0

0

0

0

 

Day 4

-

-

-

-

Mean (24 – 72 h)

 

0.00

0.00

0.00

0.00

 

 

 

 

 

 

3 (male)

1h

0

0

1

1

 

24 h

0

0

1

1

 

48 h

0

0

1

0

 

72 h

0

0

1

0

 

Day 4

0

0

0

0

Mean (24 – 72 h)

 

0.00

0.00

1.0

0.33

 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test item is not irritating to the eye.
Executive summary:

The study was performed to OECD TG 405 and EU Method B.5 under GLP to assess the irritancy potential of the test item to the eye following a single application in the New Zealand White rabbit. A volume of 0.1 ml of the test item was placed into the conjunctival sac of one eye of three animals. The other eye remained untreated and was used for control purposes. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. A single application of the test item to the non-irrigated eye of three rabbits produced no corneal or Iridial inflammation effects. Very slight conjunctival reactions (chemosis and redness, score = 1) was noted in one treated eyes 1 and 24 hours after treatment. Although chemosis fully resolved by 48 hour observation. A very slight redness (score = 1) persisted until day 4 in 1/3 treated eyes. No other ocular reactions were reported during the study. All treated eyes appeared normal at the 4 day observation point. Under the conditions of this study, the test item is not considered to be irritating to the eye.