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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Remarks:
This study was conducted according to guideline in effect at time of study conduct.
Qualifier:
according to
Guideline:
other: U.S. EPA Health Effects Test Guidelines OPPTS 870.2400
Deviations:
no
Remarks:
This study was conducted according to guideline in effect at time of study conduct.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: 97.59%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 2366, 2518, 2512 g
- Housing: Singly in suspended stainless steel, wire-mesh cages. Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326; daily amount not reported
- Water (e.g. ad libitum): filtered tap water supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 14 or 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21ºC
- Humidity (%): 51-65%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye of each rabbit was not treated with the test substance and served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
1, 24, 48, and 72 hours after treatment.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treated and control eyes of all rabbits remained unwashed.

SCORING SYSTEM: Draize Scale

TOOL USED TO ASSESS SCORE: Illumination and fluorescein stain (24-hour evaluation).

The study was conducted in a stepwise fashion. Initially, one-tenth of a millilitre of the test substance was instilled into the conjunctival sac of the right eye of one rabbit. The left eye remained untreated and served as a control. Ocular irritation was evaluated by the method of Draize et al. Since irritation cleared by 48 hours and there was no significant irritation observed in this animal, the test was completed on two additional animals.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
other: range
Time point:
other: 1 - 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
other: range
Time point:
other: 1 - 72 hours
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
other: range
Time point:
other: 1 - 72 hours
Score:
0 - 2
Max. score:
4
Reversibility:
fully reversible within: 72 hours (redness)
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
other: range
Time point:
other: 1 - 72 hours
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 24 hours (chemosis)
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
other: range
Time point:
other: 1 - 72 hours
Score:
0 - 2
Max. score:
4
Reversibility:
fully reversible within: 48 hours (discharge)
Irritant / corrosive response data:
One hour after test substance instillation, all three treated eyes exhibited conjunctivitis. The overall incidence and severity of irritation decreased with time. All animals were free of ocular irritation within 72 hours. The ocular scores from individual animals with respect to observation time are presented in Table 1.
Other effects:
One animal exhibited soft faeces and ano-genital staining on Days 1 through 4. Body weight loss of 11% of initial weight occurred in this rabbit by study termination. The other two rabbits appeared active and healthy and experienced body weight gain during the study.

Any other information on results incl. tables

 

Table 1

Individual Rabbit Ocular Irritation Scores Following Treatment with Test Substance

Rabbit

Number

Cornea

Iritis

Conjunctiva

Opacity

Area

Redness

Chemosis

Discharge

1 Hour

3401

3402

3403

0

0

0

4

4

4

0

0

0

2

2

2

1

1

1

2

1

2

24 Hours

3401

3402

3403

0

0

0

4

4

4

0

0

0

1

1

1

0

0

0

0

1

1

48 Hours

3401

3402

3403

0

0

0

4

4

4

0

0

0

0

1

1

0

0

0

0

0

0

72 Hours

3401

3402

3403

0

0

0

4

4

4

0

0

0

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: Directive 67/548/EEC; Globally Harmonized System (GHS)
Conclusions:
One hour after test substance instillation, all three treated eyes exhibited conjunctivitis. The overall incidence and severity of irritation decreased with time. All animals were free of ocular irritation within 72 hours.

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
Executive summary:

A primary eye irritation test was conducted with rabbits to determine the potential for the test substance to produce irritation from a single instillation via the ocular route. The study was conducted in a stepwise fashion. Initially, one-tenth of a millilitre of the test substance was instilled into the conjunctival sac of the right eye of one rabbit. The left eye remained untreated and served as a control. Ocular irritation was evaluated by the method of Draize et al. Since irritation cleared by 48 hours and there was no significant irritation observed in this animal, the test was completed on two additional animals. One hour after test substance instillation, all three treated eyes exhibited conjunctivitis. The overall incidence and severity of irritation decreased with time. All animals were free of ocular irritation within 72 hours.