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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:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Remarks:
Research & Consulting Company AG (CH 4452 Itingen/Switzerland)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG (CH 4414 Fuellinsdorf/Switzerland)
- Age at study initiation: 15 to 16 weeks
- Weight at study initiation: 2.6 to 2.7 kg
- Housing: Individually housed in stainless steel cages
- Diet: ad libitum pelleted standard Kliba 341, Batch 15/86 rabbit maintenance diet
- Water: Community tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40 to 70
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: Jun 6, 1986 To: Jun 13, 1986

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
Single dose administration, eyes were kept unwashed
Observation period (in vivo):
Up to 72 hours
Number of animals or in vitro replicates:
2 males and 1 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
Not rinsed.

SCORING SYSTEM: Same as the scale provided in the OECD guideline 405.

TOOL USED TO ASSESS SCORE: slit lamp and a Varta Cliptrix diagnostic 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
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Conjunctivae score of 1 after 1 hour in all three animals
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
The test article showed a primary irritation score of 0.3, when applied to the rabbit eye mucosa. In all three animals, minimal redness of the conjunctivae was observed at the 1 hour time point, but this effect was reversible within 24 hours. No corrosion of the cornea was observed at any of the measuring intervals. In the area of application, staining of the cornea and conjunctivae by pigment or coloring of the test article was observed.
Other effects:
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred. The observation was terminated 72 hours after administration of the test article. The body weight gain of all rabbits was similar. Due to the results obtained, no macroscopic organ examination was indicated.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance caused only minimal conjunctival redness revesible within 24 hours and is therefore classified as not irritating to the rabbit eye.
Executive summary:

In a GLP-compliant eye irritation study performed according to OECD guideline 405, three New Zealand White rabbits were treated with 0.1 g of the undiluted test article. The test material was placed into the conjunctival sac of the left eye of each animal; the lids were then held together for about one second in order to prevent loss of the test material. The ocular reactions were evaluated 1, 24, 48 and 72 hours after instillation and animals were checked daily for signs of systemic toxicity. The ocular reactions were graded according to the scoring scale presented in the OECD guideline 405. Under the experimental conditions employed the test article induced minimal conjunctival redness at the 1 hour time point (score of 1). All signs of irritation disappeared within 24 hours. In the area of application staining of the cornea and conjunctivae by coloring of the test article was observed. No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred. In conclusion, based on the results of this study, the test article is regarded as not irritating to the rabbit eye.