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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:
06 December 1991 to 09 December 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report: T-5452
- Substance type: Clear, colorless liquid
- Physical state: Liquid
- Storage condition of test material: Stored at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino Hra:(NZW)SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Inc., Kalamazoo, MI
- Age at study initiation: No data
- Weight at study initiation: 2214-2308 g
- Housing: Individually in screen-bottom cages
- Diet (e.g. ad libitum): High Fiber Rabbit Chow #5326, Purina Mills Inc.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1-22.8
- Humidity (%): 42-50
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: 06 December 1991 To: 09 December 1991

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
Duration of treatment / exposure:
Test material was instilled into the everted lower lid of the right eye, the lids were held together for 1 second. The eye remained unflushed after test material instillation.
Observation period (in vivo):
Observations for ocular irritation occured at 1, 24, 48, and 72 hours.
Number of animals or in vitro replicates:
The left eye was left untreated and served as an untreated control.
Details on study design:
SCORING SYSTEM: Primary irritation index (0-110).
TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results
Irritation parameter:
other: Primary irritation index (PII)
Basis:
mean
Time point:
other: 1 hour (HI), 72 hours (LO)
Score:
ca. 0 - ca. 5.3
Reversibility:
fully reversible
Remarks on result:
other: scale 110. Eye iritation scores can be seen in Table 1. A maximum mean PII of 5.3/110 was seen at 1 hour. The mean PII at the 72 hour observation point was 0.0/110.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
According to EU GHS classification criteria the test article does not need to be classified as an eye irritant.
Executive summary:

Acute eye irritation/corrosion potential of the test article was evaluated in rabbits following OECD guideline No. 405 “Acute Eye Irritation/Corrosion.” A single dose of 0.1 mL undiluted test material was placed in the lower lid of the right eye of 3 male New Zealand White Albino rabbits. The lower lid was gently pulled away from the eyeball for dosing and the lids were gently held together for approximately 1 second to prevent loss. The untreated left eye of each animal served as the reference control. Animals were observed for eye irritation at approximately 1, 24, 48 and 72 hours after the instillation of the test substance. At the 72 hour observation a solution of 2% fluorescein in water was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Animal F39167 had a conjunctivae redness score of 2 at the 1 and 24 hour observation points and conjunctivae chemosis score of 1 at 1 hour (chemosis completely resolved therafter). The animal’s conjunctivae redness had reduced to a score of 1 at 48 hours and completely resolved (score of 0) by 72 hours. Animal F39168 had a conjunctivae redness score of 2 at the 1 hour observation point and conjunctivae chemosis score of 1 at 1 hour (chemosis completely resolved therafter). The animal’s conjunctivae redness had reduced to a score of 1 at 24 and 48 hours and had resolved (score of 0) by 72 hours. Animal F39169 had a conjunctivae redness score of 1 at 1 hour and 24 hours and conjunctivae chemosis score of 1 at 1 hour (chemosis completely resolved therafter). The animal’s conjunctivae redness had resolved (score of 0) by 48 hours. Based on the observed scores a mean Primary Irriation Index (PII) was calculated for each observation point. At 1 hour the mean PII was 5.3/110, at 24 hours 2.7/110, at 48 hours 1.3/110, and at 72 hours 0.0/110. Based on the results of the study and according to EU GHS classification criteria the test article does not need to be classified as an eye irritant.