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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:
28 November 1997 - 09 January 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
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): CN386- Physical state: Clear colorless liquid- Lot/batch No.: CK664- Storage condition of test material: At room temperature and humidity

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: Ace Animals, Boyertown, PA, USA- Weight at study initiation: 2.1 - 2.3 kg- Housing: Individually in suspended metal cages- Diet (e.g. ad libitum): Purina Rabbit Chow (Diet no. 5321)- Acclimation period: At least 5 daysENVIRONMENTAL CONDITIONS- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye remained untreated.
Amount / concentration applied:
A 0.1 ml amount of the test substance was placed into the conjunctival sac of the lower everted lid of one eye of each animal.
Duration of treatment / exposure:
The eyelids were then gently held together for one second before releasing.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): NoneSCORING SYSTEM: Draize scaleTOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 h
Score:
36
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 h
Score:
41
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48 h
Score:
36
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 72 h
Score:
22
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 7 d
Score:
0
Irritant / corrosive response data:
Corneal opacity and conjunctival irritation, noted in 3/3 eyes, cleared by Day 7. Iritis, noted in 3/3 eyes, cleared by Day 3.
Other effects:
One instance of diarrhea was the only abnormal physical sign noted during the observation period.

Any other information on results incl. tables

Table 1: Ocular findings and systemic observations    
Animal no. Item Tissue Reading 1 h 24 h 48 h 72 h 7 d
1 A Cornea Opacity 2 2 2 2 0
B   Area 2 2 2 1 0
  1. Total = (AxB)x5   20 20 20 10 0
C Iris   0 1 1 0 0
  2. Total = Cx5   0 5 5 0 0
D Conjunctiva Redness 2 2 2 1 0
E   Chemosis 3 3 2 2 0
F   Discharge 2 2 2 2 0
3. Total = (D+E+F)x2   14 14 12 10 0
Total = 1+2+3   34 39 37 20 0
Systemic observations   A A A A A
Pretest bodyweight 2.2 kg          
Animal no. Item Tissue Reading 1 h 24 h 48 h 72 h 7 d
2 A Cornea Opacity 2 2 2 2 0
B   Area 2 2 2 1 0
  1. Total = (AxB)x5   20 20 20 10 0
C Iris   1 1 0 0 0
  2. Total = Cx5   5 5 0 0 0
D Conjunctiva Redness 2 2 1 1 0
E   Chemosis 2 2 2 2 0
F   Discharge 2 2 2 0 0
  3. Total = (D+E+F)x2   12 12 10 6 0
Total = 1+2+3   37 37 30 16 0
Systemic observations   A A A D A
Pretest bodyweight 2.3 kg          
Animal no. Item Tissue Reading 1 h 24 h 48 h 72 h 7 d
3 A Cornea Opacity 2 2 2 2 0
B   Area 2 3 3 2 0
  1. Total = (AxB)x5   20 30 30 20 0
C Iris   1 1 0 0 0
  2. Total = Cx5   5 5 0 0 0
D Conjunctiva Redness 2 2 1 1 0
E   Chemosis 2 2 2 2 0
F   Discharge 2 2 2 2 0
3. Total = (D+E+F)x2   12 12 10 10 0
Total = 1+2+3   37 47 40 30 0
Systemic observations   A A A A A
Pretest bodyweight 2.1 kg          
Mean scores   36 41 36 22 0
A: normal; D: diarrhea

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

A study was performed to assess the eye irritancy potential of the test substance in New Zealand White rabbits according to OECD Guideline 405.

A single ocular dose of 0.1 mL of test substance was applied into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. Examination of the eyes was made 1, 24, 48 and 72 hours post dose, then on Day 7. SCoring was conducted according to the method of Draize. The general health of the animals was monitored at each observation time. Bodyweights were recorded pretest.

Corneal opacity and conjunctival irritation, noted in 3/3 eyes, cleared by Day 7. Iritis, noted in 3/3 eyes, cleared by Day 3. One instance of diarrhea was the only abnormal physical sign noted during the observation period.

Under the test conditions, the test substance was considered to be irritating but not corrosive to eyes.