Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1998 to November 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
According to OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN, USA.
- Age at study initiation: Adult
- Weight at study initiation: not reported
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21  deg. C
- Humidity (%): 19-50%,
- Air changes (per hr): 10-15 per hour
- Photoperiod: 12-h light/12-h dark photoperiod.

IN-LIFE DATES: not reported

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 g

VEHICLE: none reported
Duration of treatment / exposure:
168 hour(s)
Observation period (in vivo):
up to 7 days
Number of animals or in vitro replicates:
3
Details on study design:
Both eyes of each test animal were examined prior to testing to identify any pre-existing ocular irritation or corneal injury.  Three rabbits (one  
male and two females) were dosed with 0.1 g of the test substance and the eyes were not rinsed.  The test article was instilled into the conjunctival 
sac of the right eye of each animal, a minimum of 1 hour after preliminary examination.  Following instillation, the eyelids were gently held together 
for one second to limit test article loss.  The  untreated left eye of each animal served as the control.  Animals were examined twice daily.  Body weights were  measured prior to dosing.  All animals were sacrificed at the end of the  study duration.  No necropsy examinations were performed.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): using physiological saline
- Time after start of exposure: 24 hours

SCORING SYSTEM: Ocular observations were conducted at 1, 24, 48 and 72 hours and up to 7  days after dosing.  Eyes were scored using the EEC Ocular Evaluation Criteria, which is based on Draize (1959).

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
cornea opacity score
Basis:
animal: 52401
Remarks:
male
Time point:
other: 1 hr
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
cornea opacity score
Basis:
animal: 52401
Remarks:
male
Time point:
24 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
cornea opacity score
Basis:
animal: 52401
Remarks:
male
Time point:
48 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
cornea opacity score
Basis:
animal: 52401
Remarks:
male
Time point:
72 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
cornea opacity score
Basis:
animal: 52627
Remarks:
female
Time point:
other: 1 hr
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
cornea opacity score
Basis:
animal: 52627
Remarks:
female
Time point:
24 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
cornea opacity score
Basis:
animal: 52627
Remarks:
female
Time point:
48 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
cornea opacity score
Basis:
animal: 52627
Remarks:
female
Time point:
72 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
cornea opacity score
Basis:
animal: 52525
Remarks:
female
Time point:
other: 1 hr
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
cornea opacity score
Basis:
animal: 52525
Remarks:
female
Time point:
24 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
cornea opacity score
Basis:
animal: 52525
Remarks:
female
Time point:
48 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
cornea opacity score
Basis:
animal: 52525
Remarks:
female
Time point:
72 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
cornea opacity score
Basis:
animal: 52525
Remarks:
female
Time point:
7 d
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hours
Score:
0.33
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
iris score
Basis:
animal: 52401
Remarks:
male
Time point:
other: 1 hr
Score:
1
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
iris score
Basis:
animal: 52401
Remarks:
male
Time point:
24 h
Score:
1
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
iris score
Basis:
animal: 52401
Remarks:
male
Time point:
48 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
iris score
Basis:
animal: 52401
Remarks:
male
Time point:
72 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
iris score
Basis:
animal: 52627
Remarks:
female
Time point:
other: 1 hr
Score:
1
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
iris score
Basis:
animal: 52627
Remarks:
female
Time point:
24 h
Score:
1
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
iris score
Basis:
animal: 52627
Remarks:
female
Time point:
48 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
iris score
Basis:
animal: 52627
Remarks:
female
Time point:
72 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
iris score
Basis:
animal: 52525
Remarks:
female
Time point:
other: 1 hr
Score:
1
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
iris score
Basis:
animal: 52525
Remarks:
female
Time point:
24 h
Score:
1
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
iris score
Basis:
animal: 52525
Remarks:
female
Time point:
48 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
iris score
Basis:
animal: 52525
Remarks:
female
Time point:
72 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
iris score
Basis:
animal: 52525
Remarks:
female
Time point:
7 d
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 48 hours
Score:
0.67
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 52401
Remarks:
male
Time point:
other: 1 hr
Score:
1
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 52401
Remarks:
male
Time point:
24 h
Score:
1
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 52401
Remarks:
male
Time point:
48 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 52401
Remarks:
male
Time point:
72 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 52627
Remarks:
female
Time point:
other: 1 hr
Score:
1
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 52627
Remarks:
female
Time point:
24 h
Score:
1
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 52627
Remarks:
female
Time point:
48 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 52627
Remarks:
female
Time point:
72 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 52525
Remarks:
female
Time point:
other: 1 hr
Score:
2
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 52525
Remarks:
female
Time point:
24 h
Score:
2
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 52525
Remarks:
female
Time point:
48 h
Score:
1
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 52525
Remarks:
female
Time point:
72 h
Score:
1
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 52525
Remarks:
female
Time point:
7 d
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
chemosis score
Remarks:
edema
Basis:
mean
Time point:
other: 48 hours
Score:
0.44
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
chemosis score
Remarks:
edema
Basis:
animal: 52401
Remarks:
male
Time point:
other: 1 hr
Score:
2
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
chemosis score
Remarks:
edema
Basis:
animal: 52401
Remarks:
male
Time point:
24 h
Score:
1
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
chemosis score
Remarks:
edema
Basis:
animal: 52401
Remarks:
male
Time point:
48 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
chemosis score
Remarks:
edema
Basis:
animal: 52401
Remarks:
male
Time point:
72 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
chemosis score
Remarks:
edema
Basis:
animal: 52627
Remarks:
female
Time point:
other: 1 hr
Score:
2
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
chemosis score
Remarks:
edema
Basis:
animal: 52627
Remarks:
female
Time point:
24 h
Score:
1
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
chemosis score
Remarks:
edema
Basis:
animal: 52627
Remarks:
female
Time point:
48 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
chemosis score
Remarks:
edema
Basis:
animal: 52627
Remarks:
female
Time point:
72 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
chemosis score
Remarks:
edema
Basis:
animal: 52525
Remarks:
female
Time point:
other: 1 hr
Score:
2
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
chemosis score
Remarks:
edema
Basis:
animal: 52525
Remarks:
female
Time point:
24 h
Score:
2
Reversibility:
fully reversible
Remarks on result:
other: non irritant
Irritation parameter:
chemosis score
Remarks:
edema
Basis:
animal: 52525
Remarks:
female
Time point:
48 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
chemosis score
Remarks:
edema
Basis:
animal: 52525
Remarks:
female
Time point:
72 h
Score:
0
Remarks on result:
other: non irritant
Irritation parameter:
chemosis score
Remarks:
edema
Basis:
animal: 52525
Remarks:
female
Time point:
7 d
Score:
0
Remarks on result:
other: non irritant
Irritant / corrosive response data:
Exposure to the test article produced irrititis in 3/3 test eyes at the 1-hour scoring interval.  
The irititis resolved completely by 48 hours.   Conjunctivitis was noted in 3/3 test eyes at the 1-hour scoring interval.   
Conjunctival irritation resolved completely in all test eyes by study day  7.  
Based on the results of the test, the test substance is considered a mild irritant to the ocular tissue of the rabbit.
Other effects:
No other effects were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Classification: not irritating
Executive summary:

STUDY RATED BY AN INDEPENDENT REVIEWER.

ROBUST SUMMARY DEVELOPED BY AN INDEPENDENT REVIEWER.

Robust Summary for SLI (1999):

Adult New Zealand rabbits were obtained from Myrtle's Rabbitry, Thompson Station, TN, USA.  Animals were individually housed and provided food and  

water ad libitum.  Room temperature and humidity were maintained at 19-21 deg. C and 19-50%, respectively.  Light exposure was maintained as a 12-h  

light/12-h dark photoperiod.

Both eyes of each test animal were examined prior to testing to identify any pre-existing ocular irritation or corneal injury.  Three rabbits (one  

male and two females) were dosed with 0.1 g of the test substance and the eyes were not rinsed.  The test article was instilled into the  conjunctival 

sac of the right eye of each animal, a minimum of 1 hour  after preliminary examination.  Following instillation, the eyelids were  gently held together 

for one second to limit test article loss.  The  untreated left eye of each animal served as the control.

Ocular observations were conducted at 1, 24, 48 and 72 hours and up to 7 days after dosing.  Animals were examined twice daily.  Body weights were 

 measured prior to dosing.  All animals were sacrificed at the end of the study duration.  No necropsy examinations were performed.

Eyes were scored using the EEC Ocular Evaluation Criteria, which is based on Draize (1959).

Exposure to the test article produced irrititis in 3/3 test eyes at the 1-hour scoring interval.  The irititis resolved completely by 48 hours.   

Conjunctivitis was noted in 3/3 test eyes at the 1-hour scoring interval. Conjuntival irritation resolved completely in all test eyes by study day  7.  

No other effects were observed.

Based on the results of the test, the test substance is considered a mild irritant to the ocular tissue of the rabbit.