Registration Dossier

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:
1988-03-04 to 1988-03-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified ‘reliable without restriction’ because the study is scientifically acceptable, was conducted according to GLP standards, and was conducted according to guidelines appropriate at the time of testing.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 16 CFR 1500
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Emery 3002
- Substance type: C20 Alpha Olefin
- Physical state: Clear liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Clerco Research Farm
- Age at study initiation: Young adult
- Weight at study initiation: Not provided
- Housing: Housed individually in wire mesh cages
- Diet (e.g. ad libitum): Purina laboratory rabbit chow; ad libitum
- Water (e.g. ad libitum): Tap water; ad libitum
- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not provided
- Humidity (%): Not provided
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark


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 millilitre
- Concentration (if solution): Not specified


Duration of treatment / exposure:
72 hours
Observation period (in vivo):
24, 48, and 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing done



SCORING SYSTEM: Draize eye scoring system (Draize J. H., 1959)


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 2
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: Mean score - See individual scores.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
>= 0 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Conjunctival changes such as Grade 1 erythema were observed 24 hours post dosing in the eyes of 4/6 rabbits tested and in all rabbits 48-hours post application. By the 72-hour period, only 2 rabbits exhibited Grade 1 erythema. Conjunctival swelling (score of 1-2) was observed in 4/6 animals at the 48-hour period, but by 72 hours, the effect had lessened in severity and was seen only in 1 animal. Corrosive response data is not provided in the study report
Other effects:
No other effects reported

Any other information on results incl. tables

There was no evidence of corneal lesions or changes to the iris 72 hours post test chemical instillation. Conjunctival changes such as Grade 1 erythema were observed 24 hours after instillation in the eyes of 4/6 rabbits tested and in all rabbits 48-hours post application. By the 72-hour period, only 2 rabbits exhibited Grade 1 erythema. Conjunctival swelling (score of 1-2) was observed in 4/6 animals at the 48-hour period, but by 72 hours, the effect had lessened in severity and was seen only in one animal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Based on the study outcome, Emery 3002 is not considered an ocular irritant.
Executive summary:

In a primary eye irritation study, 6 female New Zealand White rabbits were instilled with 0.1 mL of Emery 3002 in the right eye. The left eye served as control. Treated eyes were not rinsed or washed. Following test chemical instillation, the animals were observed for any gross signs of eye irritation at 24, 48 and 72 hours. Scoring of irritative effects was performed using the Draize eye scoring method (1959).

 

There was no evidence of corneal lesions or changes to the iris 72 hours post test chemical instillation. Conjunctival changes such as Grade 1 erythema were observed 24 hours after instillation in the eyes of 4/6 rabbits tested and in all rabbits 48-hours post application. By the 72-hour period, only 2 rabbits exhibited Grade 1 erythema. Conjunctival swelling (score of 1-2) was observed in 4/6 animals at the 48-hour period, but by 72 hours, the effect had lessened in severity and was seen only in one animal. Based on this study outcome, Emery 3002 is not considered an ocular irritant.

 

This study received a Klimisch score of 1 and is classified as “reliable without restriction” because the study is scientifically acceptable, was conducted according to GLP standards, and was conducted according to guidelines appropriate at the time of testing.

 

This study will influence the DNEL(s).