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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:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: reversibiltiy of effects have not been tested

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
: reversibility after 21 days was not examined, no individual animal data
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Lupersol 223 (Di(2-Ethylhexyl)Peroxydicarbonate)
- Substance type: organic peroxide; clear liquid
- Physical state: liquid
- Lot/batch No.: OMGQ 281

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 1858 to 2447 g
- Housing: individually
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): maintained throughout study
- Humidity (%): maintained throughout study
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted
Duration of treatment / exposure:
Instilled into the conjunctival sac of the right eye in each rabbit. Exposure throughout the observation period.
Observation period (in vivo):
Observation after 24 h, 48 h and 72 h
Number of animals or in vitro replicates:
6 (3 males and 3 females)
Details on study design:
SCORING SYSTEM: Scale for scoring ocular lesions (Draize, J.H., 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: 24 h
Score:
0
Max. score:
0
Remarks on result:
other: no data of individual animals
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Remarks on result:
other: no data of individual animals
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
14.6
Reversibility:
not specified
Remarks on result:
other: no data of individual animals
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48
Score:
0
Remarks on result:
other: no data of individual animals
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 h
Score:
0
Remarks on result:
other: no data of individual animals
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48
Score:
13.6
Reversibility:
not specified
Remarks on result:
other: no data of individual animals
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 h
Score:
0
Remarks on result:
other: no data of individual animals
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 h
Score:
0
Remarks on result:
other: no data of individual animals
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
13
Reversibility:
not specified
Remarks on result:
other: no data of individual animals
Irritation parameter:
other: Conjunctivae Redness
Basis:
mean
Time point:
other: 24
Score:
>= 2 - <= 2.5
Max. score:
2.5
Reversibility:
not specified
Remarks on result:
other: no data of individual animals
Irritation parameter:
other: Conjunctivae Redness
Basis:
mean
Time point:
other: 48
Score:
>= 1 - <= 2.5
Max. score:
2.5
Reversibility:
not specified
Remarks on result:
other: no data of individual animals
Irritation parameter:
other: Conjunctivae Redness
Time point:
other: 72 h
Score:
>= 1 - <= 3
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: no data of individual animals
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
>= 3 - <= 4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no data on individual animals
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 h
Score:
>= 3 - <= 4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no data on individual animals
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 h
Score:
>= 3 - <= 4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no data on individual animals
Irritation parameter:
other: Conjunctivae Discharge
Basis:
mean
Time point:
other: 24 h
Score:
>= 0.5 - <= 2.5
Max. score:
2.5
Reversibility:
not specified
Remarks on result:
other: no data on individual animals
Irritation parameter:
other: Conjunctivae Discharge
Basis:
mean
Time point:
other: 48 h
Score:
>= 0.5 - <= 2
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: no data on individual animals
Irritation parameter:
other: Conjunctivae Discharge
Basis:
mean
Time point:
other: 72 h
Score:
>= 0.5 - <= 2
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: no data on individual animals
Irritant / corrosive response data:
- varying degrees of conjunctival irritation in each animal at each observation level
- slight to marked redness, moderate to marked chemosis, very slight to moderate discharge
- no corneal damage

Any other information on results incl. tables

Table 1: Eye irritiation in the rabbit caused by Lupersol 223 (Di-(2-Ethylhexyl)Peroxydicarbonate)

Ocular area

Eye irritation in the rabbit

Observation period and average score (range)

24h

48h

72 h

Cornea

A

0

0

0

B

0

0

0

Cornea score

 

0

0

0

Iris

A

0

0

0

Iris score

 

0

0

0

Conjunctivae

A

2.2

(2.0-2.5)

2.1  (1.0-2.5)

1.8       (1.0-3.0)

B

3.8

(3.0-4.0)

3.6  (3.0-4.0)

3.7 (3.0-4.0)

C

1.3 (0.5-2.5)

1.1  (0.5-2.0)

1.0  (0.5-2.0)

Conjunctivae score

 

14.6

13.6

13.0

Total score

 

14.6

13.6

13.0

A: Redness

B: Chemosis

C: Discharge

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results Lupersol 223 would be considered an eye irritant.
Executive summary:

Lupersol 223 (Di-(Ethylhexyl)Peroxydicarbonate) was tested in 3 male and 3 female rabbits (New Zealand white) for eye irritation. An amount of 0.1 ml of the test substance was instilled into the conjunctival sac of the right eye of each rabbit. The eyes were not washed. Examinations were made after 24, 48 and 72 h and scored according Draize et al. 1959. Varying degrees of conjunctival irritation were observed in each test animal at each observation interval. These findings included slight to marked redness, moderate to marked chemosis and very slight to moderate discharge. Examination of the treated eyes at 72 h with UV light and sodium fluorescein did not reveal corneal damage. Adverse effects were observed but the observation period was not extended to 21 days to exclude a chronic effect. No data of the individually tested animals are provided but the average score. In this study Lupersol 223 (Di-(Ethylhexyl)Peroxydicarbonate) is an eye irritant.