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Registration Dossier
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EC number: 240-282-4 | CAS number: 16111-62-9
Eye irritation
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:
- 1 970
- Report date:
- 1970
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- 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 substance name:
- Bis(2-ethylhexyl) peroxydicarbonate
- EC Number:
- 240-282-4
- EC Name:
- Bis(2-ethylhexyl) peroxydicarbonate
- Cas Number:
- 16111-62-9
- Molecular formula:
- C18H34O6
- IUPAC Name:
- 3-({[({[(2-ethylhexyl)oxy]carbonyl}peroxy)carbonyl]oxy}methyl)heptane
- Reference substance name:
- Di-(2-Ethylhexyl)Peroxydicarbonate
- IUPAC Name:
- Di-(2-Ethylhexyl)Peroxydicarbonate
- 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
Constituent 1
Constituent 2
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.
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