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EC number: 258-469-4 | CAS number: 53306-54-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis(2-propylheptyl) phthalate
- EC Number:
- 258-469-4
- EC Name:
- Bis(2-propylheptyl) phthalate
- Cas Number:
- 53306-54-0
- Molecular formula:
- C28H46O4
- IUPAC Name:
- 1,2-bis(2-propylheptyl) benzene-1,2-dicarboxylate
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Strain / quality: New Zealand White A1077 INRA (SPF)
- Source: Centre Lago S.A., 01540 Vonnas, France
- Identification: Ear tattoo
- Age at study initiation: About 3 - 4 months
- Weight at study initiation: 2.82 kg -2.99 kg
- Housing: Single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm^2
- Diet (e.g. ad libitum): Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day); ad libitum
- Water (e.g. ad libitum): Tap water ad libitum; ad libitum
- Acclimation period: At least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Air changes (per hr): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- physiological saline
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 24 hour(s)
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 (2 females, 1 male)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, tap water
- Time after start of exposure: 24 h
SCORING SYSTEM:
The evaluation of eye irritation is performed according to the guidelines:
Cornea opacity (op): Degree of density (the most dense area is taken for reading)
0 = No ulceration or opacity
1 = Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible
2 = Easily discernible translucent area, details of iris slightly obscured
3 = Nacreous area, no details of iris visible, size of pupil barely discernible
4 = Opaque cornea, iris not discernible through the opacity
Area of cornea involved (the assessment of these ocular reactions is performed independent of the quoted guidelines):
1 = >0<=1/4
2 = >1/4<1/2
3 = >1/2<3/4
4 = >3/4
Iris:
0 = Normal
1 = Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these observations or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 = No reaction to Iight, haemorrhage, gross destruction (any or all of these)
Conjunctivae redness (red): Refers to palpebral and bulbar conjunctivae, cornea and iris
0 = Blood vessels normal
1 = Some blood vessels definitely hyperaemic (injected)
2 = Diffuse, crimson colour, individual vessels not easily discernible
3 = Diffuse beefy red
Chemosis (sw): Lids and/or nictitating membranes
0 = No swelling
1 = Any swelling above normal (includes nictitating membranes)
2 = Obvious swelling with partial eversion of lids
3 = SweIling with lids about half closed
4 = Swelling with Iids more than half closed
Discharge (the assessment of these ocular reactions is performed independent of the quoted guidelines):
0 = No discharge
1 = Any amount different from normal (does not include small amounts observed in inner
canthus of normal animals)
2 = Discharge with moistening of the lids and hairs just adjacent to lids
3 = Discharge with moistening of the lids and hairs, and considerable area around the eye
Description of any ocular findings not covered by this scale were recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Slight to moderate conjunctival redness (1 and 24 h) and slight discharge (1 h) were observed initially for 24 h at maximum. The ocular reactions were reversible in all animals within 48 hours after application. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity and for iris, 0.3 for conjunctival redness and 0.0 for chemosis.
Any other information on results incl. tables
Animal 1: female, 2.82 kg
Animal 2: male, 2.84 kg
Animal 3: female, 2.99 kg
Results.
| Readings | Animal | Cornea | Iris | Conjunctival | Symptoms | |||
| Opacity | Area | Erythema | Chemosis | Discharge | ||||
| 1h | 1 | 0 | 0 | 0 | 1 | 0 | 1 | |
| 2 | 0 | 0 | 0 | 2 | 0 | 1 | ||
| 3 | 0 | 0 | 0 | 1 | 0 | 1 | ||
| 24 h | 1 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 2 | 0 | 0 | 0 | 1 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 1 | 0 | 0 | ||
| 48 h | 1 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 72 h | 1 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| mean 24 - 72 h | 1 | 0.0 | 0.0 | 0.3 | 0.0 | |||
| 2 | 0.0 | 0.0 | 0.3 | 0.0 | ||||
| 3 | 0.0 | 0.0 | 0.3 | 0.0 | ||||
| mean | 1 | 0.0 | 0.0 | 0.3 | 0.0 | |||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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