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EC number: 226-285-3 | CAS number: 5343-92-0
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:
- other: Guideline study (OECD)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- DEPARTMENT OF TOXICOLOGY, BASF AG
Test material
- Reference substance name:
- Pentane-1,2-diol
- EC Number:
- 226-285-3
- EC Name:
- Pentane-1,2-diol
- Cas Number:
- 5343-92-0
- Molecular formula:
- C5H12O2
- IUPAC Name:
- pentane-1,2-diol
- Details on test material:
- - Name of test material (as cited in study report): 1,2-Pentandiol
- Test substance number: 91/369
- Physical state: liquid, achromatic
- Lot/batch No.: Abl. No. 49-0372
- Date of manufacturing: July 1991
- Storage condition of test material: room temperature
- Analytical purity: > 99%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; D-W6050 Offenbach, Germany
- Identification: ear tattoo
- Age at study initiation: Young adult animals
- Weight at study initiation: 3.15 kg (male), 3.49 kg (male), 303 kg (female)
- Housing: individually in cage made of stainless steel with wire mesh walk floors (floor area: 40 cm x 51 cm); No bedding in the cages; sawdust in the waste trays
- Diet (e.g. ad libitum): ad libitum, KLIBA Labordiät 341, 4 mm; Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (e.g. ad libitum): ad libitum, about 250 ml tap water per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- 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:
- 21 d
- Observation period (in vivo):
- 21 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM:
ACCORDING TO OECD GUIDELINE 405 (ADOPTED FEB 24, 1987) AND EEC L 251, B.5 (SEPT 19, 1984):
CORNEA
Opacity: degree of density (area most dense taken for reading):
0 = no ulceration or opacity
1 = Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 = easily discernible translucent area, details of iris slightly obscured
3 = Nacrous area, no details of iris visible, size of pupil barely discernible
4 = Opaque cornea, iris not discernible through the opacity
Area of cornea involved (AR):
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 or combination of any thereof,
iris still reacting to light (sluggish reaction is positive)
2 = No reaction to light, haemorrhage, gross destruction (any or all of these)
CONJUNCTIVAE
Redness (refers to palpebral and bulbarconjunctivae, 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: lids and/or nictating membranes:
0 = No swelling
1 = Any swelling above normal (includes nictating membranes)
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half closed
4 = Swelling with lids more than half closed
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.8
- Max. score:
- 2
- Reversibility:
- fully reversible within: 15 d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 2.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
Any other information on results incl. tables
Results:
animal 1: male, 3.15 kg
animal 2: male, 3.49 kg
animal 3: female, 3.03 kg
| Readings | Animal | cornea | Iris | conjunctiva | Symptons | |||
| opacity | area | redness | swelling | discharge | ||||
| 1h | 1 | 1 | 2 | 0 | 2 | 3 | 3 | pc, lc |
| 2 | 1 | 3 | 0 | 2 | 3 | 2 | lc | |
| 3 | 1 | 2 | 0 | 2 | 3 | 2 | lc | |
| 24 h | 1 | 1 | 2 | 0 | 2 | 2 | 2 | pc, lc |
| 2 | 1 | 3 | 1 | 2 | 2 | 1 | lc | |
| 3 | 1 | 4 | 0 | 2 | 2 | 2 | db | |
| 48 h | 1 | 1 | 2 | 1 | 3 | 1 | 2 | pc, db, lc |
| 2 | 1 | 3 | 1 | 3 | 2 | 2 | db | |
| 3 | 1 | 4 | 1 | 3 | 2 | 2 | sr, pc, db | |
| 72 h | 1 | 1 | 4 | 1 | 2 | 1 | 1 | rs, s, pc |
| 2 | 1 | 3 | 1 | 3 | 2 | 1 | sr, pc, db | |
| 3 | 1 | 4 | 1 | 3 | 2 | 3 | sr, pc, db | |
| 8 d | 1 | 1 | 3 | 0 | 0 | 0 | 0 | sr, pc, lc |
| 2 | 2 | 1 | 0 | 2 | 0 | 0 | sr, lc | |
| 3 | 2 | 2 | 1 | 3 | 1 | 2 | sr, pc, mv, lc | |
| 15 d | 1 | 1 | 3 | 0 | 0 | 0 | 0 | sr, pc, mv, lc |
| 2 | 1 | 1 | 0 | 0 | 0 | 0 | sr, mv, lc | |
| 3 | 2 | 1 | 0 | 2 | 1 | 1 | sr,s, pc, mv, lc | |
| 21 | 1 | 1 | 3 | 0 | 0 | 0 | 0 | sr, pc, mv, lc |
| 2 | 1 | 1 | 0 | 0 | 0 | 0 | sr, lc | |
| 3 | 2 | 1 | 0 | 1 | 1 | 1 | sr, s, mv, lc | |
| Mean 24 - 72 h | 1 | 1.0 | 0.7 | 2.3 | 1.3 | |||
| 2 | 1.0 | 1.0 | 2.7 | 2.0 | ||||
| 3 | 1.0 | 0.7 | 2.7 | 2.0 | ||||
| Mean | 1.0 | 0.8 | 2.6 | 1.8 | ||||
SR: SMALL RETRACTIONS IN THE EYELIDS
S: SUPPURATION
PC: PUPIL CONTRACTE D
MV: MARGINAL VASCULARIZATION OF THE CORNEA
DB: DISCHARGE OF BLOOD
LC: LOSS OF CORNEAL TISSUE
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification: irritating
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