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Registration Dossier
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EC number: 272-810-4 | CAS number: 68915-38-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: According to guideline with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- only 8 days observation period
- GLP compliance:
- no
Test material
- Reference substance name:
- Cyclohexane, oxidized, aquous extract
- IUPAC Name:
- Cyclohexane, oxidized, aquous extract
- Reference substance name:
- Cyclohexane, oxidized, aq. ext.
- EC Number:
- 272-810-4
- EC Name:
- Cyclohexane, oxidized, aq. ext.
- Cas Number:
- 68915-38-8
- Molecular formula:
- not available
- IUPAC Name:
- Cyclohexane, oxidized, aq. ext.
- Details on test material:
- - Name of test material (as cited in study report): Abstreifsaeure
- Physical state: Yellow liquid
- Composition of test material, percentage of components:
16.7% Adipinic acid (CAS-Nr. 12404-9)
13.2% 6-Hydroxycaproic acid (CAS-Nr.1191-25-9)
2.1% Glutaric acid (CAS-Nr. 110-94-1 )
0.8% succinic acid (CAS-Nr. 13392-69-3)
0.2% valeric acid (CAS-Nr. 109-52-4)
0.2% butanoic acid (CAS-Nr. 107-92-6)
0.1% propionic acid (CAS-Nr. 79-09-4)
0.3% acidic acid (CAS-Nr. 64-19-7)
1.4% formic acid (CAS-Nr. 64-18-6)
10% polymeric oxycaproic acid
~20ppm cobalt0.2% valeric acid
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach
- Mean weight at study initiation: male 2.89 Kg, female 2.73 Kg
- Housing: single
- Diet: Kliba 341 (about 130 g/animal/day)
- Water: 250 ml tap water/animal/day
- Acclimation period: 8 days
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 the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- kept unwashed
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize scoring. Readings: 1h, 24h, 48h, 72h and 8 days after application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24-48-72 h
- Score:
- 2.8
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: see free text for details
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24-48-72 h
- Score:
- 1.6
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: see free text for details
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24-48-72 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: see free text for details
Any other information on results incl. tables
Readings |
Animal |
Cornea |
Iris |
Conjuctiva |
Symptoms |
|
Red |
Sw |
|||||
1 h |
1 |
1 |
0 |
2 |
2 |
- |
2 |
1 |
0 |
2 |
2 |
- |
|
3 |
1 |
0 |
2 |
2 |
LC |
|
24 h |
1 |
2 |
0 |
2 |
1 |
PC/LC |
2 |
3 |
0 |
1 |
2 |
LC |
|
3 |
2 |
0 |
1 |
1 |
PC/LC |
|
48 h |
1 |
2 |
0 |
2 |
1 |
PC/LC/S |
2 |
4 |
0 |
1 |
2 |
LC/S |
|
3 |
3 |
0 |
2 |
1 |
PC/LC |
|
72 h |
1 |
2 |
0 |
2 |
1 |
PC/LC/S/RE |
2 |
4 |
0 |
1 |
2 |
LC/S |
|
3 |
3 |
0 |
2 |
1 |
PC/LC/RE |
|
8 d |
1 |
2 |
0 |
2 |
1 |
MV/LH/PA/RE/SO6/PC/LC |
2 |
4 |
0 |
1 |
2 |
MV/PA/RE/LC/S/SO6 |
|
3 |
4 |
0 |
2 |
1 |
PC/LC/RE/MV/SO6 |
|
Mean (24-72 h) |
1 |
2.0 |
0 |
2.0 |
2.0 |
|
2 |
3.7 |
0 |
1.0 |
1.0 |
|
|
3 |
2.7 |
0 |
1.7 |
1.7 |
|
|
Mean |
|
2.8 |
0 |
1.6 |
1.6 |
|
Red
- redness
Sw - chemosis
LC - loss of corneal tissue
PC - pupil contracted
S - suppuration
RE - small retractions in the eyelid
MV - marginal vascularization of the cornea
LH - loss of hair at margins of the eyelid
PA - pannus
SO6 - study discontinued after 8d because of severe irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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