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EC number: 203-315-3 | CAS number: 105-62-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 21 May - 24 May 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP-Guideline study, tested with the source substance Fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol (CAS No. 84988-75-0). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (Dec 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report Date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): trade name
- Chemical denomination: fatty acids, C14-18 and C16-18 unsaturated, ester with propylene glycol
- Physical state: yellowish solid substance
- Analytical purity: 100% content of active substance
- Lot/batch No.: 0130 (from January 16, 1991)
- Expiration date of the lot/batch: 1991-07-16
- Stability under test conditions: stable for at least 1.5 years
- Storage condition of test material: at room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleinrussen, Chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: 4 months
- Weight at study initiation: 2370 g
- Housing: individually housed in cages (E. Becker & Co)
- Diet: Ssniff rabbit diet K4 Charge: 66029126 (Ssniff GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 male
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was rinsed with tepid tap water.
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 71 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Cornea/ Iris: No effects on cornea/iris were observed in any animal during the study period.
Conjunctivae: After 1 and 24 h 2/3 animals showed slight erythema being fully reversible within 48 h.
Chemosis: In 1/3 animals slight chemosis was observed after 1 h being fully reversible within 24 h. No further edema formation was observed during the study period in any animal. - Other effects:
- No further local or system effects were reported.
Any other information on results incl. tables
Table 1. Results of eye irritation study.
Rabbit # | Time [h] | conjunctivae |
| iris | cornea |
redness | swelling | ||||
1 | 1 | 0 | 0 | 0 | 0 |
24 | 0 | 0 | 0 | 0 | |
48 | 0 | 0 | 0 | 0 | |
72 | 0 | 0 | 0 | 0 | |
average | 0.0 | 0.0 | 0.0 | 0.0 | |
2 | 1 | 1 | 0 | 0 | 0 |
24 | 1 | 0 | 0 | 0 | |
48 | 0 | 0 | 0 | 0 | |
72 | 0 | 0 | 0 | 0 | |
average | 0.3 | 0.0 | 0.0 | 0.0 | |
3 | 1 | 1 | 1 | 0 | 0 |
24 | 1 | 0 | 0 | 0 | |
48 | 0 | 0 | 0 | 0 | |
72 | 0 | 0 | 0 | 0 | |
average | 0.3 | 0.0 | 0.0 | 0.0 | |
|
| ||||
Time [h] | conjunctivae |
| iris | cornea | |
| redness | swelling |
|
| |
average | 1 | 0.67 | 0.33 | 0.00 | 0.00 |
24 | 0.67 | 0.00 | 0.00 | 0.00 | |
48 | 0.00 | 0.00 | 0.00 | 0.00 | |
72 | 0.00 | 0.00 | 0.00 | 0.00 | |
24+48+72 | 0.22 | 0.00 | 0.00 | 0.00 | |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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