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EC number: 281-978-8 | CAS number: 84082-30-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2013
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
- GLP compliance:
- yes
Test material
- Reference substance name:
- Rape oil, sulfated, sodium salt
- EC Number:
- 281-978-8
- EC Name:
- Rape oil, sulfated, sodium salt
- Cas Number:
- 84082-30-4
- Molecular formula:
- not available (substance is a UVCB)
- IUPAC Name:
- Rape oil, sulfated, sodium salt
- Details on test material:
- - Name of test material : CP12
- Physical state: Liquid
- Lot/batch No.: 0012
- Expiration date of the lot/batch: 2015-08-01
- Storage condition of test material: Room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia S.p.A.
- Age at study initiation: 15 - 17 weeks
- Weight at study initiation: 2.9 kg
- Housing: conventional, singly housed in metal cages with perforated noryl floors
- Diet (e.g. ad libitum): Stanrab (P) from Special Diet Services UK, ad libitum
- Water (e.g. ad libitum): Municipal supply ad libitum
- Acclimation period: at least 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2012-10-15 To: 2012-11-05
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours, 7, 14 and 21 days after application
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
SCORING SYSTEM: Draize scale, according to test guideline
TOOL USED TO ASSESS SCORE: None
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritant / corrosive response data:
- Response was assessed in a single animal. Well defined conjunctival chemosis and moderate redness were observed 1, 24 and 48 hours post-exposure. Seventy-two hours after exposure, slight chemosis and severe redness were observed. Slight redness was still observed after 7 and 14 days. Slight discharge and chemosis were noted after 14 days after dosing. Slight corneal opacity with the area of cornea involved greater than half was observed from 1 hour post-exposure up to the end of the observation period (21 days after treatment). The extension of the opacity gradually decreased from 48 hour post-exposure.
AVERAGE SCORE
- Cornea: 1.0
- Iris: 0.0
- Conjuntivae (Redness): 2.3
- Conjuntivae (Chemosis): 1.7
Any other information on results incl. tables
Irritant/corrosive response data at each observation time
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctival redness |
Conjunctival chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 minutes |
1 |
0 |
2 |
2 |
24 hours |
1 |
0 |
2 |
2 |
48 hours |
1 |
0 |
2 |
2 |
72 hours |
1 |
0 |
3 |
1 |
7 days |
1 |
0 |
1 |
0 |
14 days |
1 |
0 |
1 |
1 |
21 days |
1 |
0 |
0 |
0 |
Average 24, 48, 72 hours |
1.0 |
0.0 |
2.3 |
1.7 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Acute eye irritation has been investigated in the rabbit using methods in accordance with OECD/EU test guidelines. Significant irritation was observed that had not resolved within 21 days.
- Executive summary:
Acute eye irritation has been investigated in the rabbit using methods in accordance with OECD/EU test guidelines. Significant irritation was observed that had not resolved within 21 days.
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