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EC number: - | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02/08/1991-28/11/1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- According to the OECD Guideline and in compliance with GLP
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
- 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:
- Fatty alcohols C13-15 (odd numbered, linear and branched), reaction products with ethylene oxide, sodium chloroacetate and ethanolamine
- Molecular formula:
- R-O-(CH2CH2O)nCH2CO-NH-CH2CH2OH
- IUPAC Name:
- Fatty alcohols C13-15 (odd numbered, linear and branched), reaction products with ethylene oxide, sodium chloroacetate and ethanolamine
- Test material form:
- liquid
- Details on test material:
- - Physical state: clear yellow liquid
- Storage conditions: between 20-30°C in the dark
- Stability under test conditions: stable
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 73 weeks
- Weight at study initiation: 2214-2789 g
- Housing: Individually in labelled cages, with perforated floors and equipped with an automatic drinking system.
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands), approx.100 gram per day.
- Water (e.g. ad libitum): free access to tap water diluted with decalcified water.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 1, 24, 48 and 72 hours and 7 days after instillation of test material
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not reported
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Instillation of the test substance into one eye of each of three female albino rabbits affected the iris and conjunctivae of all three animals. The injection of the iris had resolved within 24 hours and the irritation of the conjunctivae had resolved within 7 days in all three animals.
Treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.
There was no evidence of ocular corrosion. - Other effects:
- No toxic symptoms were observed in the animals during the test period and no mortality occured.
Any other information on results incl. tables
Individual findings:
| Animal No. 736 | ||||
| Time after instillation | Tissue | Score | Fluor. Area % | Comments |
| 1 hour | Corneal opacity | 0 | Redness grade 2 for scleral conjunctivae. Chemosis grade 2 for nictating membrane. Lacrimation was observed. |
|
| area | 0 | |||
| Iris | 1 | |||
| Conj. Redness | 2 | |||
| chemosis | 2 | |||
| Discharge | 1 | |||
| 24 hours | Corneal opacity | 0 | 0 | |
| area | 0 | |||
| Iris | 0 | |||
| Conj. Redness | 2 | |||
| chemosis | 1 | |||
| Discharge | 1 | |||
| 48 hours | Corneal opacity | 0 | Chemosis grade 1 for nictating membrane. | |
| area | 0 | |||
| Iris | 0 | |||
| Conj. Redness | 2 | |||
| chemosis | 1 | |||
| Discharge | 1 | |||
| 72 hours | Corneal opacity | 0 | ||
| area | 0 | |||
| Iris | 0 | |||
| Conj. Redness | 1 | |||
| chemosis | 0 | |||
| Discharge | 0 | |||
| 7 days | Corneal opacity | 0 | ||
| area | 0 | |||
| Iris | 0 | |||
| Conj. Redness | 0 | |||
| chemosis | 0 | |||
| Discharge | 0 | |||
| Animal No. 737 | ||||
| Time after instillation | Tissue | Score | Fluor. Area % | Comments |
| 1 hour | Corneal opacity | 0 | Lacrimation was observed. | |
| area | 0 | |||
| Iris | 1 | |||
| Conj. Redness | 1 | |||
| chemosis | 2 | |||
| Discharge | 1 | |||
| 24 hours | Corneal opacity | 0 | 0 | Lacrimation was observed. |
| area | 0 | |||
| Iris | 0 | |||
| Conj. Redness | 2 | |||
| chemosis | 1 | |||
| Discharge | 1 | |||
| 48 hours | Corneal opacity | 0 | Chemosis grade 1 for nictating membrane. | |
| area | 0 | |||
| Iris | 0 | |||
| Conj. Redness | 2 | |||
| chemosis | 1 | |||
| Discharge | 1 | |||
| 72 hours | Corneal opacity | 0 | Redness grade 2 for scleral conjunctivae. | |
| area | 0 | |||
| Iris | 0 | |||
| Conj. Redness | 2 | |||
| chemosis | 0 | |||
| Discharge | 0 | |||
| 7 days | Corneal opacity | 0 | ||
| area | 0 | |||
| Iris | 0 | |||
| Conj. Redness | 0 | |||
| chemosis | 0 | |||
| Discharge | 0 | |||
| Animal No. 738 | ||||
| Time after instillation | Tissue | Score | Fluor. Area % | Comments |
| 1 hour | Corneal opacity | 0 | Redness grade 2 for scleral conjunctivae. Lacrimation was observed. |
|
| area | 0 | |||
| Iris | 1 | |||
| Conj. Redness | 2 | |||
| chemosis | 2 | |||
| Discharge | 1 | |||
| 24 hours | Corneal opacity | 0 | 0 | Lacrimation was observed. |
| area | 0 | |||
| Iris | 0 | |||
| Conj. Redness | 2 | |||
| chemosis | 1 | |||
| Discharge | 1 | |||
| 48 hours | Corneal opacity | 0 | Lacrimation was observed. | |
| area | 0 | |||
| Iris | 0 | |||
| Conj. Redness | 2 | |||
| chemosis | 1 | |||
| Discharge | 2 | |||
| 72 hours | Corneal opacity | 0 | Redness grade 2 for scleral conjunctivae. | |
| area | 0 | |||
| Iris | 0 | |||
| Conj. Redness | 2 | |||
| chemosis | 1 | |||
| Discharge | 1 | |||
| 7 days | Corneal opacity | 0 | ||
| area | 0 | |||
| Iris | 0 | |||
| Conj. Redness | 0 | |||
| chemosis | 0 | |||
| Discharge | 0 | |||
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- Under the test conditions, the test material is classified as H319 "Causes serious eye irritation" Category 2 according to the Regulation (EC) No. 1272/2008 (CLP) and Category 2B according to the GHS.
- Executive summary:
In an eye irritation study performed according to the OECD Guideline No. 405, and in compliance with GLP, 0.1 mL of undiluted test material was instilled into one eye of 3 female New Zealand White rabbits following a sequential testing strategy. The other eye remained untreated and served as control. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test material, and then released. The eyes were examined and the changes were observed at 1, 24, 48, 72 h and 7 days after treatment and graded according to the Draize method.
Instillation of the test substance into one eye of each of three female albino rabbits affected the iris and conjunctivae of all three animals. The injection of the iris had resolved within 24 hours and the irritation of the conjunctivae had resolved within 7 days in all three animals.
Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0 / 0 / 0 for cornea score; 0 / 0 / 0 for iris score; 1.7 / 2.0 / 2.0 for conjunctivae score and 0.7 / 0.7 / 1.0 for chemosis score.
Under the test conditions, the test material is classified as H319 "Causes serious eye irritation" Category 2 according to the Regulation (EC) No. 1272/2008 (CLP) and Category 2B according to the GHS.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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