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EC number: 309-629-8 | CAS number: 100545-48-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 24 May 2012 to 01 June 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:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine
- EC Number:
- 309-629-8
- EC Name:
- Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine
- Cas Number:
- 100545-48-0
- Molecular formula:
- No discrete molecular formula available for this UVCB substance
- IUPAC Name:
- Reaction products of 12-hydroxyoctadecanoic acid with ethane-1,2-diamine
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: breeder: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age/weight at study initiation: the animals were 12 to 20 weeks old at the beginning of the study and their body weight ranged from 2.62 to 3.01 kg.
- Fasting period before study: no
- Housing: the animals were individually housed in suspended cages
- Diet: 2930C Teklad Global Rabbit diet (free access)
- Water: free access
- Acclimation period: at least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 15 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h.
IN-LIFE DATES: 24 May 2012 to 01 June 2012.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other untreated eye served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test substance (which was found to weigh approximately 66 mg)
- Concentration: Undiluted
VEHICLE
-none - Duration of treatment / exposure:
- Not applicable: single application not followed by rinsing.
- Observation period (in vivo):
- The eyes were examined for any ocular reaction approximately 1, 24, 48, and 72 h after the treatment.
- Number of animals or in vitro replicates:
- Two
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM:
- Draize scale for scoring ocular Irritation (Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).
TOOL USED TO ASSESS SCORE:
- Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- - No corneal or iridial effects were noted during the study.
- Minimal conjunctival irritation was noted in both the animals 1 and 24 hours after treatment and in one animal at the 48 hour observation. However, these effects were reversible within 48 hours in one animal and within 72 hours in the other animal. - Other effects:
- No bodyweight gain was noted in one animal and the other animal showed expected gain in bodyweight during the study.
Any other information on results incl. tables
Table 7.3.2/1 Individual Scores and individual total Scores for ocular irritation
| Rabbit Number and Sex | 72058 Male | 72080 Male | ||||||
| Time after treatment | 1 h | 24 h | 48 h | 72 h | 1 h | 24 h | 48 h | 72 h |
| CORNEA | ||||||||
| E = Degree of opacity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| F = Area of cornea involved | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Score (E x F) x 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| IRIS | ||||||||
| D | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Score (D x 5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| CONJUNCTIVAE | ||||||||
| A = Redness | 1 | 1 | 0 | 0 | 1 | 1 | 1 | 0 |
| B = Chemosis | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| C = Discharge | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Score (A + B + C) x 2 | 6 | 2 | 0 | 0 | 6 | 2 | 2 | 0 |
| Total Score | 6 | 2 | 0 | 0 | 6 | 2 | 2 | 0 |
Table 7.3.2/2 Individual Total Scores and Group Mean Scores for ocular irritation
| Rabbit Number and Sex | Individual total scores at: | |||
| 1 h | 24 h | 48 h | 72 h | |
| 72058 Male | 6 | 2 | 0 | 0 |
72080 Male |
6 | 2 | 2 | 0 |
| Group Total | 12 | 4 | 2 | 0 |
| Group Mean Score | 6.0 | 2.0 | 1.0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance produced minimal conjunctival irritation when applied into rabbit eye.
- Executive summary:
The potential of the test item to induce eye irritation was assessed in rabbits according to OECD Guideline 404 in compliance with Good Laboratory Practice.
A volume of 0.1 mL of the test substance was placed into the conjunctival sac of the right eye of two New Zealand White rabbits without irrigation. The left eye remained untreated and was used for control purposes. Assessment of ocular damage/irritation was made 1, 24, 48 and 72 hours following treatment according to the Draize scoring method.
No corneal or iridial effects were noted during the study. Minimal conjunctival irritation was seen in both animals 1 and 24 hours after treatment and in one animal at the 48 hour observation. These effects were reversible within 48 hours in one animal and within 72 hours in the other.
It was concluded that the test item produced minimal conjunctival irritation when applied into rabbit eye.
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