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EC number: 287-820-4 | CAS number: 85586-18-1
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted in accordance with international guidelines and in accordance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Monitoring authority
Test material
- Reference substance name:
- Fatty acids, C18-unsatd., reaction products with acrylic acid and polyethylenepolyamines
- EC Number:
- 287-820-4
- EC Name:
- Fatty acids, C18-unsatd., reaction products with acrylic acid and polyethylenepolyamines
- Cas Number:
- 85586-18-1
- Molecular formula:
- Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)
- IUPAC Name:
- (Z,9Z)-N-(2-{2-[(8Z)-heptadec-8-en-1-yl]-4,5-dihydro-1H-imidazol-1-yl}ethyl)octadec-9-enimidic acid; 3-[(2-carboxyethyl)({2-[3-(2-carboxyethyl)-2-[(8Z)-heptadec-8-en-1-yl]imidazolidin-1-yl]ethyl})amino]propanoic acid; 3-{2-[(8Z)-heptadec-8-en-1-yl]-3-{2-[(E)-[(9Z)-1-hydroxyoctadec-9-en-1-ylidene]amino]ethyl}imidazolidin-1-yl}propanoic acid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Three New Zealand white supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK were used. At the start of the study the animals weighed 2.65 to 2.74 Kg and were twelve to sixteen weeks old. After a minimal acclimatization period of five days each animal was given a unique study number, which was written with a black indelible marker pen on the inner surface of the ear and the cage label.
The animals were individually housed in suspended metal cages. Free access to mains drinking water and food (Stanrab SQC rabbit diet) from Special Diets Lrd, Witham, Essex was allowed throughout the study
The temperature and relative humidity were set to achieve limits of 17 to 23 degrees centigrade and 30 and 70 percent respectively. Any occasional deviations were considered not to have affected the purpose or integrity of the study. The rate of air exchange was approximately 15 changes per hour and lighting was controlled to give twelve hours continuous light and twelve hours of darkness.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- A volume of 0.1ml undiluted test material
- Duration of treatment / exposure:
- 1 second
- Observation period (in vivo):
- Assessment of occular damage/irritation was made approximately 1-hour, 24, 48, 72 hours and 7 days following treatment
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- One animal was initially treated. A volume of 0.1ml of the test material was instilled into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after instillation, to prevent loss of the test material and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain reaction was made.
After consideration of the ocular response produced in the first treated animal, an additional two animals were treated in a similar fashion. However in order to minimize pain on instillation of the test material, one drop of local anaesthetic (Ametocaine Hydrochloride 0.5%, Chauvin Pharmaceuticals, Romford, Essex, UK) was instilled into both eyes of these animals 1 to 2 minutes before treatment.
Assessment of ocular damage/irritation was made approximately 1-hour, 24, 48 and 72 hours following treatment. Ocular irritation was assessed using the methodology developed by Draize JH (1977) and reported in “Dermal and eye toxicity tests” In: Principles and Procedures for evaluating the toxicity of Household substances National Academy of Sciences, Washington DC P. 48-49.
Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
An additional observation was made in one treated eye on Day 7 to assess the reversibility of the ocular effects.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1-hour
- Score:
- 12
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 24-hour
- Score:
- 9.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 48-hour
- Score:
- 4
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 72-hour
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 7-day
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 12
- Max. score:
- 12
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The test material, PR-4758 produced a maximum group mean score of 12.0 and was classified as a MILD IRRITANT to the rabbit eye according to a modified Kay and Calandra classification system.
Individual and group mean scores for ocular irritation were noted during the study. No corneal or irial effects were noted. Moderate conjunctival irritation was noted in all treated eyes at 1 and 24-hour observations with minimal to moderate conjuncitval irritation at the 48-hour observation. Minimal conjuncitval redness was noted in one treated eye at the 72-hour observation.
Two treated eyes appeared normal at the 72-hour observation and one treated eye appeared normal at the 7-day observation. - Other effects:
- None noted
Any other information on results incl. tables
Individual scores and individual total scores for ocular irritation
| Rabbit # and Sex (Bodyweight Kg) |
IPR = 3 | IPR = 0 + | IPR = 0 + | ||||||||||
| 4 Female (2.74) |
107 Female (2.65) |
108 Male (2.66) |
|||||||||||
| Time after treatment | 1-hr | 24-hr | 48-hr | 72-hr | 7-day | 1-hr | 24-hr | 48-hr | 72-hr | 1-hr | 24-hr | 48-hr | 72-hr |
| Cornea | |||||||||||||
| Degree of opacity (E) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Area of opacity (F) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Score (ExF) x 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Iris | |||||||||||||
| D | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Score (D x 5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Conjunctivae | |||||||||||||
| Redness (A) | 2 | 2 | 2 | 1 | 0 | 2 | 2 | 1 | 0 | 2 | 2 | 1 | 0 |
| Chemosis (B) | 2 | 2 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 2 | 1 | 0 | 0 |
| Discharge ( C ) | 2 | 2 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 2 | 1 | 0 | 0 |
| Score (A+B+C) x 2 | 12 | 12 | 8 | 2 | 0 | 12 | 8 | 2 | 0 | 12 | 8 | 2 | 0 |
| Total Score | 12 | 12 | 8 | 2 | 0 | 12 | 8 | 2 | 0 | 12 | 8 | 2 | 0 |
Where IPR = Initial pain response and + = 1 drop of Amethocaine Hydrochloride instillation
Individual Total scores and group mean scores for ocular irritation
| Rabbit # and Sex (Bodyweight Kg) |
Individual total Scores | ||||
| 1-hr | 24-hr | 48-hr | 72-hr | 7-d | |
| 4 Female (2.74) |
12 | 12 | 8 | 2 | 0 |
| 107 Female (2.65) |
12 | 8 | 2 | 0 | - |
| 108 Male (2.66) |
12 | 8 | 2 | 0 | - |
| Group total | 36 | 28 | 12 | 2 | 0 |
| Group mean score | 12.0 | 9.3 | 4.0 | 0.7 | 0.0 |
- = Observation not required
Individual Mean scores for Cornea, Iris and conjunctiva
| Rabbit # and Sex (Bodyweight Kg) |
Time after treatment | Corneal opacity | Iridial imflammation | Conjunctival irritation | Conjunctivital chemosis |
| 4 Female (2.74) |
24-hr | 0 | 0 | 2 | 2 |
| 48-hr | 0 | 0 | 2 | 1 | |
| 72-hr | 0 | 0 | 1 | 0 | |
| Total | 0 | 0 | 5 | 3 | |
| Mean | 0 | 0 | 1.7 | 1 | |
| 107 Female (2.65) |
24-hr | 0 | 0 | 2 | 1 |
| 48-hr | 0 | 0 | 1 | 0 | |
| 72-hr | 0 | 0 | 0 | 0 | |
| Total | 0 | 0 | 3 | 1 | |
| Mean | 0 | 0 | 1 | 0.3 | |
| 108 Male (2.66) |
24-hr | 0 | 0 | 2 | 1 |
| 48-hr | 0 | 0 | 1 | 0 | |
| 72-hr | 0 | 0 | 0 | 0 | |
| Total | 0 | 0 | 3 | 1 | |
| Mean | 0 | 0 | 1 | 0.3 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material, PR-4758 produced a maximum group mean score of 12.0 and was classified as a MILD IRRITANT to the rabbit eye according to a modified Kay and Calandra classification system.
- Executive summary:
At the request of Nalco Exxon Ltd, Safepharm Laboratories Ltd performed an acute eye irritation/corrosion study in accordance with Method B5 of Commision directive 92/69/EEC on PR-4758. The study was in compliance with Good laboratory practice. 0.1ml of PR-4758 was instilled into one eye of three healthy New Zealand White rabbits and their responses to the test material monitored and scored 1-hour, 24, 48, 72 hours and 7-days post exposure. The study indicates that PR-4758 produced a maximum group mean score of 12 and was classified as a mild irritant to the rabbit eye in accordance with the Kay and Calandra classification system.
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