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EC number: 629-850-6 | CAS number: 1245638-61-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From October 27, 1980 to November 10, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the equivalent of standard guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Method: 40 CFR Part 163.81-4 (ENVIRONMENTAL PROTECTION AGENCY PESTICIDE PROGRAMS. Proposed Guidelines for Registering Pesticides in the U.S.; Hazard Evaluation: Humans and Domestic Animals. Primary Eye Irritation Study).
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-Propenoic acid, reaction products with pentaerythritol
- EC Number:
- 629-850-6
- Cas Number:
- 1245638-61-2
- Molecular formula:
- Not available for this UVCB.
- IUPAC Name:
- 2-Propenoic acid, reaction products with pentaerythritol
- Details on test material:
- Name of test material (as cited in study report): SN-2196, C-171, JAB 318-80
Physical state: Viscous, clear liquid
Density: 1.1788 g/mL
Storage condition of test material: Stored at 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: Dutchland Laboratory Animals, Denver, Pennsylvania
- Age at study initiation: Young adults
- Weight at study initiation: 2.8 - 3.5 kg
- Housing: Individually housed in suspended, stainless steel
- Diet (e.g. ad libitum): Purina Rabbit Chow, ad libitum
- Water (e.g. ad libitum): Municipal water supply (Elizabethtowm Water Co.), ad libitum
- Acclimation period: 35 d
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 64 - 67 °F
- Photoperiod (h dark / h light): 12 h dark / 12 h light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single exposure, eyes washed 20 sec post-instillation in 3/9 rabbits
- Observation period (in vivo):
- 14 d
- Number of animals or in vitro replicates:
- Nine
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Both eyes of 3/9 rabbits were rinsed with lukewarm water for 1 min
- Time after start of exposure: 20 sec
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: Fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: in all nine animals
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: in all nine animals
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 d in 2/3 animals with rinsed eyes
- Remarks on result:
- other: iris score could not be evaluated in 6 animals (eyes without rinsing) because of severe response
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.91
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- in 4/6 animals (eyes without rinsing)
- Remarks on result:
- other: cornea score could not be evaluated in 2/6 animals because of severe response
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.56
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d in 2/3 animals with rinsed eyes
- Irritant / corrosive response data:
- Test material caused extensive ocular damage. Response was so severe that many parameters in the animals with non-rinsed eyes could not be evaluated: these animals were sacrificed at day 7 for humane reasons. Animals with rinsed eyes exhibited positive scores for all parameters (conjunctival redness, chemosis, necrosis and ulceration, corneal opacity and ulceration, and iridial damage). All three animals exhibited pannus and continued to exhibit signs of irritation at termination of the observation period (day 14).
- Other effects:
- No data
Any other information on results incl. tables
Table 1: Mean ocular irritation scores observed at 24, 48 and 72 h
| Animal No. | Corneal opacity | Iritis | Conjunctivae | Chemosis |
| 1 | 3.67 | NE | 3 | 4 |
| 2 | NE | NE | 3 | 4 |
| 3 | NE | NE | 3 | 4 |
| 4 | 4 | NE | 3 | 4 |
| 5 | 4 | NE | 3 | 4 |
| 6 | 4 | NE | 3 | 4 |
| 7* | 2.67 | 1 | 3 | 4 |
| 8* | 2 | 1 | 3 | 4 |
| 9* | 3 | 1 | 3 | 4 |
* Eyes in three rabbits rinsed with lukewarm water 20 sec post-instillation for 60 sec
NE: NE-Not evaluated - evaluation not possible because of severity of response
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the study, the test substance was found to be extremely irritating to the rabbit eye.
- Executive summary:
A study was conducted to evaluate the eye irritation potential of C-171in rabbit eyes. The study performed was similar to OECD Guideline 405.
0.1 mL of the substance was instilled into the right eye of nine rabbits; the left eye served as an untreated control. One group of six rabbits received no further treatment. In the second group, three rabbits eyes were rinsed 20 s post-instillation for 60 s. Irritation was scored by the Draize scoring system at 24, 48 and 72 h and 4, 7, 9, 11 and 14 d post-instillation.
The substance caused extensive eye damage. Response was so severe that many parameters in animals with non-rinsed eyes could not be evaluated: these animals were sacrificed at Day 7 for humane reasons. Animals with rinsed eyes exhibited positive scores for all parameters (conjunctival redness, chemosis, necrosis and ulceration, corneal opacity and ulceration, and iridial damage). All three animals exhibited pannus and continued to exhibit signs of irritation at termination of the observation period (Day 14).
In conclusion, under the conditions of the study, the test substance was found to be extremely irritating to the rabbit eye.
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