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EC number: 440-860-8 | CAS number: 85633-96-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 440-860-8
- EC Name:
- -
- Cas Number:
- 85633-96-1
- Molecular formula:
- C11H10ClNO5
- IUPAC Name:
- 4-(4-chloro-3-nitrophenyl)-3-methyl-4-oxobutanoic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): GAMMANAP step 5
- Physical state:solid
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 Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks old
- Weight at study initiation:between 1.0 and 3 kg
- Housing: Indibvidually in labelled cages with perforated floors
- Diet (e.g. ad libitum):Standard labnoratory rabbit diet, approx 100 g per day
- Water (e.g. ad libitum): Free acces to tap water.
- Acclimation period:At least 5 days before start of treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):21±3 º C
- Humidity (%):30-70 %
- Air changes (per hr): ca 15
- Photoperiod (hrs dark / hrs light): 12 hopyurs artificail fluorescent ligjht/12 hours dark per day
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- instillation Iin conjunctival sac
- Controls:
- other: one eye exposed, one eye as reference
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 62.4 mg - Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- the eyes of each animal were examinated approximately 1, 24, 48 and 72 hours and 7 days after instillation of the test substance.
Mortality/Viability observed twice daily; Toxicity observed at least once daily - Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM:
TOOL USED TO ASSESS SCORE: fluorescein
Inmediately after 24 h observation a solution of 2 % fluoresein in water adjusted tpo pH 7.0 was ibnstilled in both eyes of each animal .
Each animal i treated with the substance in one fof the eyes, the other eye remained untreated and served as reference control
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean value 24-72 h
- Score:
- ca. 2.3
- Max. score:
- 2.3
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean value 24-72 h
- Score:
- ca. 1.2
- Max. score:
- 1.3
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- other: mean value 24-72 h
- Score:
- ca. 2.8
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean 24-72 h
- Score:
- ca. 1.8
- Max. score:
- 2
- Irritant / corrosive response data:
- Instillation of the test substance resuolted in effects on the cornea, iris and conjunctivae. Corneal injury was seen as opacity (maximum grade 3) and epithelial damage (maximum 25 % of the corneal area) as a result of the corneal injury, pannus (neovascularisation of the cornea) was apparent 7 days after instillation. The corneal injury persisted until termination (day 7 after instillation). Iridial irritation (grade 1 and 2) was observed and had resolved within 7 days. Irritation of the conjunctivae was seen as redness, chemossis and sdischarge, which persisted until termination. Reduced elasticity of the eyelids was noted from 48 hours after instillation until termination of study.
- Other effects:
- Colouration. No stainingof (peri) ocular tissues by the test susbtance was observed. remanents of th etest studywere present in the eyes of all animals on day 1
No symptoms of systemic toxicity were observed and no mortality occurred during the test period
Any other information on results incl. tables
TABLE 1 INDIVIDUAL EYE IRRITATION SCORES
| Cornea | iris | conjunctivae | coments | |||||||
| Time after dosing | Opacity | Area | Fluor area % | Redness | Chemosis | Discharge | ||||
Animal No 794 |
||||||||||
| 1 h | 1 | 1 | 1 | 2 | 4 | 1 | b | |||
| 24 h | 2 | 3 | 25 | 1 | 3 3 | 2 | 2 | |||
| 48 h | 2 | 3 | 1 | 3 3 | 2 | 1 | f | |||
| 72 h | 3 | 2 | 25 | 1 | 33 | 1 | 1 | f | ||
| 7 days | 2 | 2 | 0 | 0 | 1 1 | 0 | 0 | f c p | ||
| Animal No 811 | ||||||||||
| 1 h | 1 | 2 | 1 | 2 | 4 | 1 | b | |||
| 24 h | 2 | 2 | 25 | 1 | 2 | 2 | 2 | |||
| 48 h | 2 | 2 | 1 | 3 | 2 | 1 | f | |||
| 72 h | 3 | 1 | 25 | 2 | 3 | 1 | 1 | f | ||
| 7 days | 2 | 2 | 0 | 0 | 1 | 0 | 0 | f c p | ||
| Animal No 818 | ||||||||||
| 1 h | 1 | 2 | 1 | 2 | 4 | 1 | b | |||
| 24 h | 2 | 3 | 25 | 1 | 3 | 3 | 2 | |||
| 48 h | 2 | 3 | 1 | 3 | 2 | 2 | f | |||
| 72 h | 3 | 2 | 25 | 2 | 3 | 1 | 1 | f | ||
| 7 days | 2 | 3 | 0 | 0 | 1 | 0 | 0 | fcp | ||
Fluor Area (%) :green staining (percentage of total cornea area) after fluorescein treatment
Comments
b remnants of the test substance in the eyes
c Oedema of the cornea
p Pannus, neovascularism of the cornea
f reduced elasticity of the eye lids
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the degree and persistence of the corneal injury it was concluded that ocular corrosion had occured by instillation og GAMMANAP STEP 5 into the rabbit eye in all three animals used.
- Executive summary:
Instillation of the test substance resuolted in effects on the cornea, iris and conjunctivae. Corneal injury was seen as opacity (maximum grade 3) and epithelial damage (maximum 25 % of the corneal area) as a result of the corneal injury, pannus (neovascularisation of the cornea) was apparent 7 days after instillation. The corneal injury persisted until termination (day 7 after instillation). Iridial irritation (grade 1 and 2) was observed and had resolved within 7 days. Irritation of the conjunctivae was seen as redness, chemosis and discharge, which persisted until termination. Reduced elasticity of the eyelids was noted from 48 hours after instillation until termination of study.
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