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Registration Dossier
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EC number: 440-860-8 | CAS number: 85633-96-1
Endpoint summary
Administrative data
Description of key information
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.
Key value for chemical safety assessment
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- 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 - 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 - 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 - 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Only available study
Effects on eye irritation: irritating
Justification for classification or non-classification
Based on the results of the study substance is classified according to EC criteria
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