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EC number: 700-578-0 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The reliability is rated 1 because the study followed the standard guideline of reference (OECD 405), which describes a procedure designed to evaluate this endpoint, the results were reviewed for reliability and assessed as valid, and the study was conducted under GLP condition.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2008
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:
- Mono and bis and tris{tris[4-(mono and dimethylamino)phenyl]methylium} [12,21,30,32-tetrahydro-29H,31Hphthalocyanine- mono, bis and trisulfonato-k4N29,N30,N31,N32]cuprate.
- IUPAC Name:
- Mono and bis and tris{tris[4-(mono and dimethylamino)phenyl]methylium} [12,21,30,32-tetrahydro-29H,31Hphthalocyanine- mono, bis and trisulfonato-k4N29,N30,N31,N32]cuprate.
- Details on test material:
- - Name of test material : Sepisol Fast Violet 2B
- Physical state/ appearance: dark violet powder
- Lot/batch No.: 423393
- Storage condition of test material: ambient temperature and in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage GRIMAUD, 49459, FRANCE
- Weight at study initiation: 2.610 kg the day of the test material application
- Housing: Singly housed, in suspended stainless steel cage (60cm x 45 cm x 32 cm)
- Diet: granules Starlap Unic Robe (EVIALIS, 37018 Tours, France)
- Water : ad libitum
- Acclimation period: 5 days at least
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 50 +/- 20
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs/1 2 hrs
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye of the animal serves as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,1 g - Duration of treatment / exposure:
- single exposure followed by contention period of one hour
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 1 animal.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No removal by washing
SCORING SYSTEM: according to OECD 405
TOOL USED TO ASSESS SCORE: macroscopic examination and examination with fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean score: 24,48 and 72h after application
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- other: Redness
- Basis:
- animal #1
- Time point:
- other: mean score: 24,48 and 72h after application
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean score: 24h, 48 and 72 h after application
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean score: 24h, 48h, 72h after application
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Irritant / corrosive response data:
- The test item leads to a non-reversible irritation
Any other information on results incl. tables
Scores
Chemosis
Chemosis score for animal 1 |
Observation period (after application) |
||||||||
1h |
24h |
48h |
72h |
Mean |
Day 5 up to 10 |
Day 11 up to 20 |
Day 18 up to 20 |
Day 21 |
|
3 |
4 |
4 |
4 |
4.0 |
4 |
3 |
2 |
1 |
|
Redness
Redness Score for Animal 1 |
Observation period (after application) |
||||||
1h |
24h |
48h |
72h |
Mean* |
Day 5 up to 21 |
||
2 |
3 |
3 |
3 |
3 |
3 |
||
Iris
Iris Score for Animal 1 |
Observation period (after application) |
||||||
1h |
24h |
48h |
72h |
Mean* |
Day 5 up to 21 |
|
|
1 |
1 |
1 |
1 |
1 |
1 |
|
|
Cornea
Cornea Score for Animal 1 |
Observation period (after application) |
||||||
1h |
24h |
48h |
72h |
Mean* |
Day 5 up to 21 |
||
0 |
2 |
2 |
2 |
2.0 |
2 |
||
* mean of observed values at 24, 48 and 72h after application
Clinical observations:
| Time Reading | Comments |
| Animal #1 | |
| Day 1 (first hour) | Nothing to report |
| Day 2 up to day 8 | Burned nictitating membrane - Opacity visible to the naked eye -Alopecia |
| Day 9 up to Day 14 | Mild burning of the nictitating membrane - Corneal opacity visible to the naked eye - Presence of a pannus and alopecia |
| Day 15 up to Day 21 | Mild burning of the nictitating membrane - Corneal opacity visible to the naked eye - Presence of a pannus and alopecia – Mild cornea edema |
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions, the test item is classified as irritant category 1 according to the CLP regulation (EC 1272/2008).
- Executive summary:
The aim of this study was to assess qualitatively and quantitatively irritancy or corrosion and the delay of appearance of the effects after
single application of 0.1 g of the pure test material named Sepisol Fast Violet 2B as supplied on eye in one rabbit. The assay was
performed according to the OEDC guideline n° 405.
Ocular reactions (redness and chemosis of conjunctivae, iris and cornea lesions) were scored 1h, 24h, 48h and 72 h after application and until the end of the period study (D21). The untreated eye served as control.
The results for the mean score were as follows (mean score 24h, 48h and 72h after application): chemosis: 4.0; redness: 3.0; Iris:1.0 and
Cornea: 2.0. In regards of the results observed and the irreversibility of the lesions at the end of the observation period on D21, the study was not carried out on 2 other rabbits for ethical reasons.
According to the criteria defined in the CLP regulation (EC 1272/2008), the test material is found to be classified as eye damage category 1.
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