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EC number: - | CAS number: -
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- Irritation / corrosion
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![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 to 11 June 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to OECD 405 and GLP guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- Name: Reddish Blue
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: S&K-LAP Kft. 2173 Kartal, Császár út 135, Hungary
- Age at study initiation: 11 to 12 weeks
- Weight at study initiation: 3247 to 3415 g
- Housing: single
- Diet: PURINA Base – Lap gr. diet for rabbits ad libitum
- Water: tap water ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.0 to 23.0
- Humidity (%): 30 to 70
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 28 September to 1 October 2009
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline solution
- Time after start of exposure: 1 hour
SCORING SYSTEM:
1, 24, 48, and 72 hours, then at 1 week post treatment
1. Conjunctivae
A. Redness (Palpebral and bulbar)
Normal 0
Some blood vessels hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3
B. Chemosis
Normal 0
Some swelling above normal (includes nictating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4
C. Discharge
No discharge 0
Any amount different from normal (does not include small amounts
observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs, on considerable area
around the eye 3
2. Iris
D. Values
Normal 0
Markedly deepened rugae, congestion, swelling, moderate
circumcorneal hyperaemia: or injection: iris reactive to light
(a sluggish reaction is considered to be an effect) 1
Haemorrhage, gross destruction, or no reaction to light. 2
3. Cornea
E. Opacity-degree of density (Area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight
dulling of normal lustre): details of iris clearly visible 1
Easily discernible translucent area: details of iris slightly obscured 2
Nacrous area: no details of iris visible: size of pupil barely discernible 3
Opaque cornea: iris not discernible through the opacity 4
F. Area of cornea involved
One quarter (or less), but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4
Irreversible effects on the eye/serious damage to eyes (Category 1)
If, when applied to the eye of an animal, a substance produces:
— at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days;
and/or
— at least in 2 of 3 tested animals, a positive response of:
o corneal opacity ≥ 3 and/or
o iritis > 1,5
calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.
Reversible effects on the eye/irritating to eyes (Category 2)
If, when applied to the eye of an animal, a substance produces:
— at least in 2 of 3 tested animals, a positive response of:
o corneal opacity ≥ 1 and/or
o iritis ≥ 1, and/or
o conjunctival redness ≥ 2 and/or
o conjunctival oedema (chemosis) ≥ 2
o calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 1, 2, 3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 1, 2, 3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 1, 2, 3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33 - 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: redness
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 1, 2, 3
- Time point:
- other: 24 to 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No abnormalities were detected in the control eyes during the entire study period.
Initial Pain reaction (score 1) was observed in all animals. All animals blinked several times in response to instillation of the test item.
One hour after the application, conjunctival redness (score 2) was observed in two animals, conjunctival redness (score 1) in one animal, discharge (score 2) was found in two animals, and discharge (score 1) in case of one animal.
At 24 hours after treatment, conjunctival redness (score 2) was observed in two animals, conjunctival redness (score 1) in one animal.
At 48 hours after treatment, conjunctival redness (score 1) was found in two animals.
At 72 hours after treatment, there were no signs of eye irritancy observed.
Any other information on results incl. tables
INDIVIDUAL SCORES FOR OCULAR IRRITATION
Time |
Animal No. |
Score of irritation |
IPR |
|||||||
Conjunctivae |
Opacity of cornea |
Iris |
Control eye |
Other sign |
||||||
R |
CH |
D |
OD |
OE |
R |
|||||
1 hour |
00565 |
2 |
0 |
1 |
0 |
0 |
0 |
0 |
- |
2 |
00566 |
2 |
0 |
2 |
0 |
0 |
0 |
0 |
- |
2 |
|
00564 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
- |
2 |
|
24 hours |
00565 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
00566 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
||
00564 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
||
48 hours |
00565 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
00566 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
||
00564 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
||
72 hours |
00565 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
00566 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
||
00564 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
R = Redness; OD = Opacity degree of density; CH = Chemosis; OE = Extension of opaque area; D = Discharge; IPR = Initial pain reaction; - = No clinical signs
BODY WEIGHT DATA
Animal Number |
Beginning of study |
At the end of study |
Body weight gain |
00565 |
3415 |
3487 |
72 |
00566 |
3255 |
3311 |
56 |
00564 |
3247 |
3305 |
58 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, according to Regulation (EC) No 1272/2008, Reddish Blue does not require classification as an eye irritant.
- Executive summary:
An acute eye irritation study of the test item Reddish Blue was performed in New Zealand White rabbits. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 405, 2002).
The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. An amount ofof the solid test item was administered as a single dose. The eyes of the test animals were rinsed with 0.9% NaCl solution, one hour after application of the test item.
The eyes were examined at 1, 24, 48 and 72 hours after the application.
Initial Pain Reaction (score 2) was observed in all animals. Rabbits blinked and tried to open the eye, but reflex closed it in response to instillation of the test item.
One hour after the application, conjunctival redness (score 2) was observed in two animals and conjunctival redness (score 1) in one animal. Conjunctival discharge (score 1) was found in two animals and discharge (score 2) in one rabbit.
At 24 hours after treatment, conjunctival redness (score 1) was observed in all animals.
At 48 hours after treatment, conjunctival redness (score 1) was observed in one animal.
At 72 hours after treatment, there were no signs of eye irritation observed.
As there were no local or systemic clinical signs observed 72 hours after test item administration, the study was terminated after the 72-hour observation.
No abnormalities were detected in the control eyes during the entire study period.
The general state and behaviour of animals were normal throughout the study period. There were no notable body weight changes during the study period.
The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:
Animal Number
Cornea Opacity
Iris
Conjunctivae
Redness
Chemosis
Discharge
00565
0.00
0.00
0.67
0.00
0.00
00566
0.00
0.00
0.33
0.00
0.00
00564
0.00
0.00
0.33
0.00
0.00
The test item Reddish Blue, applied to the rabbits eye mucosa, caused significant conjunctival irritant effects at one hour which were reduced 24 hours after application. The effects were fully reversible within 72 hours.
According to Regulation (EC) No 1272/2008, Reddish Blue does not require classification as an eye irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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