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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7.6.2010 - 24.6.2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was carried out in accordance with internationally valid GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
The increase of temperature (up to 23.6°C) and humidity (up to 76%). The limit for temperature in animal room is 20 ± 3°C and for humidity is 30 - 70% ± 3%. The deviation from the limit was short-term and did not influence the study results.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Reaction product of Distillates (petroleum), acid-treated heavy naphthenic and calcium oxide
- Molecular formula (if other than submission substance): not known - UVCB substance
- Molecular weight (if other than submission substance): not known - UVCB substance
- Smiles notation (if other than submission substance): not known - UVCB substance
- InChl (if other than submission substance): not known - UVCB substance
- Substance type: technical product
- Physical state: solid
- Lot/batch No.: 26.2.2010
- Expiration date of the lot/batch: 26.2.2012
- Stability under test conditions:
- Storage condition of test material: The substance was stored in PE bottle at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic, RČH CZ 21760152
- Age: 4-5 months
- Weight at study initiation: 3.1 - 3.6 kg
- Housing: Conventional animal room - individually in metallic cages
- Diet: Standard pelleted diet TM-MAK 1 for rabbits and guinea pigs ad libitum (producer: Ing.Mrkvička Miroslav - Výroba krmných směsí, Mlýn Kocanda, 252 42 Jesenice u Prahy, Czech Republic)
- Water: drinking tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: room temperature 17 - 23ºC, permanently monitored
- Humidity: 30 - 70 %, permanently monitored
- Photoperiod: 12-hour light/dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g

Duration of treatment / exposure:
24 hours

Observation period (in vivo):
1, 24, 48, 72 hours

Number of animals or in vitro replicates:
3

Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: water irrigation
- Time after start of exposure: 24 hours

SCORING SYSTEM:
The grades of ocular reaction (conjunctivae, cornea and iris) - see table bellow

TOOL USED TO ASSESS SCORE: fluorescein, ophthalmoscopy

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1, 24 hours
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 48, 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 hours
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 hours
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 48, 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 hour
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 hour
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 hours
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 48, 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1 hour
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
No corrosive response data

Other effects:
No clinical signs of systemic intoxication
No mortality



Any other information on results incl. tables

The following changes were observed on eye at 1 hour after application:

conjunctivae – diffuse, crimson colour, individual vessels not easily discernible;

chemosis – some swelling above normal in all rabbits.

The effects on conjunctivae (diffuse, crimson colour, individual vessels not easily discernible or some blood vessels hyperaemic (injected)) were observed in all animals at the 24 hours after application.

The effects on conjunctivae (lower eyelid – whitish focus) were observed in all animals from 48 hours to the 5th day. In two animals change on the conjunctivae persisted to the 6 day. On the 7th day no alterations appeared. The test substance was irrigated with water 24 hours after application. The test substance was not irrigated totally by the reason of sticking the test substance on the conjunctivae sac (lower eyelid). These remainders caused change of the conjunctivae (lower eyelid - whiting focus).

 

  

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The test substance was tested for the assessment of eye irritation/corrosion effects using albino rabbit (New Zealand Albino breed). The test was performed according to the Method B.5 Acute Toxicity: Eye Irritation/Corrosion. Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

The test was performed initially using one animal. Because a corrosive effect was not observed in initial test, the response was confirmed using two additional animals.

The following changes were observed on eye at 1 hour after application: conjunctivae - diffuse, crimson colour, individual vessels not easily discernible; chemosis – some swelling above normal in all rabbits. The effects on conjunctivae (diffuse, crimson colour, individual vessels not easily discernible or some blood vessels hyperaemic (injected)) were observed in all animals at the 24 hours after application. The effects on conjunctivae (lower eyelid - whitish focus) were observed in all animals from 48 hours to the 5th day. In two animals change on the conjunctivae persisted to the 6thday. On the 7thday no alterations appeared. The test substance was irrigated with water 24 hours after application. The test substance was not irrigated totally by the reason of sticking the test substance on the conjunctivae sac (lower eyelid). These remainders caused change of the conjunctivae (lower eyelid - whiting focus).

No clinical signs of systemic intoxication were detected.

 

Evaluation of results after single application demonstrated that the test substance is not irritating for eye of rabbit.