[No public or meaningful name is available]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-11-20 to 2007-11-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

August 1998

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

2004

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

April 2002

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

477-470-2

EC Name:

-

Molecular formula:

UVCB substance

IUPAC Name:

Reaction product of tetraethylsilicate, ethylpolysilicate, dioctyltinoxide, methanol and benzoic acid

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

New Zealand White Hsd If:NZW

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Age at study initiation: not specified
- Weight at study initiation: 2.6 - 2.7 kg
- Housing: ABS-plastic rabbit cages, floor 4200 cm2
- Diet (ad libitum): Altromin 2123 maintanenance diet for rabbits, specific pathogen-free
- Water (ad libitum): tap water
- Acclimation period: at least 5 days
- Microbiological status: SPF

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

not applicable, no washing;
lids were gently hold together for 1 sec

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: according to Draize (1944)

Endpoint Description Range
Cornea degree opacity and ulcerations 0–4
Iris swelling, hyperaemia 0–2
Conjunctivae redness, vessel discernibility 0–3
Chemosis swelling, lids closed/open 0–4

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 h

Remarks on result:

probability of mild irritation

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

probability of weak irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

probability of weak irritation

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

probability of weak irritation

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Animal No. 1 showed redness (grade 1), discharge (grade 2) as well as chemosis of the conjuctivae (grade 1) 1 h after instillation of the test item. 24 h post-treatment redness and chemosis (grade 1) were observed. After 48 h, redness (grade 1) was observed. After 72 h, no symptoms were obseved. Thus, the changes were fully reversible within 72 hours post instillation.

Animals No. 2 and 3 showed redness (grade 1) as well as chemosis of the conjuctivae (grade 1) 1 h after instillation of the test item. 24 h post-treatment redness (grade 1) was observed. After 48 h, no symptoms were obseved. Thus, the changes were fully reversible within 48 hours post instillation.

The scores were (conjuctivae, chemosis, cornea opacitiy, iris):
Animal 1: (0.67; 0.33; 0; 0)
Animal 2: (0.33; 0 ;0; 0)
Animal 3: (0.33; 0 ;0; 0)

Other effects:

There were no significant body weight changes during the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Considering the reported data of this irritation study, it can be stated that the test item produced slightly irritating, but no corrosive effects in the eyes of rabbits. All signs of irritation were fully reversible.

Executive summary:

The skin irritation potential of the test item was assayed in an in vivo eye irritation study according to OECD 405 in three female New Zealand White rabbits (HsdIf:NZW). 0.1 mL of the test item was instilled in the lower conjuctival sac of one eye of each animal, the untreated contralateral eye served as control. The animals were observed for 72 h for ocular lesions in the cornea, iris and conjuctivae.

Observations were scored and compared to the control eyes 1, 24, 48 and 72 h post-dose. The test item showed slightly irritant, but no corrosive effects on the eyesof 3 rabbits.

Animal No. 1 showed redness (grade 1), discharge (grade 2) as well as chemosis of the conjuctivae (grade 1) 1 h after instillation of the test item. 24 h post-treatment redness and chemosis (grade 1) were observed. After 48 h, redness (grade 1) was observed. After 72 h, no symptoms were obseved. Thus, the changes were fully reversible within 72 hours post instillation.

Animals No. 2 and 3 showed redness (grade 1) as well as chemosis of the conjuctivae (grade 1) 1 h after instillation of the test item. 24 h post-treatment redness (grade 1) was observed. After 48 h, no symptoms were obseved. Thus, the changes were fully reversible within 48 hours post instillation.

The scores were (conjuctivae, chemosis, cornea opacitiy, iris): (0.67; 0.33; 0; 0) for animal 1, (0.33; 0 ;0; 0) for animal 2 and (0.33; 0 ;0; 0) for animal 3.

There were no significant body weight changes during the observation period. Further, no corneal lesions were found in any animal at the final reading.

The test item was concluded to be slightly irritant to the eye, with full reversibility.