Life Power® L1

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

other: fine dust

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Source: S&K-LAP Kft. 2173 Kartal, Császár út 135, Hungary
Number of animals: 3 animals.
Age of animals at treatment: ~11 weeks old (adult).
Sex: Male.
Body weight range at the beginning of the life phase: 2616 – 2763 g, end of the life phase: 2653 – 2790 g.
Acclimatization time: 5 days.

Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature during the study: 20 ± 3°C.
Relative humidity during the study: 30 – 70 %.
Housing/Enrichment: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.
Ventilation: 15-20 air exchanges/hour
Feeding: UNI diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum.
Water: Municipal tap water, as for human consumption, ad libitum.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

A single dose of 0.1 g of the solid test item was administered to each animal.

Duration of treatment / exposure:

Single dose.
The eyes of the test animals were washed out at 1 hour after application of test item.

Observation period (in vivo):

The eyes were examined at 1, 24, 48 and 72 hours after treatment.

Number of animals or in vitro replicates:

Three.

Details on study design:

An initial test was performed using one animal. The test item was instilled into the conjunctival sac of the left eye. The eyelids were held closed for a few seconds to prevent the loss of the test item. The contra lateral eye served as the control. Immediately after the administration of the test item, an assessment of the initial pain reaction was made according to a six point scale. After consideration of the ocular responses produced in the first animal, one hour after the treatment of the first animal, two additional animals were treated.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 48 and 72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1 to 72 h

Score:

0

Max. score:

0

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1 to 72 h

Score:

0

Max. score:

0

Results 6

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1 to 72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

Initial Pain Reaction (IPR) (score 1 or 2) was observed in all animals.
One hour after the application, conjunctival redness (score 1 or 2), discharge (score 1 or 2) were seen in all rabbits.
At 24 hours after treatment conjunctival redness (score 1) was seen in all rabbits.
At 48 and 72 hours after treatment, no signs of eye irritation or other clinical signs were observed.

Other effects:

MORTALITY: There was no mortality observed during the study.
BODY WEIGHTS: The body weight and body weight change were considered to be normal with no indication of a treatment related effect.
GENERAL CLINICAL OBSERVATION: There were no clinical signs observed that could be related to treatment.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The test item caused conjunctival irritant effects at one hour which were reduced at 24 hours after application. The effects were fully reversible within 48 hours.
According to Regulation (EC) No 1272/2008, the substance does not require classification as an eye irritant.

Executive summary:

An acute eye irritation study of the test item was performed in New Zealand White rabbits. The irritation effects of the test item were evaluated according to the OECD method 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 of 0.1 g of the test item was administered as a single dose.

Individual body weight was recorded at the beginning and end of the study. Morbidity and clinical signs of toxicity were checked daily. The eyes were examined at 1, 24, 48 and 72 hours after the application.

Results:

Initial Pain Reaction (IPR) (score 1 or 2) was observed in all animals.

One hour after the application, conjunctival redness (score 1 or 2), discharge (score 1 or 2) were seen in all rabbits.

At 24 hours after treatment conjunctival redness (score 1) was seen in all rabbits.

At 48 and 72 hours after treatment, no signs of eye irritation or other clinical signs were observed.

As all signs of eye irritation had fully reversed the study was terminated after a period of 72 hours observation.

No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.

According to Regulation (EC) No 1272/2008, the substance does not require classification as an eye irritant.