[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:

27 September 2006 to 1 December 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

-

EC Number:

482-480-5

EC Name:

-

Cas Number:

1187571-02-3

Molecular formula:

(R2C5H4NO2)(0-3)(R3C3H5O3)(0-3)H(0-2)B

IUPAC Name:

Coconut oil reaction products with boric acid and diethanolamine

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Test animals
Number of animals per test: 3 (Animals of both sexes were used)
Age at treatment: 16-17 weeks (male); 12-15 weeks (females)
Identification: By unique cage number and corresponding ear number.
Acclimatization: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

Environmental conditions
Air-conditioned with ranges for room temperature 17-23 °C, relative humidity 30-70 % and approximately 10-15 air changes per hour. Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room cleaning. These transient variations are considered not to have any influence on the study. The animals were provided with an automatically controlled light cycle of 12 hours light and 12 hours dark. Music was played during the daytime light period.

Accommodation: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks were provided for gnawing.

Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance
diet ad libitum.

Water Community tap water from Füllinsdorf, ad libitum.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL (per animal) of the test substance was measured with a syringe and applied undiluted as it
was delivered by the Sponsor.

Observation period (in vivo):

The eyes of each animal were examined approximately 1, 24, 48, 72 hours , as well as 7
days after administration.

Number of animals or in vitro replicates:

As it was suspected that the test item might produce irritancy, a single animal (one female)
was treated first. As neither a corrosive effect nor a severe irritant effect was observed after
the 1- and 24-hour examinations, the test was completed using the two remaining animals.

Details on study design:

On the day of treatment, 0.1 mL of of the test substance was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then
gently held together for about one second to prevent loss of test item. The right eye
remained untreated and served as the reference control. The treated eyes were not rinsed
after instillation.

No necropsy was performed on the animals sacrificed at termination of observation.
The animals were killed by intravenous injection of pentobarbitone into the ear vein at a dose
of at least 1 mL/kg body weight and discarded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Other effects:

No staining of the treated eyes produced by the test item was observed.

The body weights of all rabbits were considered to be within the normal range of variability.

Any other information on results incl. tables

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00, 0.33 and 0.33 for reddening and 0.00 for chemosis for all the animals.

No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals.

Slight reddening of the conjunctivae was noted in all animals at the 1-hour reading and persisted in two animals until 24 hours after application.

Slight swelling (chemosis) of the conjunctivae was observed in all animals at the 1-hour reading.

Slight reddening of the sclerae was present at 1 hour after treatment in all animals.

One animal showed a slight ocular discharge at the 1-hour reading.

No abnormal findings were observed in the treated eye of any animal 48 hours after treatment.

 

No corrosion of the cornea was observed at any of the reading times.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an OECD 405 study the test substance is considered to be “not irritating” to the rabbit eye.

Executive summary:

The primary eye irritation potential of the test substance was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 mL into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 days after test item instillation.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00, 0.33 and 0.33 for reddening and 0.00 for chemosis for all the animals.

 

The instillation of the test substance into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, chemosis and discharge. These effects were reversible and were no longer evident 48 hours after treatment. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the rabbit eye. 

 

Based upon the referred classification criteria (Commission Directive 2001/59/EC of 
August 06, 2001), the test substance is considered to be “not irritating” to the rabbit eye.