Reaction mass of copper and iron and zinc

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 December 2005 to 15 December 2005

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:

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:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.0-3.5 kg
- Housing: Animals were individually housed in suspended cages
- Diet: free access
- Water: free access
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes 15 times per hour
- Photoperiod: 12 h darkness / 12 h light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

A volume of 0.06 ml of the test material (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye.

Observation period (in vivo):

1, 24, 48 and 72 h after the treatment

Number of animals or in vitro replicates:

3

Details on study design:

The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating t the cornea by the letters E (degree of opacity) and F (area of cornea involved). For each tissue the score was calculated as follows:

Score for conjunctivae = (A+B+C) x 2
Score of iris = D x 5
Score for cornea = (E x F) x 5

Using the numerical data obtained a modified version of the system described by Kay JH and Calandra JC (1962) was used to classify the ocular irritancy potential of the test material. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated. The highest of these group means (the maximum group mean score) together with the persistence of the reactions enabled classification of the eye irritancy potential of the test material.

If evidence of irreversible ocular damage is noted, the test material will be classified as corrosive to the eye.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Remarks:

Individual Total Scores

Basis:

animal #1

Time point:

other: 1 h

Score:

4

Max. score:

110

Reversibility:

fully reversible within: 24h

Results 2

Irritation parameter:

overall irritation score

Remarks:

Individual Total Scores

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

110

Results 3

Irritation parameter:

overall irritation score

Remarks:

Individual Total Scores

Basis:

animal #2

Time point:

other: 1, 24, 48 and 72 h

Score:

0

Max. score:

110

Results 4

Irritation parameter:

overall irritation score

Remarks:

Individual Total Scores

Basis:

animal #3

Time point:

other: 1, 24, 48 and 72 h

Score:

0

Max. score:

110

Irritant / corrosive response data:

No corneal or iridial effects were noted during the study.

No evidence of ocular irritation was noted in two treated eyes throughout the study or in the remaining treated eye at the 24-hour observation.

Any other information on results incl. tables

Individual scores and individual total scores for ocular irritation

Rabbit Number and Sex	23 Male				90 Male				92 Male
	IPR=2				IPR=2				IPR=2
Time After Treatment	1 Hour	24 Hours	48 Hours	72 Hours	1 Hour	24 Hours	48 Hours	72 Hours	1 Hour	24 Hours	48 Hours	72 Hours
CORNEA E = Degree of Opacity F= Area of Cornea Involved	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
Score (E x F) x 5	0	0	0	0	0	0	0	0	0	0	0	0
IRIS D	0	0	0	0	0	0	0	0	0	0	0	0
Score (D x 5)	0	0	0	0	0	0	0	0	0	0	0	0
CONJUNCTIVAE A = Redness B= Chemosis C= Discharge	1 0 1	0 0 0	0 0 0	0 0 0	0 0 0sf	0 0 0	0 0 0	0 0 0	0 0 0sf	0 0 0	0 0 0	0 0 0
Score (A+ B + C) x 2	4	0	0	0	0	0	0	0	0	0	0	0
Total Score	4	0	0	0	0	0	0	0	0	0	0	0

IPR=Initial pain reaction

SF=Black staining of the fur around the treated eye

Individual total scores and group mean scores for ocular irritation

Rabbit Numer and Sex	Individual Total Scores At:
	1 Hour	24 Hours	48 Hours	72 Hours
23 Male	4	0	0	0
90 Male	0	0	0	0
92 Male	0	0	0	0
Group Total	4	0	0	0
Group Mean Score	1.3	0.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material produced a maximum group mean score of 1.3 and was classified as practically non-irritant (class 2 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

Executive summary:

The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the Guideline OECD 405 and Method B5.

 

A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. No evidence of ocular irritation was noted in two treated eyes throughout the study or in the remaining treated eye at the 24 -hour observation.

 

The test material produced a maximum group mean score of 1.3 and was classified as practically non-irritant (class 2 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.