Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with Good laboratory Practice and internationally accepted guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
calcium tetracopper(2+) dioxocopperbis(olate) hexahydroxide sulfate
EC Number:
910-853-9
Cas Number:
8011-63-0
Molecular formula:
Ca3Cu4H6O22S4.nH2O where n = 1 to 6
IUPAC Name:
calcium tetracopper(2+) dioxocopperbis(olate) hexahydroxide sulfate
Details on test material:
- Name of test material (as cited in study report): Bordeaux Mixture
- Composition of test material, percentage of components: Not stated.
- Lot/batch No.: 3/0371

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three young adult male New Zealand white rabbits weighing 2.1 to 2.4 kg were housed individually and acclimatised prior to dosing.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 grams.
Duration of treatment / exposure:
Refer to details on study design.
Observation period (in vivo):
21 days.
Number of animals or in vitro replicates:
Three.
Details on study design:
0.1 g of the test substance was administered into the conjunctival sac of the right eye of each rabbit and the eyelids held together for one or two seconds before release. Animals were examined for signs of eye irritation after 1, 24, 48 and 72 hours and up to 21 days after administration, and irritation scored according to Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
2.1
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 5 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 5 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritant / corrosive response data:
Bordeaux Mixture caused corneal opacity (up to score 4), iris lesion (up to score 1), conjunctival redness (up to score 2) and conjunctival chemosis (up to score 3) of the eyes in all animals at one or more assessment times. Cornea opacity persisted up to the end of the study (21 days after administration) in one animal.
Other effects:
Records of non relevant endpoints for classification such as the area of the cornea affected and conjunctival discharge were also made in the study but these are not presented in this summary, as they are not relevant to the outcome.

Any other information on results incl. tables

Table 1. Summary of individual and mean eye irritation scores according to Draize

Assessment time

Scores according to Draize for animal number

Cornea opacity

Iris lesion

Conjunctival redness

Conjunctival chemosis

401

402

403

401

402

403

401

402

403

401

402

403

1 hour

0

0

0

1

1

1

1

1

1

0

0

0

24 hours

1

2

4

1

1

-c

2

1

2

1

1

3

48 hours

1

2

4

1

1

1

1

1

1

1

1

1

72 hours

1

2

-b

1

1

-b

1

1

-b

0

1

-b

4 days

-

1

-

-

1

-

-

1

-

-

0

-

5 days

1

1

-

0

0

-

0

0

-

0

0

-

6 days

1

1

-

0

0

-

0

0

-

0

0

-

7 days

1

1

-

0

0

-

0

0

-

0

0

-

8 days

1

-

-

0

-

-

0

-

-

0

-

-

10 days

-

1

-

-

0

-

-

0

-

-

0

-

11 days

1

-

-

0

-

-

0

-

-

0

-

-

14 days

-

1

-

-

0

-

-

0

-

-

0

-

15 days

0

-

-

0

-

-

0

-

-

0

-

-

17 days

-

1

-

-

0

-

-

0

-

-

0

-

21 days

-

1

-

-

0

-

-

0

-

-

0

-

Mean score per animala

1.0

2.0

4.0

1.0

1.0

1.0

1.3

1.0

1.5

0.7

1.0

2.0

Mean scorea
for three animals

2.1

1.0

1.3

1.3

a   Mean scores after 24, 48 and 72 hours (shaded).

b   Animal sacrificed prior to 72 hour assessment.

c   Assessment obscured (by corneal opacity).

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Ocular lesions were severe as corneal opacity persisted until the end of the study.
Classification according to Directive 67/548/EEC: Irritant (Xi). R41, Risk of serious damage to eyes.
Classification according to CLP/GHS: Eye Damage 1, H318: Causes serious eye damage.
Executive summary:

A GLP-compliant study was conducted in accordance with the requirements of EU Method B.5 and OECD 405 without significant deviation. Three young adult male New Zealand white rabbits weighing 2.1 to 2.4 kg were housed individually and acclimatised prior to dosing. 0.1 g of Bordeaux Mixture was administered into the conjunctival sac of the right eye of each rabbit and the eyelids held together for one or two seconds before release. Animals were examined for signs of eye irritation after 1, 24, 48 and 72 hours and up to 21 days after administration, and irritation scored according to Draize. Records of non relevant endpoints for classification such as the area of the cornea affected and conjunctival discharge were also made in the study but these are not presented in this summary, as they are not relevant to the outcome.

Bordeaux Mixture caused corneal opacity (up to score 4), iris lesion (up to score 1), conjunctival redness (up to score 2) and conjunctival chemosis (up to score 3) of the eyes in all animals at one or more assessment times. Cornea opacity persisted up to the end of the study (21 days after administration) in one animal. On this basis, Bordeaux Mixture is classified as Eye Damage Category 1, H318: Causes serious eye damage.