reaction mass of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-2H -isothiazol-3-one

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Remarks:

The study is considered acceptable since the conclusions highlight the corrosive status of the CMIT/MIT a.i. without any doubt. The missing details of the M&M section of the study protocol do not preclude of a wrong eye irritation assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: study was conducted prior to the implementation of Good Laboratory Practice and OECD Guidelines; however, the study was conducted in accordance with acceptable and generally recognized scientific practices at the time it was conducted.

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Test material form:

other: Amber liquid

Details on test material:

- Name of test material (as cited in study report): Kathon™ 886 all magnesium formulation
- Physical state: Amber liquid
- Stability under test conditions: stable at room temperature

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Rohm and Haas, Batch No. 0098

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Stable at room temperature
- Solubility and stability of the test substance in the solvent/vehicle: Soluble and stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: No
- Final dilution of a dissolved solid, stock liquid or gel: Undiluted

OTHER SPECIFICS: Purity of test material was 13.2% a.i.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Not described in report
- Age at study initiation: Not described in report
- Weight at study initiation: Not described in report

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 13.2 % active ingredient

Duration of treatment / exposure:

Not described in report

Observation period (in vivo):

Postexposure period: 7 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not described
- Time after start of exposure: Not described

SCORING SYSTEM: Not described

TOOL USED TO ASSESS SCORE: Not described

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 hours

Score:

36.7

Reversibility:

not reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 72 hours

Score:

30

Reversibility:

not reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 7 days

Score:

68

Reversibility:

not reversible

Results 4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 hours

Score:

5

Reversibility:

not reversible

Results 5

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 72 hours

Score:

10

Reversibility:

not reversible

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 hours

Score:

20

Reversibility:

not reversible

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72 hours

Score:

20

Reversibility:

not reversible

Results 8

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 7 days

Score:

20

Reversibility:

not reversible

Irritant / corrosive response data:

Kathon™ 886 is corrosive to the intact skin of rabbits. The skin effects at 14 days are indicative of irreversible damage to the skin. Kathon™ 886 produces severe lesion to the eyes of rabbit which were not reversible.

Other effects:

- Lesions and clinical observations: In some instances the reaction upon the iris could not be evaluated properly because of the severe swelling of the eyelids

Any other information on results incl. tables

Results of eye irritation study

	Cornea	Iris	Conjunctiva
Score (average of animals investigated)	6 rabbits	6 rabbits	6 rabbits
24 h	36.7	5.0	20.0
48 h	30.0	10.0	20.0
7 days	68.0	--	20.0
Reversibility^*	n	n	n
Average time for reversion	NA	NA	NA
* c : completely reversible; n c : not completely reversible; n : not reversible.
Method for score calculation not described in report.  NA = not applicable  -- = In some instances the reaction upon the iris could not be evaluated properly because of the severe swelling of the eyelids.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Kathon™ 886 is corrosive to the intact skin of rabbits. The skin effects at 14 days are indicative of irreversible damage to the skin. Kathon™ 886 produces severe lesion to the eyes of rabbit which were not reversible. Kathon™ 886 should be considered as corrosive to the eyes of rabbits.

Executive summary:

The in-life portion of this study was conducted prior to the implementation of Good Laboratory Practice and OECD Guidelines; however, the study was conducted in accordance with acceptable and generally recognized scientific practice at the time it was conducted.

Kathon™ 886 is corrosive to the intact skin of rabbits. The skin effects at 14 days are indicative of irreversible damage to the skin. Kathon™ 886 produces severe lesion to the eyes of rabbit which were not reversible. Kathon™ 886 should be considered as corrosive to the eyes of rabbits.