Nickel bis(dibutyldithiocarbamate)

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Nickel bis(dibutyldithiocarbamate)

EC Number:

237-696-2

EC Name:

Nickel bis(dibutyldithiocarbamate)

Cas Number:

13927-77-0

Molecular formula:

C18-H36-N2-Ni-S4

IUPAC Name:

Nickel(II) Dibutyldithiocarbamate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Name of the test item (as cited in study report): Nickel dibutyldithiocarbamate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

ENVIRONMENT
- Housing: The animals are caged individually and receive no hay or other extraneous material that might enter the eyes.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated eye per animal served a control

Amount / concentration applied:

100 mg of the test substance is allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material.

Duration of treatment / exposure:

single application

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

- The eyes are examined before testing and only those animals without observable eye defects were used.
- The eyes are not washed following instillation and the animals are released immediately.
- The eyes are examined at 24, 48, 72 hours and 7 days after instillation of the test material.
- Ocular reactions are read using a binocular magnifying glass.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #5

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 7 days except for animal #2

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3, #5

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days except for animal #2

Results 6

Irritation parameter:

iris score

Basis:

animal: #4, #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #4

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 days except for animal #4

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal: #2, #3, #6

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

not fully reversible within: 7 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 7 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal: #1, #5

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

chemosis score

Basis:

animal: #2, #6

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 13

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Irritating effects on the rabbit eye were reported in the key study (corneal opacity score ≥ 1 and iritis score ≥ 1). The study was limited by a reduced observation period (7 days in stead of 21 days), even though some effects were not fully reversed at day 7. Given that the supporting study shows no indication of eye irritation in rabbits, it is assumed that effects observed in the key study would have been fully reversed after 21 days after exposure. Therefore, the test substance is classified as irritating, but not corrosive.