Ziram

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 Mar - 13 Mar 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Version / remarks:

adopted in 1984

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

not specified

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ziram

EC Number:

205-288-3

EC Name:

Ziram

Cas Number:

137-30-4

Molecular formula:

C6H12N2S4Zn

IUPAC Name:

ziram

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: A. Smith, Surrey, UK
- Age at study initiation: approximately 12 weeks
- Weight at study initiation: 2.686 kg
- Housing: Animals were individually housed in metal cages with perforated floors.
- Diet: SDS standard rabbits diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: rabbit was acclimated to the laboratory environment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19
- Humidity (%): 30 - 70
- Air changes (per hr): approximately 19
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 80 mg of the test substance accupying a volume of 0.1 mL

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

24 h

Number of animals or in vitro replicates:

1 (due to severity of effects)

Details on study design:

REMOVAL OF TEST SUBSTANCE
Test substance was not removed.

SCORING SYSTEM: Draize criteria as stated in OECD guideline 405

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: The animal was sacrificed 24 h after instillation on humane grounds.

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Remarks on result:

other: The animal was sacrificed 24 h after instillation on humane grounds. Necrosis and partial destruction of nictitating membrane was observed.

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks on result:

other: The animal was sacrificed 24 h after instillation on humane grounds.

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: The animal was sacrificed 24 h after instillation on humane grounds.

Irritant / corrosive response data:

An opacity covering the entire corneal surface was present 24 h after instillation. Iridial inflammation had developed by the 24-h reading. A diffuse beefy-red colouration of the conjunctivae accompanied by considerable swelling with the eyelids more than half-closed and a copious discharge were observed 24 h following instillation. Necrosis and partial destruction of the nictitating membrane were also present. Due to the severity of the response, only one animal was exposed to the test substance and the study was terminated due to animal welfare reasons 24 h after instillation.

Other effects:

There was no indication of a systemic effect of treatment.

Applicant's summary and conclusion

Interpretation of results:

other: According to the classification criteria of the CLP Regulation (EU) No. 1272/2008, classification for eye damage Category 1 (H318) is warranted.

Conclusions:

The study is in accordance with EPA OPP 81-4 (Acute Eye Irritation) and GLP. The eye irritation potential of the test substance was investigated in New Zealand White rabbits by placing approximately 80 mg (0.1 mL) of the test substance into the lower everted lid of one eye. Under the conditions chosen, instillation of the test substance into the rabbit eye elicited a positive response. Severe eye damage was observed with eye irritation scores of 3, 2, 3 and 4 for cornea, iris, redness and chemosis, respectively. Due to the severity of the response, only one animal was exposed to the test substance and the study was terminated due to animal welfare reasons 24 h after instillation. According to the classification criteria of the CLP Regulation (EU) No. 1272/2008, classification for eye damage Category 1 (H318) is warranted.