Tetrakis(diethyldithiocarbamato-S,S')tellurium

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:

1986

Report date:

1986

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:

Tetrakis(diethyldithiocarbamato-S,S')tellurium

EC Number:

244-121-9

EC Name:

Tetrakis(diethyldithiocarbamato-S,S')tellurium

Cas Number:

20941-65-5

Molecular formula:

C20H40N4S8Te

IUPAC Name:

N2,N2,N6,N6,N6,N6,N9,N9-octaethyl-1λ³,3,5λ³,5λ³,7,7,8λ³,10-octathia-4λ⁸-telluradispiro[3.3⁴.3⁴.3⁴]trideca-1,5,5,8-tetraene-2,6,6,9-tetramine

Test material form:

solid

Specific details on test material used for the study:

- Name of the test item (as cited in study report): Tellurium diethyldithiocarbamate
- Batch No.: MT-5D 494
- Appearance: Yellow, powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Morton Commercial Rabbits, Stansted, Essex, England.
- Weight at study initiation: 2.1-2.7 kg
- Age at study initiation: 9-12 weeks
- Housing: The rabbits were individually housed in metal cages with perforated floors.
- Diet: SDS, Standard Rabbit Diet (ad libitum)
- Water: tap water (ad libitum)

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The contralateral eye remained untreated and served as a control

Amount / concentration applied:

60 mg

Duration of treatment / exposure:

In three animals, the test substance was rinsed after 20-30 seconds. In the other six animals, the eyes remained unrinsed.

Observation period (in vivo):

1 hour and 1, 2, 3, 4 and 7 days after instillation.

Number of animals or in vitro replicates:

9 animals (1 male, 8 females)

Details on study design:

Both eyes of each animal were examined 24 hours prior to instillation of the test substance using fluorescein stain to ensure that there was no pre-existing corneal damage or conjuctival inflammation. Just prior to instillation of the test substance, the eyes were examined without using fluorescein stain. A 60 mg amount of tellurium diethyildithiocarbamate (0.1 mL in volume) was placed into the lower everted lid of one eye of each animal. 1 hour and 1, 2, 3, 4 and 7 days after instillation, the animals were examined. Observation of the eyes was aided by the use of a handheld torch. Fluorescein stain was used to detect and evaluate corneal damage from one day after instillation. Grading and scoring of the ocular lesions were performed according to Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 96 hours

Remarks on result:

other: unrinsed eyes

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: #2, #3, #4, #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: unrinsed eyes

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: unrinsed eyes

Results 4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: unrinsed eyes

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other: unrinsed eyes

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: unrinsed eyes

Results 7

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: unrinsed eyes

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: unrinsed eyes

Irritant / corrosive response data:

In animals with eyes rinsed after 20-30 seconds no corneal damage or iridial inflammation was observed. Mild conjunctival inflammation was seen in all three animals at the one hour reading only.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met