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Toxicological information

Eye irritation

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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

Constituent 1
Chemical structure
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:
tetrakis(diethyldithiocarbamato-S,S')tellurium
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

Resultsopen allclose all
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
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
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
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: unrinsed eyes
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
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
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
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