Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Six New Zealand White albino rabbits are used for each test substance. The animals are caged individually and receive no hay or other extraneous material that might enter the eyes. 100 milligrams 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. The other eye, remaining untreated, serves as a control. 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.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Zinc bis(N-ethyl-N-phenyldithiocarbamate)
EC Number:
238-677-1
EC Name:
Zinc bis(N-ethyl-N-phenyldithiocarbamate)
Cas Number:
14634-93-6
Molecular formula:
C18H20N2S4Zn
IUPAC Name:
zinc bis(N-ethyl-N-phenyldithiocarbamate)
Specific details on test material used for the study:
WTR 44 = Vulkacit P = CAS no. 14634-93-6
White powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Six New Zealand White albino rabbits are used for each test substance. 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:
not required
Amount / concentration applied:
100 milligram
Duration of treatment / exposure:
7 days (the eyes are not washed following instillation).
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 animals
Details on study design:
100 milligrams 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. The other eye, remaining untreated, serves as a control. 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.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.39
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: after 7 days 2 rabbits had a score = 1
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Iris score was 0 (24,48, 72 hours). The cornea score was 0.11 (24, 48, 72 hours), the conjunctivae score was 1.39 (24,48, 72 hours) and the chemosis score was 0.66 (24, 48 and 72 hours). The cornea score and the chemosis score were fully reversible within 72 hours. the conjunctivae score was 1 after 7 days in 2 out of 6 animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The iris score was 0 (24, 48, 72 hours). The cornea score was 0.11 (24, 48, 72 hours), the conjunctivae score was 1.39 (24, 48, 72 hours) and the chemosis score was 0.66 (24, 48 and 72 hours). The cornea score and the chemosis score were fully reversible within 72 hours. The conjunctivae score was 1 after 7 days in 2 out of 6 animals.
Executive summary:

Six New Zealand White albino rabbits are used for each test substance. The animals are caged individually and receive no hay or other extraneous material that might enter the eyes. 100 milligrams 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. The other eye, remaining untreated, serves as a control. 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.

The iris score was 0 (24, 48, 72 hours). The corne score was 0.11 (24, 48, 72 hours), the conjunctivae score was 1.39 (24, 48, 72 hours) and the chemosis score was 0.66 (24, 48 and 72 hours). The cornea score and the chemosis score were fully reversible within 72 hours. The conjunctivae score was 1 after 7 days in 2 out of 6 animals.