Registration Dossier

Administrative data

Description of key information

For that endpoint, two reliable studies to assess skin irritation and corrosion in vivo and eye irritation in vivo on the registered substance were available. These studies were performed according to the OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and OECD Guideline 405 (Acute Eye Irritation / Corrosion).

Regarding skin irritation/corrosion, under the experimental conditions, no skin reaction was observed with "Zinc cyanide batch n°10185145 " exposure. Therefore, "Zinc cyanide batch n°10185145" induced no dermal irritaiton in male New Zealand White rabbits and was considered to be a non-irritant.

Concerning eye irritation, under the experimental conditions, the Index of Acute Ocular Irritation (IAOA) of Zinc cyanide batch n°10185145 was calculated to be "4.7". Therefore, Zinc cyanide batch n°10185145 is not classified as eye irritant based on GHS criteria.

The validity criteria were successful and the study was therefore regarded as acceptable for that endpoint.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
ENVIRONMENTAL CONDITIONS: the animal room environment was automatically controlled according to KIT SOPs(target range: temperature 20±3°C, relative humidity 30-70%, approximatly 12 hours light/ 12 hours dark cycle with 150-300 Lux, and ventilation 10-20 times/hour). Temperature and relative humidity were monitored continuously. Animal room and cage cleaning was performed according to KIT SOPs. Cage card and animal room use record were attached on the cage and the entrance of the animal room, respectively.
Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
not specified
Amount / concentration applied:
0.5g
Observation period:
1, 24, 48 and 72 hours
Number of animals:
3
Irritation parameter:
erythema score
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No dermal irritation was observed at 1, 24, 48, 72 hours after test item application
Other effects:
Test item-related death or abnormal general clinical signs were not observed during the study period.
Test item-related body weight changes were not observed.
Interpretation of results:
GHS criteria not met
Conclusions:
To investigate dermal irritation of the test item, Zinc cyanide was administered by dermal at dose of 0.5 g/head for 4 hours in 3 male New Zealand White rabbits. Mortality, clinical signs, body weight change and local irritation were observed until 72 hours after test item. No clinical sign, body weight, dead animaln or abnormal skin reaction considered to be due to test item were observed. In conclusion Zinc cyanide induced no dermal irritaiton in male New Zealand White rabbits and was considered to be a non-irritant.
Executive summary:

For that endpoint, one reliable study to assess skin irritation and corrosion in vivo on the registered substance on New Zealand White rabbits was available. The study was performed according to the OECD Guideline 404 (Acute Dermal Irritation / Corrosion).

Under the experimental conditions, no skin reaction was observed with "Zinc cyanide batch n°10185145 " exposure. Therefore, "Zinc cyanide batch n°10185145" induced no dermal irritaiton in male New Zealand White rabbits and was considered to be a non-irritant.

The validity criteria were successful and the study was therefore regarded as acceptable for that endpoint.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
other: Yac:NZW(KBL)
Details on test animals or tissues and environmental conditions:
The animal room environment was automatically controlled according to KIT SOPs (target range: temperature 20+/- 3°C, relative humidity 30-70%, approximately 12 hours light/12 hours dark cycle with 150-300 Lux, and ventilation 10-20 times/hour). Temperature and relative humidity were monitored continuously. Animal room and cage cleaning was performed according to KIT SOPs.
Vehicle:
not specified
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
Not specified (1 application)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
To evaluate the eye irritation/corrosion of Zinc cyanide, 0.1g of the test item was applied in 3 healthy male New Zealand white rabbits. Mortality, clinical signs, body weight changes and eye response were measured during 72 hours after application.
Irritation parameter:
other: mean index of ocular irritation
Time point:
24/48/72 h
Score:
1.85
Max. score:
4.7
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Irritant / corrosive response data:
As a result of observation the application site until 72 hours after application of the test item, no abnormalities were observed in the cornea and iris of all animals. As a result of observation for redness, chemosis and discharge in the conjunctivia, slight redness, chemosis and discharge were observed due to the test item application.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on these results, the Index of Acute Ocular Irritation (IAOA) of the test item was calculated to be "4.7". According to the classification method for eye irritants, the test item was considered to be a minimal irritant.
Executive summary:

For that endpoint, one reliable study to assess eye irritation in vivo on the registered substance on rabbits was available. The study was performed according to the OECD Guideline 405 (Acute Eye Irritation / Corrosion).

Under the experimental conditions, the Index of Acute Ocular Irritation (IAOA) of Zinc cyanide batch n°10185145 was was calculated to be "4.7". Therefore, Zinc cyanide batch n°10185145 is not classified as eye irritant based on GHS criteria.

The validity criteria were successful and the study was therefore regarded as acceptable for that endpoint.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification