Registration Dossier

Administrative data

Description of key information

The substance sodium cyanate revealed only minimal skin irritating effects in rabbits (edema score 0.22, erythema score 0).
The substance Sodium cyanate revealed only very weak irritating effects to rabbit´s eye (cornea score 0.22, iris score 0.22, conjunctivae score 1.11, chemosis score 0) wich were reversible within at least 3 days.
Based on experience in handling and use sodium cyanate is not irritating to the respiratory system.

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:
1984-08-15 to 1984-08-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to
Guideline:
other: see references below
Deviations:
not applicable
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not applicable
Principles of method if other than guideline:
Test is perfomed according to the following references:
-Draize, J. H.; Woodward, G.; Calvery, H. O. : j. Pharmacol. Exp. Therap., 82, 377 -390, 1944
- Draize, J.H.: Appraisal of the safety of chemicals in foods, drugs and cosmetics, 46 -59, Assoc. of Food and drug officials of the united states, Topeka, Kansas, 1965
- OECD Guedline for testing of chemicals, OECD, ISBN-92 - 64 - 12221 -4, 1981
GLP compliance:
no
Species:
rabbit
Strain:
other: white Russian
Details on test animals and environmental conditions:
body weight: 2.0 - 2.5 kg
age: 6-8 months
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
500 mg of the test item was moistened with 0.15 mL water.
Duration of treatment / exposure:
The duration of exposure was 4 hours. The duration of treatment was 1, 24, 48 and 72 hours after application.
Observation period:
Observation period was 21 days after the application.
Number of animals:
3
Details on study design:
NA
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
NA
Other effects:
No other effects.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance sodium cyanate revealed only minimal skin irritating effects in rabbits (edema score 0.22, erythema score 0).
Executive summary:

In a primary dermal irritation study 6-8 months old White Russian rabbits (3 animals, sex not specified) were dermally exposed to 0.5 g of sodium cyanate (98 %) moistened in 0.15 mL water for 4 hours. Animals then were observed for 14 days. Irritation was scored by the method of Draize. The substance sodium cyanate revealed only minimal skin irritating effects in rabbits (mean edema score 0.22 - one of three animals score 0.66 , mean erythema score 0). Effects were reversible within 72 h. In this study, sodium cyanate is not a dermal irritant.

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:
1984-09-04 to 1984-09-25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
non-GLP study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
OECD 1981
Deviations:
no
Principles of method if other than guideline:
NA
GLP compliance:
not specified
Species:
rabbit
Strain:
other: white Russian
Details on test animals or tissues and environmental conditions:
body weight: 2.4 - 2.75 kg
age: 6-7 months
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated left eye served as negative control.
Amount / concentration applied:
0.1 g test item was applied once in rabbit´s eye.
Duration of treatment / exposure:
The subsatnce was applied one to the rabbit's eye (without washing).
Observation period (in vivo):
Examinations: 1, 24, 48 and 72 hours after application and thereafter once per day.
The observation period was 21 days after application.
Number of animals or in vitro replicates:
3 ( female)
Details on study design:
NA
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
(extent of opacity area)
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Remarks:
(extent of opacity area)
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Remarks:
(extent of opacity area)
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
(extent of opacity area)
Basis:
mean
Time point:
24/48/72 h
Score:
0.44
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
24/48/72 h
Score:
1.11
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Not indicated.
Other effects:
No other effects.

Additional results:

irriation parameter                               Basis                  Time point       results       Max. scroce        Reversibility

conjunctivae score (secretion)          animal #1            24/48/72 h        0.33          3                         fully reversible within: 48 hours       

conjunctivae score (secretion)          animal #2            24/48/72 h        0                3                  

conjunctivae score (secretion)          animal #3            24/48/72 h        0                3                        

conjunctivae score (secretion)          mean                   24/48/72 h        0.11          3                         fully reversible within: 48 hours       

  

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance Sodium cyanate revealed only very weak irritating effects to rabbit´s eye (mean 24/48/72 h scores: cornea score 0.22, iris score 0.22, conjunctivae score 1.11, chemosis score 0) wich were reversible within at least 3 days.
Executive summary:

In a primary eye irritation study, 0.1 g of sodium cyanate (98 %) was instilled into the conjunctival sac of the right eye of 6-7 months old White Russian rabbits (3 females) for 72 h hours. Animals then were observed for 21 days. Irritation was scored by the method of Draize. The substance Sodium cyanate revealed only very weak irritating effects to rabbit´s eye (mean 24/48/72 h scores: cornea score 0.22, iris score 0.22, conjunctivae score 1.11, chemosis score 0) which were reversible within at least 3 days. None of the individual animals showed a mean score over 24/48/72 h treatment higher than the threshold values given in 67/548/EEC and Regulation (EC) No 1272/2008.

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

Respiratory irritation

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

Additional information

Skin:

Key study:

In a primary dermal irritation study 6-8 months old White Russian rabbits (3 animals, sex not specified) were dermally exposed to 0.5 g of sodium cyanate (98 %) moistened in 0.15 mL water for 4 hours. Animals then were observed for 14 days. Irritation was scored by the method of Draize. The substance sodium cyanate revealed only minimal skin irritating effects in rabbits (mean edema score 0.22 - one of three animals score 0.66 , mean erythema score 0). Effects were reversible within 72 h. In this study, sodium cyanate is not a dermal irritant.

Supporting study:

In a primary dermal irritation study, 4-5 month old White Russian rabbits (3 animals, sex not specified) were dermally exposed to 0.5 g of sodium cyanate (90 %) moistened with 0.3 mL water for 4 hours. Animals then were observed for 14 days. Irritation was scored by the method of Draize.

Sodium cyanate showed no skin irritating effects (edema and erythema scores 0) In this study, sodium cyanate is not a dermal irritant.

Eye:

Key study:

This study was chosen as key study, as it was conducted with the purest sodium cyanate preparation available (98 %, instead of 90 %).

In a primary eye irritation study, 0.1 g of sodium cyanate (98 %) was instilled into the conjunctival sac of the right eye of 6-7 months old White Russian rabbits (3 females) for 72 h hours. Animals then were observed for 21 days. Irritation was scored by the method of Draize. The substance Sodium cyanate revealed only very weak irritating effects to rabbit´s eye (mean 24/48/72 h scores: cornea score 0.22, iris score 0.22, conjunctivae score 1.11, chemosis score 0) which were reversible within at least 3 days. None of the individual animals showed a mean score over 24/48/72 h treatment higher than the threshold values given in 67/548/EEC and Regulation (EC) No 1272/2008.

Supporting study:

In a primary eye irritation study, 0.1 g of sodium cyanate (90 %) was instilled into the conjunctival sac of the right eye of 5 months old White Russian rabbits (3 females) for 72 h hours. Animals then were observed for 21 days. Irritation was scored by the method of Draize. The substance Sodium cyanate revealed slightly irritating effects to rabbit´s eye (mean 24/48/72 h socres: cornea score 0.11, iris score 0.33, conjunctivae score 1.89, chemosis score 0.44) wich were reversible within at least 7 days. Two out of 3 animals showed a conjunctivae score of >= 2. In this study sodium cyanate with up to 10% sodium carbonate is an eye irritant according to 67/548/EEC and Regulation (EC) No 1272/2008.


Justification for selection of skin irritation / corrosion endpoint:
Most reliable study was chosen.

Justification for selection of eye irritation endpoint:
Most reliable study was chosen.

Justification for classification or non-classification

The classification and labelling was made based on the results of the key studies (98% product).

Skin and eye irritation:

Based on the available experimental data, the test item is not considered to be classified for skin irritation or eye irritation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.