Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: see references below
Deviations:
not applicable
Qualifier:
equivalent or similar to guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium cyanate
EC Number:
213-030-6
EC Name:
Sodium cyanate
Cas Number:
917-61-3
Molecular formula:
CNO.Na
IUPAC Name:
sodium cyanate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
other: white Russian
Details on test animals or test system and environmental conditions:
body weight: 2.0 - 2.5 kg
age: 6-8 months

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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.

Applicant's summary and conclusion

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.