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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

1
Chemical structure
Reference substance name:
Ethyl cyano(hydroxyimino)acetate
EC Number:
223-351-3
EC Name:
Ethyl cyano(hydroxyimino)acetate
Cas Number:
3849-21-6
Molecular formula:
C5H6N2O3
IUPAC Name:
ethyl cyano(hydroxyimino)acetate

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Controls:
yes
Amount / concentration applied:
single patch 6 cm2
Duration of treatment / exposure:
4h
Observation period:
1 animal was observed until 72 h after Test item removal by which time all dermal reactions had resolved. .2 animals were observed 9 days after Test Item removal by which time all dermal reactions had resolved.
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #3
Time point:
72 h
Score:
>= 1.2
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
ca. 2
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
ca. 2
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
ca. 2
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
ca. 1
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
ca. 2
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
ca. 2
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Irritant / corrosive response data:
Initial test ( animal #6795)
In the initial Test, slight erythema (grade1) was noted 1 hour after patch removal. The severity increased to grade 2 at 24 to 72 hours. At day 6 the erythema disappeared. No edema was noted at any of the observations. Other skin reactions observed were, scattere white scaling observed on days 6, 7 and 8.

Confirmatory Test ( Animal #6305):
In the Confirmatory Test slight erythema (grade1) was noted 1 hour after patch removal. The erythema had resolved at 24 hours post patch removal. No edema or other skin reactions were observed.

Confirmatory Test ( Animal #6792):
In the second Confirmatory Test slight erythema (grade1) was noted 1 hour and 24 hours after patch removal. At 48 and 72 hours moderate erythema (grade2) was noted. At day 5 erythema was resolved. At day 8 slight erythema (grade1) was noted ( after disappearance of the scaling), which was resolved at day 9. No edema was noted in any of the observations. Other skin reactions noted were mild (grade1) white scattered scaling observed on days 5, 6 and 7.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
CLP classification: H315 Skin irrit 2.
In consideration of a calculated Primary Irritation Index (PII) of 1.2, Oxymapure is categorized as a "slight" dermal irritant.
Executive summary:

CLP classification: H315 Skin irrit 2.

In consideration of a calculated Primary Irritation Index (PII) of 1.2, Oxymapure is categorized as a "slight" dermal irritant.