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Toxicological information

Skin irritation / corrosion

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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:
other: well performed OECD and GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2'-methoxyacetoacetanilide
EC Number:
202-131-0
EC Name:
2'-methoxyacetoacetanilide
Cas Number:
92-15-9
Molecular formula:
C11H13NO3
IUPAC Name:
N-(2-methoxyphenyl)-3-oxobutanamide
Details on test material:
- Name of test material (as cited in study report): Acetessig-o-anisidid TTR

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
500 mg mixed with 0.35 ml physiol. saline
Duration of treatment / exposure:
Exposure period: 4 hrs. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.
Observation period:
72 hrs
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: mean of animal # 1, 2 each
Time point:
other: Mean of 24, 48, 72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
other: no effects at any time
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 h
Score:
0.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
edema score
Basis:
other: mean of animal # 1, 2, 3 each
Time point:
other: mean of 24, 48, 72h
Score:
0
Reversibility:
fully reversible
Remarks on result:
other: no effects at any time
Irritant / corrosive response data:
No signs of irritation/corrosion except very slight erythema in a single animal (at 24h) have been observed during the entire study period.
Other effects:
no other effects, during entire study period

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Acetoacet-o-anisidide was neither skin irritating nor skin corrosing in this test.
Executive summary:

Acetessig-o-anisidid TTR was tested for its skin irritating or skin corrosive properties according to OECD 404.

Following this protocol 500 mg Acetessig-o-anisidid mixed with 0.35 ml of physiol. saline was applied to the shaved skin of New Zealand albino rabbits. After four hours exposure time the semiocclusive covering was removed and the application site carefully rinsed to remove adhesive substance. In the following 72 hours the animals were periodically examined for signs of skin irritation and or corrosion. Mean scores (mean of 24, 48, 72 h) were calculated for oedema and erythema for each rabbit.

All calculated mean scores were 0 except for one rabbit whose mean score for erythema amounts to 0.3 but was fully reversible within 48h. Based on these findings the test substance is neither skin irritating nor skin corrosive in this test.