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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
Study period:
01.02. - 16.02.1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Age: 14 weeks
Body weight: 2519-2646 grams
Acclimatisation: At least five days under test conditions
Conditions: Standard Laboratory Conditions. Air-conditioned with 7.5-15 air changes per hour and hourly monitored environment with temperature 20 ± 3°C and relative humidity 30-70%, 12 hours artificial fluorescent light /12 hours dark.
Accommodation: Individually in cages with perforated floors equiped with an automatic drinking system (ITL, Bergen I The Netherlands).
Diet: Standard laboratory rabbit diet approx. 100 gram per day.
Water:Free access to tap-water diluted with decalcified water.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: reverse osmosis water
Amount / concentration applied:
0.5 g (moistened)
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
other: mildly irritating
Executive summary:

Under the conditions of this study, 3-AMMP resulted in a primary irritation index of 0.3 (mildly irritating) when applied to the intact rabbit skin.The observed skin irritation consisted of very slight erythema. In one animal, also 3 brown spots with crust formation were observed. The irritation was reversible within 7 days after exposure. In the area of application, brown staining of the treated skin by test article was observed. No corrosive effect occurred on the skin and no signs of systemic intoxication were observed in any of the rabbits.