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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: No deviation from OECD-404 guideline, GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
GLP Certificate as an annexe in the study report.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
yes
Duration of treatment / exposure:
72 hours.
Observation period:
1, 24, 48 and 72 hours.
Number of animals:
3 animals per dose.
Details on study design:
The test product was applied, after being heated at 80°C, at a dose of 0.5 ml/L, on an undamaded skin area of the right flank of the animal. On the left flank an untreated area was served as the control.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72h
Score:
ca. 0
Max. score:
0
Reversibility:
other: not relevant, as no effect.
Remarks on result:
other: no erythema & eschar, no oedema at all time points of the study

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No erythema & eschar, no oedema at all time points of the study, primary irritation score is 0.0. It can be concluded that APP-6505 is not irritant to skin and that no classification is needed for this endpoint.
Executive summary:

The susbtance APP-6505 (Amyl xyloside) was applied, after being heated, under semi-occlusive dressing during 4 hours on an undameded skin area of three New Zealand rabbits at the dose of 0.5 ml, according to OECD-404 guideline. No cutaneous reactions, erythema and oedema, were observed whatever the examination time. Results enabled to conclude that the substance is not a skin irritant and doesn't need any classification for this endpoint.