D-pentose, oligomeric, C5 alkyl glycosides

Skin irritation / corrosion

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

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.