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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Fully reported evaluation of irritancy on skin not following EC B.4 method but with longer skin contact times.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
Evaluation of skin irritation in the Guinea pig: trial to determine suitable challenge concentrations for use in a subsequent skin sensitisation assay.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
-
EC Number:
439-070-6
EC Name:
-
Cas Number:
125005-87-0
Molecular formula:
Not applicable
IUPAC Name:
(2R,3R,4S,5S)-2,3,4,5-tetrahydroxyhexanal (2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanal (2S,3S,4S,5R)-2,3,4,5-tetrahydroxy-6-oxohexanoic acid acetic acid calcium dihydride hydrate magnesium dihydride potassium hydride sodium hydride

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Details on test animals or test system and environmental conditions:
Male Guinea pigs 300-450g weight, housed singly or in pairs in solid-floor cages with woodflake bedding and free access to food and water. 12 hour light/dark cycle in animal room with target conditions 17-23 degrees C and 30-70% RH.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
other: dried Arachis oil
Controls:
not required
Amount / concentration applied:
Four different concentrations at separate sites on the clipped flanks: 5,10,25,50% (50% = maximum attainable concentration for topical application).
Duration of treatment / exposure:
24 hours
Observation period:
1,24 and 48 hours after dressing removal.
Number of animals:
2
Details on study design:
Test substance in vehicle applied on a saturated filter paper patch (circa 20 x 20 mm square) held against the skin by surgical adhesive tape and covered with aluminium foil under an adhesive bandage.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: No oedema observed
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: No oedema observed
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
max test concentration, 50%
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 48 hours
Remarks:
No observations after 48 hours
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
max test concentration, 50%
Time point:
48 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
max test concentration, 50%
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
max test concentration, 50%
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 48 hours
Remarks:
No observations after 48 hours
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
max test concentration, 50%
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: No oedema observed
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
max test concentration, 50%
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: No oedema observed

Any other information on results incl. tables

A separate skin irritation trial was also performed to determine a suitable concentration for application during the induction phase of the Guinea pig sensitisation study: all aspects of this were identical to those of the challenge concentrations trial described here, except that the two test animals had been injected with Freund's Complete Adjuvant 15 days earlier and the occluded topical applications were maintained for 48 hours. In this trial, erythema scores for the maximum 50% test concentration were 2, 1, 0 (animal 1) and 2, 1, 1 (animal 2) at 1, 24 and 48h respectively. Oedema scores were zero at 1, 24 and 48h.

Applicant's summary and conclusion

Interpretation of results:
other: The prolonged period of occluded skin contact employed in the tests described (24-48h, compared to 4h in the B.7 method) is considered to compensate for the use of a maximum 50% concentration.
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Not classified for skin irritation under EU criteria.