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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive dressing, 24 hours exposure duration, only 24- and 72-hour scoring available, 72-hour observation period
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Physical state: brown powder
Specific details on test material used for the study:
- Physical state: brown powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Porton strain bred on the premises
- Age at study initiation: 3-4 months
- Weight at study initiation: ca. 2.23 kg for males and 2.55 kg for females
- Housing: caged singly in an experimental room
- Diet (e.g. ad libitum): commercial irradiated diet (Styles-Oxoid); ad libitum
- Water (e.g. ad libitum): sterile filtered drinking water; ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1°C
- Humidity (%): 50-70%
- Photoperiod (hrs dark / hrs light): 10/14

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved or abraded (only data from the shaved skin sites are presented here, since they are suitable for assessment)
Vehicle:
other: 50% aqueous solution of polyethylene glycol
Controls:
other: untreated skin sites of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 10 g of the test compound was mixed with 20 ml of a 50% aqueous solution of polyethylene glycol to make a solution of 25ml, 1.25ml of which was applied to each test site.
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 (3 males and 3 females)
Details on study design:
TEST SITE
- Area of exposure: at least 10% of the total body surface (the whole back) was shaved 24 hours before treatment). The shaven skin on the rightt side was slightly scarified immediately before treatment. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact.
- % coverage: a 2.5 cm square gauze pad was used
- Type of wrap if used: the pad was covered with aluminium foil secured with Sleek adhesive tape. The test sites were then enclosed by a 6" wide Coban self adhesive bandage, the edges of which were fixed to the skin by strips of Sleek in order to retain the test substance in close contact with the skin.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: the gauze patches were removed 24 hours after the application

SCORING SYSTEM: comparable to the OECD scoring system (only 24- and 72-hour scores were determined)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
Mean of all tested animals
Time point:
other: 24-72-hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: 48-hour scoring not performed
Irritation parameter:
edema score
Basis:
mean
Remarks:
Mean of all tested animals
Time point:
other: 24-72-hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 48-hour scoring not performed
Irritant / corrosive response data:
No erythema formation was observed, neither on intact skin sites nor on the abraded ones. Edema was observed in all but one animals after 24 hours on intact skin sites (one animal with edema score 2 and 4 animals each with edema score 1), and in 4/6 animals at abraded skin sites (one animal with edama score 2 and 3 animals each with edema score 1). The edema formation was completely reversible within 72 hours. It could therefore be assumed that the test substance is not irritating according to EU-CLP.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information