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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:
November 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Royal Decree 363/1995, of 10 March
Deviations:
not specified
Qualifier:
according to
Guideline:
other: Royal Decree 1078/93 of 2 July
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: authorized breeder.
- Weight at study initiation: 2001, 2453, 2607 g
- Housing: single housed in a stainless steel cage, brand Tecniplast.
- Diet: daily dose of 150 g special diet for rabbits experimental provided by an authorized provider.
- Water: filtered tap water, ad libitum.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2°C
- Humidity: 55 ± 25 %
- Air changes: 15 ACH with air filtered 5 µm.
- Photoperiod: 12 hour cycle dark/light

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
moistened
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
24, 48, 72 hours, 7, 14 and 21 days
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: 20 cm x 13 cm
- Coverage: 6 cm^2
- Type of wrap if used: Gauze type dressings (Melolin) or equivalent, Sticking plaster, hypoallergenic adhesive bandage (Fixomull Seretch) or equivalent.

REMOVAL OF TEST SUBSTANCE
- Washing: yes; after the exposure period the substance is gently removed with water or suitable solvent.

EVALUATION OF SKIN REACTIONS
Eschar formation
No erythema...................................................0
Very slight erythema (barely perceptible)......1
Well-defined erythema....................................2
Moderate to severe erythema.........................3
Severe erythema to slight eschar formation...4

Oedema formation
No oedema..............................................................................................................0
Very slight oedema (barely perceptible).................................................................1
Slight oedema (edges well-defined)........................................................................2
Moderate oedema (raised ca. 1 mm).......................................................................3
Severe oedema (raised more than 1 mm; extending beyond area of exposure)....4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: shaved skin
Irritation parameter:
erythema score
Basis:
other: animal 2 and 3
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: shaved skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: shaved skin
Other effects:
In the three animals was observed a brown skin coloured into the application site. This effect persists after 21 days in the rabbit no. 1 and disappears after 14 days in the rabbits no. 2 and no. 3.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified, according to the Regulation EC 1272/2008 (CLP)
Conclusions:
The substance was found to cause no irritation when applied to intact rabbit skin.
Executive summary:

The substance has been tested for skin irritation according to the procedure inside the Spain Royal Decree 363/1995 and Royal Decree1078/93.

Three male rabbits are tested with 0.5 g of test item to the shaved skin after 4 hours of patch treatment. The scores of each animal at the reading times of 24, 48 and 72 hours was used in calculating the respective mean values for each type of lesion.

 

The values of erythema and oedema, calculated as mean individual scores at 24, 48 and 72 hours, are below the trigger values for classification (2.3), therefore the substance is not classified under the CLP Regulation (EC n. 1272/2008).