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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000, March
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Justification for type of information:
Justification for read across is detailed in the report attached to the IUCLID section 13.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Real Decree 363/1995 and Real Decree 1078/93
Principles of method if other than guideline:
Real Decree 363/1995 is the transposition of Directive 67/548/EEC in Spanish legislation
GLP compliance:
no
Remarks:
Centre Certificated ISO 9001 by National Accreditation Programme (certificate N. 98 - 1101)

Test material

Reference
Name:
Unnamed
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: authorized provider
- Weight: from 2.012 to 2.113 g
- Housing: inoxidable steel individual cage, Techiplast. Rabbit were maintained in cages for the total duration of the test
- Diet: daily 150 g of special fodder for experimental rabbit, by authorized provider
- Water: ad libitum, treated and filtrated
- Marking: tatoo on the upper side of ear
- Acclimatation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 25
- Air changes: 15 prefiltered air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 regulated by timer

USED GENERAL MATERIALS:
Balance: COBOS D 6000-SX
Vinyl/latex gloves mono-used
Syringes: 1 mL of volume
Shaver: electric AESCULAP mod. Favorita II
Gauzes dressing: Melolin or equivalent authorized
Adhesive bandage
Bandage: hypoalergenic adhesive Fixomull Seretch or equivalent authorized

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
Amount applied: 0.5 g of solid substance humidified with water for assuring a good contact to the skin
Duration of treatment / exposure:
4 hours
Observation period:
Observation at: 1, 24, 48 and 72 hours
Number of animals:
3 males
Details on study design:
TEST SITE
- Area shaved: retro-scapular side in the area around the vertebral column (20 cm of length and 13 cm of height).
- Area of exposure: 6 cm^2
- Type of wrap if used: gauzed dressing closed by adhesive bandage, covered with adhesive hypoalergenic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: water or specific solvent

SCORING SYSTEM:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4

Edema Formation
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4

If reactions are not reversible until 72h, it could be necessary an observation period of a maximum 14 days

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.44
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Observation: in rabbits 1 and 2, at 72 h lesions were fully reversible, while rabbit 3 does not show any irritating effects.

Any other information on results incl. tables

Erythema and edema

Time of observation  

  Rabbit 1 Rabbit 2 Rabbit 3
Erythema Oedema Erythema Oedema  Erythema  Oedema
1h   1  1  1  1  0  0
24h  1  1  1  0  0  0
48h  1  1  1  0  0  0
72h  0  0  0  0  0  0

Media erythema: 0.44

Media edema: 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Not skin irritant
Executive summary:

The substance was tested for skin irritation according to the Real Decree 363/1995 is the transposition of Directive 67/548/EEC in Spanish legislation

All lesions observed were all completely reversible maximum in 72 hours and one animal does not show any irritating effects. The tested substance is not considered as skin irritant.