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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
March, 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
study conducted on the analogue substance; the read across justification is detailed in section 13. The Reliability of the Source Study is 2.
Justification for type of information:
The read across justification is detailed in section 13.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Qualifier:
according to
Guideline:
other: REAL DECRETO 363/1995, 10 march
Version / remarks:
1995
GLP compliance:
not specified

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: authorised supplier
- Weight at study initiation: 2033-2113 g
- Housing: Stainless steel single cage
- Diet: daily dose of 150 g experimental diet for rabbits, provided by an authorized vendor
- Water: filtered tap water (5 µm) , ad libitum
- Acclimation period: 7 days
- Health check: during observation period

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

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied:0.5 g
Duration of treatment / exposure:
4 hours of treatment
Observation period:
1, 24, 48 ,72 hours and 7 and 14 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: dorsal column area near the spine, forming a rectangle 20 cm x 13 cm
- area / coverage: 6 x 6 cm
- Type of wrap if used: simple bandage and covered in turn with a light hypoallergenic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing : yes

SCORING SYSTEM: erithema and edema (equivalent to OECD 404)

Erythema and eschar formation
0 - No erythema
1 - Very slight erythema (barely perceptible)
2 - Well defined erythema
3 - Moderate to severe erythema
4 - Severe erythema (beet redness) to slight eschar formation (injuries in depth)

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

 Table 1: erythema and oedema scores

Animal  Time  Erythema  Oedema
animal #1  1 hour 2 0
24 hours 2 0
48 hours 2 0
72 hours 1 0
animal #2 1 hour 1 0
24 hours 1 0
48 hours 1 0
72 hours 0 0
animal #3 1 hour 1 0
24 hours 1 0
48 hours 1 0
72 hours 0 0

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC) No. 1272/2008
Conclusions:
The test item was found to be not irritating to rabbit skin.
Executive summary:

The skin irritation potential of the test item was evaluated in an in vivo experimental study, according to a method similar to the OECD Guideline 404. The test item was applied to the shaved dorsal region of 3 male New Zealand White rabbits for a duration of 4 hours with an occlusive bandage, after which the bandage was removed and skin was evaluated for erythema and oedema after 1, 24, 48 and 72 hours, and 7 and 14 days.

The mean (24/48/72 hours) erythema scores for each animal were 1.67 (animal #1) and 0.67 (animals #2 and #3); the mean (24/48/72 hours) oedema scores were were 0 in all animals. The effects observed were fully reversible within 7 days.