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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:
supporting study
Study period:
march 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
The test was conducted by means of Read Across approach. Further information was attached at 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
Guideline:
other: Royal Decree 363/1995 of March 10
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Acid Brown 188:2 - Similar Substance 01
IUPAC Name:
Acid Brown 188:2 - Similar Substance 01
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: authorized supplier.
- Weight at study initiation:1975-2076 g
- Housing: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 (°C): 21± 2°C
- Humidity (%):55 ± 25%
- Air changes (per hr):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:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied:0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
1,24,48,72 hours and 7, 14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure:dorsal-column area near the spine, forming a rectangle 20 cm x 13 cm .
- % coverage: 6 cm^2
- 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 (similar to OECD 404)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
ca. 0.44
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
other: not classified under Regulation 1272/2008
Conclusions:
Not irritant for skin
Executive summary:

The substance was tested for skin irritation with 3 New Zealand white rabbits with an occlusive method. After 72 hours of observation no rabbit shows signs of erythema or edema. The substance is classified as non-irritating to the skin.