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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:
05. Feb to 08 Feb 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Federal Register 38, No 187
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
FDA Federal Register 38, No 187, Patch-Test, occusive scarifized and intact skin
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Remazol-Brillantblau R spezial flüssig
- Substance type: preparation
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
SPF Himalayan Albino Rabbits: Hoe:HIMK(SPFWiga)
Source: Hoechst AG
Food: ERKA 8300
Supplier: Futtermittelwerke Robert Koch oHG Hamm
Water: Tap water
Food and water ad libitum
Single housing
Weight: 1.5 to 2 kg

In-life date: 05. Feb to 08 Feb 1979

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded (3x3 cm) and shaved (3x3 cm) skin
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
undiluted, 0.5 mL on 2.5 cmx2.5 cm gauze pads
Duration of treatment / exposure:
24 hours
Observation period:
up to 72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure shaved and scarified skin: 2.5x2.5 cm
- Area of exposure shaved skin: 2.5x2.5 cm
- Type of wrap if used: 6 to 8 cm wide PVC sheeting covered by elastic bandage


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours


SCORING SYSTEM: FDA Federal Register 38, No 187

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

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

Mean value of 6 animals

Primary Irritation Index (PII) = EEF24h-abraded + EEF72h-abraded + EEF24h-shaved + EEF72h-shaved + EF24h-abraded + EF72h-abraded + EF24h-shaved + EF72h-shaved / 4

EVALUATION:

0.0 - 0.5 non-irritant
0.6 - 3.0 slightly irritant
3.1 - 5.0 moderately irritant
5.1 - 8.0 severely irritant

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24+72 h
Score:
0.8
Max. score:
8
Irritant / corrosive response data:
Two rabbits still showed a minimal erythema (score 1) at 72 hours.
Other effects:
In two rabbits dry skin was observed at 48 and/or 72 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information based on evaluation of shaved skin Criteria used for interpretation of results: EU
Conclusions:
EU Classification: not irritating
FDA evaluation: slightly irritant