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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:
From December 21, 1993 to February 02, 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Similar Substance 01 - RY145
IUPAC Name:
Similar Substance 01 - RY145
Test material form:
solid
Details on test material:
- Similar substance 01: Reactive Red 195
- EC: 278-674-2
- CAS77365-64-1
- Internal batch: 761/93 (Sample about 750 g)
Content of dye: 67,5 %
Content of sodium sulphate: 32,0%
Rest: < 0,5%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Supplier: association of breeders in Hadrce Kralovè
- Weight: 2,5 Kg (prior the application)
- Health status: checked frorm parasite and patogen microrganisms, viruses and fungi
- Housing: acclimatized cages (Velaz Praha)
- Selection: 6 animals pro cage by gender
- Identification: by number on cages door
- Diet: KO-16 (Velaz Praha),
- Water: ad libitum, according to SN 757111
- Cleaning: disinfection of cages
- Acclimatization: quarantine
- Acclimatization period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature : 20 ± 3 °C
- Humidity: 50 ± 15 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
water
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
1 hour, 24, 48, 72 hours
Number of animals:
3
Details on study design:
DOSAGE PREPARATION: By Mettler AE 200
TEST SITE: Left and right side of the lateral surface of the abdominal area, located in epigastrium, mesogastrium, hypogastrium. Scarification of the area was performed. Area: 6x6 cm.
APPLICATION: Gauze, aluminum foil and cellulose wadding
DRESSING: Bandage

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 1

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Principles
Conclusions:
Non irritating for the skin
Executive summary:

Method

The substance was tested for irritation to the skin in rabbit, White New Zealand strain, according to OECD 404.

0.5 grams of the substance were applied on intact and abraded skin and reactions (erhythema and edema) were observed for 72 hours.

Clinical signs were also observed and primary irritation score and the degree of dermal irritation were evaluated.

Conclusion

After 72 hours of observation the registering substance was considered non irritant for the skin.

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