Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20.1. - 3.2.1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
OECD Guidelines for Testing of Chemicals, Paris, 1992
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Other name: Ostazinová žluť H8-GSOURCE OF TEST MATERIAL- Source and lot/batch No.of test material: 920/389 (sample supplied by the sponsor)- Expiration date of the lot/batch: unlistedSTABILITY AND STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: at laboratory conditions

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
male/female
Details on test animals and environmental conditions:
- Source: Spolek chovatelů. Hradec Králové with veterinary health certificate; clinical examination confirmed the good state of health- Age at study initiation: not specified- Weight at study initiation: more than 2.5 kg- Housing: individually in metal cages (Velaz Praha)- Diet: ad libitum (standard granulated diet for rabbits TM-MAK1; Bergman)- Water: ad libitum (tap water acc. ČSN 757111)- Acclimation period: not specifiedENVIRONMENTAL CONDITIONS- Temperature (°C): 18±3- Humidity (%): 30 – 70%- Air changes (per hr): not specified- Photoperiod (hrs dark / hrs light): 12 /12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
only a bit moisturized with water before aplication
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48, 72 hours
Number of animals:
3 animals
Details on study design:
TEST SITE - Area of exposure: 6x6 cm - Type of wrap if used: A sample a bit moisturized with water was covered with gauze, Alu-foil and cellulose wadding as last layer and fixed by technical tape for contact of a substance with shaved skin. REMOVAL OF TEST SUBSTANCE - Washing (if done): not specified - Time after start of exposure: 4 hoursOBSERVATION TIME POINTS1, 24, 48, 72 hoursSCORING SYSTEM: see Any other information ...

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal: 20
Time point:
other: 1/24/48/72 h
Score:
0
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 1/24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 h
Score:
1
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1 h
Score:
1
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The sample, Ostazinová žluť H8-G, is not irritating to the skin of the rabbit.
Executive summary:

In the sample Ostazinová žluť H8-G, the skin irritation test was carried out on New Zealand white rabbit breeds.

Examination of skin irritation has shown that the sample is not irritating to the skin of the rabbit.

The skin irritation test was performed according to OECD methodology No. 404.