Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
In vivo study previously available which addresses fully the endpoint requirements.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995-03-02 to 1995-03-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study (OECD 404)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
May 12, May 1981
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes

Test animals

Species:
rabbit
Strain:
other: "Kleine Weiße Russen, Chbb:HM, SPF"
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Chemisch-Pharmazeutische Fabrik, 88400 Biberach an der Riss 1, Germany
- Age at study initiation: adults
- Weight at study initiation: 2.5, 2.6 and 2.5 kg
- Housing: conventional, kept single in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity:30 - 70 %
- Air changes: 15 per h
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 1995-03-06 To: 1995-03-10

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
"VE-Wasser"
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g in 0.5 cm³ water
Duration of treatment / exposure:
4 hours
Observation period:
30 to 60 min, 24, 48 and 72h
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: dorsal trunk
- Coverage: approximately 6 cm²
- Type of wrap if used: gauze, covered by non irritating patch and semiocclusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: yes, warm water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize / Guideline OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean)
Time point:
other: 24, 48 and 72h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean)
Time point:
other: 24, 48 and 72h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean)
Time point:
other: 24, 48 and 72h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean)
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean)
Time point:
other: 24, 48 and 72h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean)
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The skin irritation/corrosion of 4-Hydroxy-TEMPO was tested in a standard OECD 404 guideline study. Classification: not irritating.