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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:
04 - 09 Aug 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
28 Jul 2015
Deviations:
yes
Remarks:
(all 3 animals were tested in parallel, no initiating and confirmatory test performed)
GLP compliance:
yes (incl. certificate)
Remarks:
Bayrisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
HsdIf:NZW
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: at least 2 kg bw
- Housing: housed in ABS - plastic rabbit cages, floor 4200 cm²
- Diet: Altromin 2123, ad libitum
- Water: tap water, ad libitum)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
Duration of treatment / exposure:
4 h
Observation period:
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6 cm² on the dorsal area of the trunk
- Type of wrap if used: The test substance was applied to a gauze patch which was applied to the skin and fixed with a non-irritating, semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with tap water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
Reading time points: 1, 24, 48 and 72 h

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test item showed neither irritant nor corrosive effects on the intact skin of 3 rabbits after a contact time of 4 h.
Other effects:
Body weight evolution appeared normal.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
Conclusions:
CLP: not classified