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Diss Factsheets

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:
07 Sep - 24 Nov 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 2002
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 2015
Deviations:
no
GLP compliance:
no
Remarks:
The study was conducted to meet the requirement of a regulation (Japan) other than Regulation (EC) No. 1907/2006 and therefore not conducted according to GLP.

Test material

Constituent 1
Chemical structure
Reference substance name:
Docosyl stearate
EC Number:
244-971-0
EC Name:
Docosyl stearate
Cas Number:
22413-03-2
Molecular formula:
C40H80O2
IUPAC Name:
docosyl octadecanoate

Test animals

Species:
rabbit
Strain:
other: Japanese White rabbits (Jla:JW)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: JLA, INC.
- Age at study initiation: 18 weeks
- Weight at study initiation: 2.94 - 3.38 kg
- Housing: The animals were individually housed in aluminium cages (W 560 x D 550 x H 410 mm) and given a plastic chain (polyethylene) as the environmental enrichment.
- Diet: RC4 pelleted diet (Oriental Yeast Co., Ltd., Lot No. 160518 and 160613), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: Yes, 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 24
- Humidity (%): 42 - 66
- Air changes (per hr): 11 - 14
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 07 Sep 2016 To: 24 Nov 2016

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g

VEHICLE
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
Initial test: 3 min, 1 and 4 h
Confirmatory test: 4 h
Observation period:
1, 24, 48 and 72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap: At the 3-min and 1-h exposure duration, the applied lint patch was covered with a tape [Tegaderm (3M Health Care)]. At the 4-h exposure duration, the applied lint patches (control and test substance) were covered with an elastic bandage [3M Coban Self-Adherent Wrap (3M Health Care)] and fixed with polyethylene film tape [KEEPPORE A (Nichiban Co., Ltd.)].

REMOVAL OF TEST SUBSTANCE
- Washing: The application sites were wiped with absorbent cotton soaked with water for injection [Lot No. 5J84 (Otsuka Pharmaceutical Factory, Inc.)].
- Time after start of exposure: 3 min, and 1 and 4 h, respectively

OBSERVATION 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
Remarks:
4 h of exposure
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Remarks:
1 h of exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Remarks:
3 min of exposure
Basis:
animal #1
Time point:
other: 1 and 24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Test was discontinued since no signs of skin corrosion (full thickness necrosis) were observed.
Irritation parameter:
edema score
Remarks:
4 h of exposure
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Remarks:
1 h of exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Remarks:
3 min of exposure
Basis:
animal #1
Time point:
other: 1 and 24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Test was discontinued since no signs of skin corrosion (full thickness necrosis) were observed.
Irritant / corrosive response data:
There were no skin corrosive or irritating reactions on any application site of the test substance (sites for 3-min, 1-h or 4-h exposure) of any animal at any observation point.

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