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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:
08 Jul - 16 Aug 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 guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in Apr 2002
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: Japanese white species (Kbs:JW)
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ina Breeding Center, Kitayama Labes, Co., Ltd., Nagano, Japan
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: 2.71 - 2.38 kg
- Housing: The animals were individually housed in aluminium cages (W350 x D550 x H350 mm) in stainless-steel automatic-washing racks.
- Diet: pelleted diet RC4 (Lot. No. 160330, 160414 from Oriental Yeast Co., Ltd.), 150 g/day
- Water: municipal tap water, ad libitum
- Acclimation period: 8 - 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.5 - 25.9
- Humidity (%): 48.2 - 65.4
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 19 Jul 2016 To: 23 Jul 2016

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped and thereafter shaved
Vehicle:
other: olive oil
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g

VEHICLE
- Amount(s) applied: 0.5 mL olive oil was dropped and blended well with the test substance.
Duration of treatment / exposure:
4 h
Observation period:
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm on the dorsal area of the drunk

REMOVAL OF TEST SUBSTANCE
- After patch removal, the test substance remaining on the skin was removed as much as possible (not further specified)

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
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
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
No skin reaction was observed on the skin in any rabbit after 24, 48 and 72 h of observation.

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:
A reliable study conducted in accordance with OECD 404 and GLP, found the test material to be non-irritating to the skin of rabbits.