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:
7 Jan 2009 to 10 Jan 2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Deviations: occlusive dressing; 24h exposure; tested on abraded and non-abraded skin at 10% and 100% on each animal

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 28 July 2015
Deviations:
yes
Remarks:
occlusive dressing; 24h exposure; tested on abraded and non-abraded skin at 10% and 100% on each animal
GLP compliance:
yes

Test material

Reference
Name:
Unnamed

Test animals

Species:
rabbit
Strain:
other: Jla:JW
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Japan Laboratory Animals Inc.
- Age at study initiation: 18 weeks
- Weight at study initiation: 3.42 to 3.61 kg
- Housing: individual housed in aluminum cages with wire mesh bottoms
- Diet: RC4 pelleted diet (Oriental Yeast Co., Ltd., Lot No. 080916), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 5
- Humidity (%): 55 ± 25
- Air changes (per hr): 11 - 14
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 7 Jan 2009 To: 10 Jan 2009

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: liquid paraffin
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: 10 and 100% (w/w)

VEHICLE
- Lot/batch no.: PEK3961 (Wako Pure Chemical Industries, Co., Ltd.)


Duration of treatment / exposure:
24 h
Observation period:
24, 48 and 72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm² (2 areas with intact skin, 2 areas with abraded skin)
- Type of wrap if used: occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: after patch removal, application sites were wiped with absorbent cotton soaked with water for injection
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
24, 48 and 72 h (observation and scoring of primary skin irritation)
Clinical signs: immediately after patch removal, 1 h and 4 h after application and once daily thereafter until day 3 after application

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
100% test material and 10% test material in liquid paraffine
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
100% test material and 10% test material in liquid paraffine
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No skin reactions were observed in any animal after application of 10 and 100% test substance.
Other effects:
- Other adverse systemic effects: There were no abnormalities in clinical signs or body weight gain observed in any animal until the end of the observation period.

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:
The test substance did not exhibit skin irritating properties in the conducted study.