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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:
27-10-2014 - 03-11-2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to the guideline under GLP, this was conducted as part of testing plan to meet the China Level III testing requirements

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): EnvaMul™200
- Substance type: UVCB
- Physical state: Dark brown, opaque, viscous liquid
- Analytical purity: UVCB 100%
- Lot/batch No.: 042313
- Stability under test conditions: stable
- Storage condition of test material: oom temperature, protected from light
- Expiry date: 23 -Apr-2015

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: WIL Research stock colony
- Age at study initiation: 10-11 months
- Weight at study initiation: 3491.7 -3767.1 g
- Housing: individually in suspended wire-mesh cages
- Diet: 150 g PMI Nutrition International, LLC, Certified HF Rabbit LabDiet® 5325 per day
- Water: municipal water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.6°C to 18.7°C
- Humidity (%): 32.5% to 45.7%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

VEHICLE: NA
Duration of treatment / exposure:
4 hours
Observation period:
up to 7 days (scoring at 30-60 minutes , 24, 48 and 72 hours after treatmeneversible earlier)t and on day 4 and 7 (if not reversable earlier))
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 X 2.5 cm
- Type of wrap if used: 2-ply gauze patch secured in place with Micropore™ tape, overwrapped with a gauze binder and secured with Dermiform
tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with disposable paper towels moistened with deionizedwater
- Time after start of exposure: after the 4 h exposure period

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0.9
Max. score:
1
Reversibility:
fully reversible within: 4 days (2 males), 7 days (1 female)
Remarks on result:
other: brown discoloration at all scoring times
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Other effects:
brown discoloration of the applicatoion site at all observations

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not irritating to the skin
Executive summary:

Rabbits (n=3) were treated with 0.5 mL test substance under semi-occlusion for 4 hours. Very slight erythema, which was fully reversible within 4 to 7 days was observed. The substance is considered to be not irritating to the skin.