Oxidised Crude Tall Oil

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Oxidised Crude Tall Oil

EC Number:

938-639-0

Molecular formula:

C17-20H29-35CO2H. O6-10

IUPAC Name:

Oxidised Crude Tall Oil

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 or test system 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

Results

Results 1

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

Results 2

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.