Oxidised Crude Tall Oil

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 Oct 2014 to 10 Nov 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to the guidelines, under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

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:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, NC
- Age at study initiation: ca. 10 weeks
- Weight at study initiation: Males 322-340 g; Females 217-266 g
- Fasting period before study: NA
- Housing: individually in stainless steel, wire-mesh cages suspended above cage-board
- Diet: PMI Nutrition International, LLC, Certified Rodent LabDiet ® 5002 ad libitum
- Water: Municipal water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.3ºC to 21.4ºC
- Humidity (%): 34.8% to 49.2%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Details on dermal exposure:

TEST SITE
- Area of exposure, coverage: 10% of body surface
- Type of wrap if used: gauze binders (<8 ply) that were secured with nonirritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with disposable paper towels moistened with tepid tap water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.01 mL/kg, 2000 mg/kg bw (density 0.997)

VEHICLE: none

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males + 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality 1, 2, and 4 hours post-application on study day 0 and twice daily thereafter
- Necropsy of survivors performed: yes (macroscopy)
- Other examinations performed:
clinical signs: 1, 2, and 4 hours post-application on study day 0 and daily thereafter (includes signs of irritation)
body weight: on day 0, 7 and 14

Statistics:

NA

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: no treatment related effects (no signs of irritation, brown discoloration of the application site)

Gross pathology:

no abnormalities detected

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the substance after dermal application is > 2000 mg/kg bw.

Executive summary:

Rats (5/sex) were treated dermally with 2000 mg/kg bw of the test substance. No mortality, effects on body weight, abnormal clinical observations or macroscopic effects were found in the 14 days observation period. The LD50 is therefore > 2000 mg/kg bw.