Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15-10-2013 - 18-11-2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to the guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Tall Oil, Polymd, Oxidised (Envamul 200)
IUPAC Name:
Tall Oil, Polymd, Oxidised (Envamul 200)
Test material form:
liquid: viscous
Details on test material:
The CAS name quoted above together with the pertinent CAS number (68815-17-8) has been used to identify this substance. This CAS number is listed on some inventories as :-
“Tall oil, polymd, oxidized” (TSCA, USA)
“Tall oil, polymerized, oxidized” (AICS, Australia)
“Tall oil, polymd, oxidized” (ENC, Japan)
“Tall oil, polymd, oxidized” (KECI, Korea)
“Tall oil, polymd, oxidized” (DSL, Canada)

However, GPC analysis has confirmed that this substance, Oxidised Crude Tall Oil is not a polymer as this CAS name implies. Elsewhere in this dossier the term "Oxidised Crude Tall Oil" has been used to describe this substance which is believed to be a better description of this substance.
Thus, the name "Tall oil, polymd, oxidized" has, historically, been used to describe this substance in error.


- Substance type: UVCB
- Physical state: Dark brown, viscous liquid
- Analytical purity: 100%
- Lot/batch No.: HPQD09T060
- Storage condition of test material: Stored in tightly closed original container in a dry and well-ventilated place at room temperature. Kept in original container.
- Supplier: MeadWestvaco Corporation

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
Female rats, obtained from Charles River Canada, Montreal, Quebec (body weight range 200.2 - 208.0 g [after fasting]) were individually housed in solid bottom cages. Individual animals were identified by colour coding; the animal number and group number also appeared on the outside of each cage to preclude mix-up. The animal room environment was controlled (targeted ranges : temperatures 19 - 25 degrees C, relative humidity 30 - 70%, minimum 10 air changes per hour) and monitored. The photo-cycle was 12 hours light and 12 hours dark. Upon arrival all animals were submitted to a general physical examination and all were found healthy and were admitted. Teklad Certified Rodent Diet and water were offered ad libitum throughout the acclimatization (7 days).

The cage cleaning schedule, air filtration and recirculation, health checks and facility maintenance were carried out in accordance with the applicable Nucro-Technics' Standard Operating Procedures, and such activities were recorded in the animal room records.

Animals were housed and maintained according to the AAALAC International Guide for Care and Use of Laboratory Animals (https://www.aaalac.org/about/guidelines.cfm), CCAC Guidelines for Care and Use of Experimental Animals (http://www.ccac.ca/en_/standards/guidelines) and Nucro-Technics Standard Operating Procedures.

All animals used for the Limit test were fasted overnight. Food, but not water, was withheld beginning at 4.00 pm on the day preceding dosing, and was returned to the cages approximately 1 hour after dosing.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.0 mL/kg bw
Schedule: Since this animal survived, four additional animals were sequentially dosed at 2-day intervals. A total of 5 animals were dosed.
Doses:
2000 mg/kg (limit test)
No. of animals per sex per dose:
5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: individally once during the first 30 minutes of dosing, periodically during the first 24 hours following dosing. Observations were subsequently carried out once daily for the remainder of the study. Cageside observations focused upon any changes in the skin and fur; eyes and mucous membranes; respiratory, circulatory, autonomic and central nervous system and also somatomotor and behavior patterns. Special attention was given to any observation of tremours, convusions, salivation, diarrhoea, lethargy sleep and/or coma.
The body weights were determined prior to test item administration (Day 0), on Day 7 and on Day 14. Body weights gains were calculated.
- Necropsy of survivors performed: yes
This included examination of:
External surfaces of the body, All orifices, Cranial cavity, External surfaces of the brain and spinal cord, Nasal cavity and paranasal sinuses, Thoracic, abdominal and pelvic cavities and viscera.





Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
other: None
Gross pathology:
No pathalogical findings were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 after oral administration of the test substance is > 2000 mg/kg.
Executive summary:

Female rats (n=5) received a single oral dose of 2000 mg/kg bw of the test substance. No effects on clinical signs, body weight and macroscopic examinations were observed. Since no mortalities were observed the LD50 was found to be> 2000 mg/kg bw.