Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted by a GLP accredited laboratory using OECD Testing Guideline 420.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped

EC Number:

941-627-8

Molecular formula:

Not Applicable

IUPAC Name:

Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped

Constituent 2

Reference substance name:

Not assigned

IUPAC Name:

Not assigned

Test material form:

other: Liquid

Details on test material:

Name of test material: Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped
Physical state: Black liquid
Substance type: UVCB
Storage conditions: Room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Female Wistar (RccHan™:WIST) strain rats were supplied by Harlan Laboratories UK Ltd., Oxon, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non-pregnant. After an acclimatization period of at least five days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the study the animals were eight to twelve weeks of age. The body weight variation did not exceed ±20% of the body weight of the initially dosed animal.

The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analyzed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.

The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Rats are the preferred species of choice as historically used for safety evaluation studies and are specified in the appropriate test guidelines.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

For the purpose of the 2000 mg/kg dose level, the test item was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level. For the purpose of the 300 mg/kg dose level, the test item was freshly prepared, as required, as a solution in arachis oil BP. Arachis oil BP was used because the test item did not dissolve/suspend in distilled water.

The test item was formulated within two hours of being applied to the test system. It is assumed that the formulation was stable for this duration.

No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. This is an exception with regard to GLP and has been reflected in the GLP compliance statement.

Doses:

- 300 mg/kg
- 2000 mg/kg

No. of animals per sex per dose:

1 animal received a dose of 300 mg/kg, 5 animals received a dose of 2000 mg/kg

Control animals:

no

Details on study design:

Duration of observation period following administration: 14 days
Frequency of observations and weighing: Day 0 (prior to dosing), Day 7, Day 14, and at death.
Necropsy of survivors performed: yes
Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:

Dose level 300 mg/kg: No mortality, no signs of systemic toxicity noted during the observation period, the animal showed expected gains in body weight over the observation period and no abnormalities were noted at necropsy. Based on the results at a dose level of 300 mg/kg, a dose level of 2000 mg/kg body weight was investigated.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths were recorded

Clinical signs:

other: At 2000 mg/kg - Hunched posture and red/brown staining around the mouth and snout were noted in the initial treated animal. This animal appeared normal 2 days after dosing. No signs of systemic toxicity were noted in the four additional treated animals du

Gross pathology:

No abnormalities were noted at necropsy

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.

Executive summary:

The acute toxicity: oral of the test substance was determined in accordance with the OECD Guideline for Testing of chemicals 420. Following a sighting test at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test item at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. At dose level 300 mg/kg there was no mortality, no signs of systemic toxicity noted during the observation period, the animal showed expected gains in body weight over the observation period and no abnormalities were noted at necropsy. Based on the results at a dose level of 300 mg/kg, a dose level of 2000 mg/kg body weight was investigated. At dose level 2000 mg/kg there was no mortality, all animals showed expected gains in body weight and no abnormalities were noted at necropsy. Hunched posture and red/brown staining around the mouth and snout were noted in the initial animal treated at a dose level of 2000 mg/kg. There were no other signs of systemic toxicity noted. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.