Hydrocarbon waxes (petroleum), oxidized

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8th Feburary 1993 to 17th March 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study performed in accordance with generally accepted scientific principles, with incomplete reporting on methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: 40 CFR Part 798, EPA Health Effects Testing Guidelines - Subpart B - General Toxicity Testing, September 1985.

Deviations:

yes

Remarks:

: observations were taken according to a different time scale. Day 7 bodyweights were taken on day 9 and female observations on day 4 were not taken.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbon waxes (petroleum), oxidized

EC Number:

265-205-1

EC Name:

Hydrocarbon waxes (petroleum), oxidized

Cas Number:

64743-00-6

Molecular formula:

too complex

IUPAC Name:

Hydrocarbon waxes (petroleum), oxidized

Test material form:

other: greasy solid

Details on test material:

- Physical appearance: Yellow pellets.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Buckshire Corp., Perkasie, PA 18944 (U.S.D.A. License # 23-BL).
- Animals were housed and maintained according to the Guide for the Care and Use of Laboratory Animals (NIH Publication No. 86-23).
- Weight at study initiation: 200 - 240 g, variation did not exceed ± 20% on the average weight for either sex.
- Fasting period before study: Overnight prior to dosing.
- Housing: Housed 5 per cage by sex, in stainless steel elevated wire cages.
- Diet (e.g. ad libitum): Wayne® Rodent BLOX® 8604 ad libitum.
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4 - 23.0 ºC.
- Humidity (%): 36 - 54 %.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.

IN-LIFE DATES: From: 24th February 1993 To: 10th March 1993

Administration / exposure

Route of administration:

oral: feed

Vehicle:

other: 4 ml peanut butter and 2 ml of honey.

Details on oral exposure:

- The dosed feed was completely consumed within 24 hours by all animals.

Doses:

- 5000 mg/kg bw.

No. of animals per sex per dose:

- 5 male and 5 female.

Control animals:

not specified

Details on study design:

OBSERVATIONS
- Duration of observation period following administration: 14 days. Observations were performed frequently on the day of dosing, then at least once daily.
- Frequency of weighing: Recorded at study initiation, day 9 and at sacrifice.
- Necropsy of survivors performed: Yes, on all animals which were euthanized with carbon dioxide.
- Other examinations performed: Signs of toxicity.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

- No mortalities were observed within the observation period.

Clinical signs:

other: - All animals appeared normal throughout the study.

Gross pathology:

- No abnormalities were observed in any animal.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test no mortalities were observed at the dose administered, therefore the LD50 is said to be > 5000 mg/kg, no other signs of systemic toxicity were observed. Thus according to Regulation (EC) 1272/2008 the test material does not require classification.

Executive summary:

In a GLP-compliant study performed following a protocol similar to 40 CFR Part 798 (EPA Health Effects Testing Guidelines - Subpart B - General Toxicity Testing, September 1985), the acute oral toxicity of the test material was determined. Ten male and female rats were exposed to the test material in a limit test at 5000 mg/kg bw, administered in their feed. No mortalities or systemic signs of toxicity were observed within the 14 hour observation period or at necropsy. Therefore it can be said that the LD₅₀ is > 5000 mg/kg, which according to Regulation (EC) 1272/2008 means the test material does not require classification.