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Toxicological information

Acute Toxicity: oral

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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

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.