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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Analytical purity of test substance not specified, 1.5 mL/ 100 g bw of non aqueous liquid administered at once.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
analytical purity of test substance not specified, 1.5 mL/ 100 g bw of non aqueous liquid administered at once
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Acrawax C, Disp. 52-464, (GC-Q7)
- Analytical purity: no data
- Lot/batch No.: 125257
- Stability under test conditions: stable under ambient storage condition during time of the study
- Storage condition of test material: ambient room temperature
- Other: Source: Glyco Inc.

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Kingston, New York
- Weight at study initiation: males 112-131 g and females 87-103 g
- Fasting period before study: over night (~18 h)
- Housing: Animals were housed five per cage by sex in suspended solid-bottom polycarbonate cages. The cage dimensions were 55.9 x 31.8 x 20.3 cm and were fitted with grommets to fit the external-to-cage watering system.
- Diet (e.g. ad libitum): ad libitum (NIH 07 Open Diet, Zeigler Bros., Inc., Gardners, PA)
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 10 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): mean 24, range 20-27
- Humidity (%): mean 47 , range 32-72
- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 15 mL/kg bw in 3 doses to a total of 45 mL/kg bw
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 15 mL/kg bw








Doses:
single dose of 5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: 5 animals of each sex served as vehicle controls
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed 4x on the day of treatment, and the observations were separated by 1-1 1/2h. On the 13 remaining days of the study the animals were observed 2x each day (AM and PM), and the observations were separated by at least 4h.
- Necropsy of survivors performed: yes, external examination including body orifices, and an internal examination of all of the following tissues: Gross lesions; skin; mandibular lymph node; mammary gland; salivary gland; thigh muscle; sciatic nerve; sternebrae, vertebrae or femur including marrow; costochondral junction, rib; thymus; larynx; trachea; lungs and bronchi; heart; thyroid; parathyroids; esophagus; stomach; duodenum; jejunum; mesentery; aorta; ileum; colon; cecum; rectum; mesenteric lymph node; liver; pancreas; spleen; kidneys; adrenals; urinary bladder; seminal vesicles; prostate; testes; ovaries; uterus; nasal cavity; brain; pituitary; spinal cord (if neurologic signs are present); eyes
- Other examinations performed: All gross observations were recorded by animal on Acute Study Data Sheets, and the terminology was in accordance with the appended list. Initial, 7 day, 15 day and final body weights were also recorded for each animal.
Statistics:
- Weight gain was calculated by (14 Day Body Weight - Mean Initial Body Weight)/Mean Initial Body Weight
- No other statistical tests were mentioned

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
not observed
Clinical signs:
not observed
Body weight:
no abnormalities observed
Gross pathology:
no abnormalities observed
Other findings:
- Other observations: The "ruffled coat" and diarrhea noted among vehicle controls was attributable to the large volume of vehicle (corn oil) received by these animals.

Any other information on results incl. tables

The absence of any adverse reaction relating to treatment like mortality, abnormal clinical signs, depressed growth rate or gross anatomical abnormalities at necropsy indicates that the test substance is non-toxic for F344 rats.

According to the criteria laid down in Regulation (EC) 1272/2008 and Directive 67/5438/EEC the substance does not have to be classified for acute toxicity via the oral route.

Applicant's summary and conclusion