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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted in compliance with good laboratory practices (US FDA, 1987), and in accordance with OECD (1987)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline but not indication on TG
Principles of method if other than guideline:
The study was conducted in compliance with good laboratory practices (US FDA, 1987), and in accordance with OECD (1987) at Covance Laboratories (Madison, WI, USA).
Ten acclimated rats were given the test product at a single dose of 5000 mg/kg of body weight, which was administered as a single gavage dose at a volume of 15 mL of 0.33 g/mL solution per kg of fasted body weight.
Clinical observations were conducted at 1, 2.5, and 4 h after administration of the test product and daily thereafter for 14 days. Mortality checks were conducted twice a day (morning and afternoon) for 13 days, and again on the morning of Day 15. Body weights were determined before the test material administration (Day 1), and again on Days 8 and 15. At the end of the study, all animals were euthanized by an overexposure
to carbon dioxide and used for a macroscopic necropsy examination of the external surfaces of the carcass, all orifices, the thoracic and abdominal cavities, organs, and tissues.
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test product was a patented preparation of hydrolyzed chicken sternal cartilage (BioCell Collagen II ; USA Patents 6025.327; 6323319; 6780841) supplied by BioCell Technology, LLC (Anaheim, CA, USA). The test product was a food grade (nutraceutical) powder containing minimum 60% collagen type II, 20% chondroitin sulfate, 10% hyaluronic acid and 1% other proteoglycans as well as 0.1% lipid, and 8% ash IBC Labs (2004).

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
5000 mg/kg of body weight, which was administered as a single gavage dose at a volume of 15 mL of 0.33 g/mL solution per kg of fasted body
weight
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

By the end of the study (Day 14), all five female and five male rats were alive and showed normal appearance. All animals exhibited body weight gain during the study. Mean body weight gain varied between 108.6 ± 15.1 g in males and 44.2 ± 6.24 g in females. The weight gain represented 40.7 ± 5.1% of the initial body weight in males and 19.2 ± 2.8% of that in females. Macroscopic and gross pathology observations conducted at the necropsy examination revealed no visible lesions in any of the ten animals. The estimated oral LD50 values for male and female rats thus were determined to be greater than 5000 mg/kg of body weight.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
nontoxic
Executive summary:

A GLP, OECD Guideline test on a similar substance to protein hydrolyzates animal was conducted.

The result is a LD50 > 5.000 mg/kw bw, which indicates that protein hydrolyzates as a similar substance may be considered as nontoxic.