Protein hydrolyzates, silk

Acute Toxicity: oral

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

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

Test material information

Constituent 1

Reference substance name:

hydrolyzed chicken sternal cartilage

IUPAC Name:

hydrolyzed chicken sternal cartilage

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.