L-Lysine, N2,N6-bis[N-(1-oxododecyl)glutamyl]-, sodium salt (1:?)

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Initiation of study: November 9, 2009 Termination of study: December 15th 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies which did not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)

Deviations:

no

GLP compliance:

yes

Remarks:

Study was conducted according to OECD Principles of Good Laboratory Practice (as revised in 1997), ENV/MC/CHEM(98)17.

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Pellicer

IUPAC Name:

Pellicer

Details on test material:

Lot No.: K80042
Storage condition: Refrigeration (1 to 9°C) hermetically closed
Storage place: Refrigerator in test substance preparation room, Building No.7, BSRC
Duration of storage: November 6, 2009 to January 20, 2010 (days of receipt to return to the sponsor)
Appearance: Colorless, (or pale yellow) transparent liquid having subtle unique smell

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

28 days

Frequency of treatment:

Daily

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 100, 300 and 1000 mg/kg/day
Basis:
actual ingested

No. of animals per sex per dose:

5 males and 5 females per dose group


Recovery study groups
Test group 5 0 5 males and 5 females
Test group 6 5 5 males and 5 females

Control animals:

yes

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

> 1 000 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: overall effects none

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

Clinical signs:

There were no deaths and no adverse signs in any of the groups throughout the treatment and recovery periods.

Body weights: Body weights in all the treatment groups were equal to those in the control groups throughout the treatment and recovery periods.

Food consumption: Food consumption in all the treatment groups were equal to those in the control group throughout the treatment and recovery periods.

Applicant's summary and conclusion

Conclusions:

From these results, the no-observed adverse effect level, NOAEL, of Pellicer L-30 was considered to be more than 1,000 mg/kg/day under the conditions of the present study.

Executive summary:

The repeat dose study was conducted following OECD guideline 407. From these results, the no-observed adverse effect level, NOAEL, of Pellicer L-30 was considered to be more than 1,000 mg/kg/day under the conditions of the present study.

The study was is in addition to the standard Annex VII requirements and was conducted for compliance with non-EU regulatory requirements.