Registration Dossier

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

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.