Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From September 17, 2002, to October 1, 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Pellicer
IUPAC Name:
Pellicer
Details on test material:
Chemical name: sodium salt as a condensation product of N-lauroyl-L-glutamic acid and L-lysine
Secondary name: LGM
Lot number: 2L-7
Description: clear colorless liquid
Purity: 30.0 wt%
Specific gravity: 1.06

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Sankyo Labo Service Corporation
- Age at study initiation: 5 weeks old
- Weight at study initiation: Mean: 106.8g for males and 98.0g for females
- Fasting period before study: 16 hours
- Housing: a group of five animals were housed on pulp bedding (Paper Clean, Japan SLC, Inc.,) in a flat-bottomed, polycarbonate cage.
- Diet: The animals had free access to pellet food (MF, Oriental Yeast Co., Ltd.) and water, except the period 16 hours before and 3 hours after administration during which only water was fed.
- Water: water was available throughout the study
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature: 23°C ± 2°C
- Humidity (%): 50% ± 10%,
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12 hours light followed by 12 hours darkness

IN-LIFE DATES: From: Day 0 To: End of study

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: - not applicable

MAXIMUM DOSE VOLUME APPLIED: volume not stated in study report

DOSAGE PREPARATION (if unusual): sample provided for testing without dilution and used as supplied.
Doses:
2,000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The observation for clinical signs was conducted on animal’s appearance, hair coat, position, posture, and behavior up to 6 hours after administration and on the following 14 days (everyday basis). During this period, food consumption and body weight were measured on the following days: the administration day, and 1, 2, 3, 4, 7, and 14 days after administration.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, food consumption
Statistics:
No statistics used.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No rats died during the study
Clinical signs:
No particular symptoms of appearance, posture, and behavior were found in any rats during the observation period.
Body weight:
All rats showed weight gain on the first day after administration, followed by steady increasing shifts. The weight gain for 14 days was also normal.
Gross pathology:
No significant changes were observed on the body surface, opening, cranial cavity, visceral organs in the pleuroperitoneal cavity, and lymph nodes

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, it was concluded that the administration of the product to rats in a dose of 2000 mg/kg resulted in no toxic effects.
Executive summary:

Single dose toxicity of sodium salt as a condensation product of N-lauroyl-L-glutamic acid and L-lysine in rats was investigated. The test was designed as a limit test, and a dose of 2000 mg/kg was administered to each male and female group of five Slc:Wistar rats.

The sample was provided for testing without dilution and administered in a single dose by oral gavage via a metal stomach tube. The viability and clinical signs of rats were observed for 14 days, during which their food consumption and body weight were measured. All rats were also examined by autopsy at the end of the observation period. Results showed that no rats died. In general, no significant changes were observed in any of the rats. Food consumption was normal throughout the observation period.

Body weight change showed steady increasing shifts, and the weight gain for 14 days was normal. In addition, no significant changes were observed in the autopsy report. Based on the above results, it was concluded that the administration of the product to rats in a dose of 2000 mg/kg resulted in no toxic effects.