N6-(1-oxododecyl)-L-lysine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

2008

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test item was administered once orally in dosages of 1000 or 3000 mg/kg bw.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N6-(1-oxododecyl)-L-lysine

EC Number:

257-843-4

EC Name:

N6-(1-oxododecyl)-L-lysine

Cas Number:

52315-75-0

Molecular formula:

C18H36N2O3

IUPAC Name:

N6-(1-oxododecyl)-L-lysine

Test material form:

solid

Specific details on test material used for the study:

not further specified

Test animals

Species:

mouse

Strain:

ICR

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: Charles River Japan, Inc.
-Age at study initiation: 4 weeks
-Weight at study initiation: 20.2 - 24.2 g
-Fasting period before study: ca. 8 hours before administration, feeding resumed 2 hours after administration
-Housing: cages were made out of polyethylene with 5 animals in each cage
-Diet: ad libitum
-Water: ad libitum
-Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
-Temperature (°C): 23 +/- 3
-Humidity (%): 55 +/- 15
-Air changes (per hr): 12
-Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

Preparations were conducted immediately before use and the test item was suspended in 0.25% CMC solution. 2.5 and 7.5% (w/v) suspensions were prepared. When converted to a volume of 0.4 mL per 10 g of body weight, this is equivalent to 1000 and 3000 mg/kg, respectively.

Doses:

1000 and 3000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

Mortality: Checks were made once a day between days 1-8
Clinical observation: On day 1, observation of acute toxicity symptoms was continuously conducted, starting immediately after dosing for approximately 2 hours. Observation of clinical signs was also conducted on day 1 before administration and once a day between days 2-8.
Measurement of body weight: body weights of all animals were measured on days 1, 2, and 8

Statistics:

not further specified

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: no adverse effects

Gross pathology:

no adverse effects

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Based on the study results the oral LD50 for the test item was > 3000 mg/kg bw

Executive summary:

The test item was administered once orally to male ICR at dose levels of 1000 or 3000 mg/kg bw. This dosing caused no adverse effects and therefore the oral LD50 was > 3000 mg/kg bw.