N6-(1-oxododecyl)-L-lysine

Endpoint summary

Description of key information

The test item was administered once orally to male ICR mice 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.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

Specific details on test material used for the study:

not further specified

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

3 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In an acute oral toxicity study with ICR mice the dosing with up to 3000 mg/kg bw caused no adverse effects, i.e. the oral LD50 value of the test item is > 3000 mg/kg bw. A Draize test comparable to OECD Guideline 404 gave no indication for adverse systemic effects and there was also no indication for a skin irritating potential of the test item. Also in a GPMT comparable to OECD Guideline 406 the test item caused no adverse effects and gave no indication for a skin sensitisation potential.

Therefore, due to animal welfare a further testing with dermal exposure at present is not adequate.

A direct exposure of humans via inhalation is not likely, as the vapour pressure of the test item is very low and, in addition, the test item itself is formulated into different products.

Therefore, due to animal welfare a further testing with exposure via inhalation is not adequate.

Justification for classification or non-classification

In a study with oral dosing of ICR mice, a LD50 value of > 3000 mg/kg was obtained. Therefore, there is no need for classification and labelling of the test item according to CLP Regulation 1272/2008/EG.