Lysine hydrochloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study dates from 1971, although not meeting the current acute toxicity guidelines and GLP requirements and lacking described details, the study reveals usefull data considering the LD50 in rats.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

no guideline available

Guideline:

other: the study dated from 1971, no guidelines available then

Principles of method if other than guideline:

Two male and two female rats were administered 0 - 16 g/kg of L-lysine HCl and observed during two weeks for mortality. Subsequently 5 male and 5 female rats were administered 0, 8.0, 10.0, 12.5, and 16.0 g/kg of L-Lysine HCl and observed during two weeks for mortality.

GLP compliance:

not specified

Test type:

other: divided doses at 2 h intervals

Test material

Test material information

Constituent 1

Reference substance name:

Lysine hydrochloride

EC Number:

211-519-9

EC Name:

Lysine hydrochloride

Cas Number:

657-27-2

Molecular formula:

C6H14N2O2.ClH

IUPAC Name:

lysine hydrochloride

Details on test material:

- Name of test material (as cited in study report): L-Lysine HCl
- Lot/batch No.: 35792
- Other: no further details described

Test animals

Species:

rat

Strain:

other: CFY strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Carworth Europe, Huntingdon
- Age at study initiation: Not reported
- Weight at study initiation: 62 - 123 g
- Fasting period before study: 20 hours before dosing and 4 hours after dosing
- Housing: caged in groups according to sex and age
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
Not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: water or methyl cellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30% solution in water or suspension
No further details reported

Doses:

Test 1: 0, 4, 8, 16 g/kg
Test 2: 0, 8.0, 10.0, 12.5, 16.0 g/kg

No. of animals per sex per dose:

Test 1: 2 males and 2 females
Test 2: 5 males and 5 females

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once a week
- Necropsy of survivors performed: yes
- Other examinations performed: body weight/behaviour

Statistics:

Method of Litchfield J.T., Wilcoxon F (1949), J. Pharmac. exp. Ther. 96, 99

Results and discussion

Preliminary study:

The results of the preliminary range finding indicated that the median lethal dose LD50 was in the range of 8000 - 16000 mg/kg modyweight

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 8 000 - <= 16 000 mg/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 10 600 mg/kg bw

95% CL:

>= 9 500 - <= 11 900

Mortality:

Mortality occured 22 hours after dosing

Clinical signs:

other: Lethargy, diarrhoea, diuresis, atony

Gross pathology:

Congestion in kidney cortices upon death

Other findings:

- Potential target organs: kidney cortices

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: not specified

Conclusions:

Data in 5 male and 5 female rats show that the median lethal oral dose (LD50) of L-lysine HCl was calculated 10600 (9500 - 11900) mg/kg bw