Lysine hydrochloride

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 2002 - February 2003

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: one experiment was conducted with 14-15 week old rats

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

and directive 92/69/EEC

Deviations:

yes

Remarks:

one experiment was conducted with 14-15 week old rats

Principles of method if other than guideline:

two experiments were performed because the limit concentration of at least 5 g/m3 was not reached in first experiment

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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): LYS HCL crystals
- Substance type: solid
- Physical state: pale yellow crystals
- Analytical purity: 100%
- Lot/batch No.: CP trial 13-14 November 2001
- Expiration date of the lot/batch: 1 November 2004
- Storage condition of test material: ambient temberature, under dry conditions

Test animals

Species:

rat

Strain:

other: Wistar Crl[WI]WU BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (Sulzfeld, Germany)
- Age at study initiation: 6-7 weeks at 4.98 g/m3 and 14-15 weeks at 5.51 g/m3
- Weight at study initiation: mean weights of 182 and 148 g for males and females, respectively at 4.98 g/m3 and of 349 and 201g for males and females, respectively at 5.51 g/m3
- Fasting period before study: no…
- Housing: individually in the holders during exposure
- Diet (e.g. ad libitum): no access to food during exposure, ad libitum before and after exposure
- Water (e.g. ad libitum): no access to water during exposure, ad libitum before and after exposure
- Acclimation period: 6 days at 4.98 g/m3 and 60 days at 5.51 g/m3

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): ~ 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 27 November 2002 To: 10 February, 2010

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: aerosol generated with ambient air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: nose-only inhalation chamber
- Exposure chamber volume: 50 L…
- Method of holding animals in test chamber: plastic animal holders
- Source and rate of air: ambient air flowing through the exposure unit at a mean rate of 114.9 L/minute
- Method of conditioning air: the test material was delivered in a slip stream of ambient air
- System of generating aerosols: the test atmosphere was generated by passing the milled test material to an eductor placed at the inlet of the exposure unit and operated with pressurized humidified air controlled by a pressure reducing valve at 1.5 bar. The air flow of the eductor was established to be 114.9 L/minute at 1.5 bar
- Method of particle size determination: 10-stage cascade impactor
- Treatment of exhaust air: exhaust to filter
- Temperature, humidity, pressure in air chamber: 20.6±0.4 ◦C , humidity 31-57% and oxygen 21.6% at 4.98 g/m3, and 21.7±0.2 ◦C, humidity 30-36% and oxgen at 21.1% at 4.98 g/m3. Pressure 1.5 bar

TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric analysis once per hour
- Samples taken from breathing zone: yes

VEHICLE
- Composition of vehicle (if applicable): not applicable
- Concentration of test material in vehicle (if applicable): not applicable
- Justification of choice of vehicle: not applicable
- Lot/batch no.: not indicated (test compound)
- Purity: 100% (test compound)

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 88% ≤ 8.0 µm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 3.3 - 3.4 µm / 2.3 -2.5µm

CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: limit concentration

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4

Remarks on duration:

none

Concentrations:

4.98 and 5.51 g/m3

No. of animals per sex per dose:

5 males & 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: visually inspected just before exposure, during exposure, shortly after exposure, and at least once daily during the observation period. Bodyweights were recorded on days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: examined for gross pathological changes

Statistics:

no

Results and discussion

Preliminary study:

no

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.51 other: g/m³

Exp. duration:

4 h

Remarks on result:

other: none

Mortality:

no

Clinical signs:

other: decreased breathing rate during exposure, irregular or shallow breathing, nasal encrustations, soiled fur, cold to touch and piloerection shortly after exposure, no abnormalities after day 1.

Body weight:

as expected for animals of this strain and age

Gross pathology:

no treatment-related findings

Other findings:

- Organ weights: not applicable
- Histopathology: not applicable
- Potential target organs: not applicable
- Other observations: none

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: EU

Conclusions:

L-lysine HCl is practically nontoxic when inhaled.