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Diss Factsheets

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

Constituent 1
Chemical structure
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.