Registration Dossier
Registration Dossier
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EC number: 211-519-9 | CAS number: 657-27-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 18 - 21, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study is performed according OECD Guideline 404 and EU method B.4 under GLP conditions. No deviations reported.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- 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): Lysine HCl crystals
- Substance type: white to yellow crystals
- Physical state: solid
- Analytical purity: 99%
- Lot/batch No.: CP trial 13-14 November 2001
- Expiration date of the lot/batch: 01-11-2004
- Storage condition of test material: ambient temperature, under dry conditions
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Centro Lagro, France
- Age at study initiation: ca. 9 weeks
- Weight at study initiation: ca. 1800 g
- Housing: individually in stainless steel cages with perforated floor
- Diet (e.g. ad libitum): standard laboratory diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.25 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: diameter ± 2.5 cm
- Type of wrap if used: adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): tissue moistened with water
- Time after start of exposure: 1 hour
SCORING SYSTEM:
EVALUATION OF SKIN REACTIONS (DRAIZE ET AL., 1944)
A. Erythema and eschar formation Value
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate erythema 3
Severe erythema (beet redness); eschar formation
(injuries in depth: ischemic necrosis, haemorrhages, and incrustation) 4
B. Oedema formation
No oedema o
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimeter) 3
Severe oedema (raised more than 1 millimeter, extending) 4
Tools used to assess score: not described.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no erythema induced
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no edema induced
- Irritant / corrosive response data:
- Lysine HCl crystals did not induce any erythema or edema in three albino rabbits.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Lysine HCl crystals tested on three albino rabbits according to OECD Guideline 404 and EU method B.4 under GLP conditions did not cause any skin effect during 72 hours evaluation.
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