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Toxicological information

Skin irritation / corrosion

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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:
2002
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

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): 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

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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