Registration Dossier
Registration Dossier
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EC number: 214-275-1 | CAS number: 1119-34-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-01-11 to 2012-04-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (+)-L-arginine hydrochloride
- EC Number:
- 214-275-1
- EC Name:
- (+)-L-arginine hydrochloride
- Cas Number:
- 1119-34-2
- Molecular formula:
- C6H14N4O2.ClH
- IUPAC Name:
- (2S)-2-amino-5-carbamimidamidopentanoic acid hydrochloride
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, Branch Löhndorf, D-24601 Löhndorf/Post Wankendorf
- Age at study initiation: Approx. 6.5 to 8.5 months at dosing
- Weight at study initiation: 2.4 kg, 2.5 kg. 2.7 kg
- Housing: During the acclimatisation period and after the 8-hour period in restrainers after application, the animals were kept singly in cages with dimensions of 380 mm x 425 mm x 600 mm (manufacturer: Dipl.Ing. W. EHRET GmbH, 16352 Schönwalde, Germany).
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
According to guideline
IN-LIFE DATES: From: 2012-01-24 To: 2012-02-17
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- 1 hour.
- Observation period (in vivo):
- 1 h, 24 h, 48 h, 72 h.
- Number of animals or in vitro replicates:
- Total of 3. In accordance with the guideline the test was performed initially using one animal. As no corrosive or severe irritant effects were observed in this animal, 2 further animals were employed 24 hours after start of the initial test.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were rinsed with portions of 20 mL 0.9% aqueous NaCl solution, each.
- Time after start of exposure: 1 h.
SCORING SYSTEM:
- Cornea score: Opacity - degree of density (area most dense taken for reading)
- Iris score
- Conjunctivae score, redness: Refers to palpebral and bulbar conjunctivae, excluding cornea and iris
- Chemosis score: Swelling - refers to lids and/or nictitating membranes
TOOL USED TO ASSESS SCORE: Hand-slit lamp. 24 h after administration, fluorescein was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 h, 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Score for each animal was 0 at any observation time.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 h, 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: Score for each animal was 0 at any observation time.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: Score for each animal was 1 after 1 h.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: Score for each animal was 0 after 24 h, 48 h and 72 h.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 h, 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Score for each animal was 0 at any observation time.
- Other effects:
- No pathological findings with the fluorescin test after 24 h.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- L-arginine-HCl did not show eye irritating properties in an in in vivo GLP guideline study according to OECD 405.
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