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Toxicological information

Eye irritation

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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:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
L-arginine-HCl did not show eye irritating properties in an in in vivo GLP guideline study according to OECD 405.