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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2011-12-08 to 2011-12-18
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across of a GLP guideline study RL1

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)
Version / remarks:
adopted April 24, 2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
2008
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
signed 2009-11-12

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

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, 24601 Löhndorf/Post Wankendorf, Germany
- Age at study initiation: approx. 4.5- 5.5 months
- Weight at study initiation: 2.5 - 2.8 kg
- Housing: animals were kept singly in cages of 380 mm x 425mm x 600 mm (manufacturer: Dipl. Ing. W. EHRET GmbH, 16352 Schönwalde, Germany) during the acclimatisation period and after the 8 hours period in restrainers (for 8 hours following test item application the animals were kept singly in restrainers).
- Diet (ad libitum): commercial diet, ssniff K-H V2333 (Ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (ad libitum before and after the exposure period): tap water
- Acclimation period: at least 20 adaptation days

ENVIRONMENTAL CONDITIONS:
- Temperature: 20°C ± 3°C (maximum range)
- Relative humidity: 30% to 70 % (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL:
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
1 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
INITIAL AND CONFORMATORY TEST
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.

The test item were administered into one eye each of three animals. The test item was placed into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control.

APPLICATION
- 100 mg of the test item were administered into one eye each of three animals. The volume of particulates was measured after gently compacting them, e.g. by tapping the measuring container. The test item was placed into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control.

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 hour after administration

SCORING SYSTEM: according to the Draize scale
Any further lesions are listed.

TOOL USED TO ASSESS SCORE: the eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48 and 72 hours after the administration. The eye reactions were observed and registered.
24 hours and after administration, fluorescein (Fluorescein SE Thilo drops (ALCON PHARMA GmbH, 79108 Freiburg, Germany) was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions.

OBSERVATIONS
Body weight of all animals was measured at the beginning of the study. Behaviour and food consumption were monitored.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: #1, #2
Time point:
other: mean 24, 48, 72 hours
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
other: mean 24, 48, 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24, 48, 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
Conjunctival redness (grade 1) was observed in all animals for 60 minutes, and in one animal for 24 hours after the instillation.
The corneae and irises were not affected by instillation of the test item.
The fluorescein test performed 24 hours after instillation did not reveal any changes.
Other effects:
There were no systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is non-irritating to the eyes.
According to 67/548/EC and subsequent regulations, the substance is not classified as an eye irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the substance is not classified as an eye irritant.