Registration Dossier

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:
2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study, for read-across justification refer to IUCLID section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

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
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japan/MAFF 8147
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
refer to confidential details on test material

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories, Netherlands
- Age at study initiation: Approx. 3 months
- Weight at study initiation: 2.27 kg – 2.51 kg
- Housing: Single housing, Stainless steel wire mesh cages with grating with shallow cage body; floor area: 4225 cm2
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

IN-LIFE DATES: From: 22 April 2014 To: 09 May 2014

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eyes of same animals used as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): unchanged

Duration of treatment / exposure:
24h
Observation period (in vivo):
96h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 24h with warm tap water
- Time after start of exposure: 24h

SCORING SYSTEM: see "any other information on material and methods incl. tables"

TOOL USED TO ASSESS SCORE: hand-slit lamp, otoscope lamp, fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h - 72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h - 72h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24h - 72h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritation parameter:
other: discharge
Basis:
mean
Time point:
other: 24h - 72h
Max. score:
3
Reversibility:
fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h - 72h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24h

Any other information on results incl. tables

No reactions on cornea or iris were observed in any animal during the observation period. Even after installation of fluorescein after 24 and 48 hours no corneal lesions were detectable. Slight conjunctival redness (grade 1) was noted in two animals at 1 hour after application. Slight conjunctival chemosis (grade 1) was noted in one animal at 1 hour after application. Severe discharge (grade 3) was noted in all animals at 1 hour after application. Additional findings like injected scleral vessels in a circumscribed area were noted at hour 1 after application only. The ocular reactions were reversible in all animals within 24 hours after application. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity, 0.0, 0.0 and 0.0 for iris lesions, 0.0, 0.0 and 0.0 for redness of the conjunctiva and 0.0, 0.0 and 0.0 for chemosis.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU