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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:
15-04-2013 to 25-04-2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study according to the guidelines under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: extremely viscous liquid
Details on test material:
- Name of test material (as cited in study report): Fatty acids, tall oil, reaction products with fatty acids C16-18 and C18-unsatd, branched and linear, diethylenetriamine and methylhydrogen maleate
- Substance type: UVCB
- Physical state: extremely viscous liquid
- Storage condition of test material: room temperature in dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12 to 20 weeks
- Weight at study initiation: 2.50 to 2.71 kg
- Housing: individually
- Diet: ad libitum (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon)
- Water; ad libitum
- Acclimation period: minimal 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): ≥15/hr
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL applied to the conjunctival sac of the right eye
Observation period (in vivo):
1, 24, 48 and 72 hour observations
Number of animals or in vitro replicates:
2
Details on study design:
ANAESTHETICS AND ANALGESICS
– doses and times when topical anaesthetics and systemic analgesics were administered:
systemic: buprenorphine 0.01 mg/kg sc 60 minutes prior to dosing
local: 0.5% tetracaine hydrochloride (2 drops ineach eye) 5 minutes prior to dosing
systemic: buprenorphine 0.01 mg/kg sc and meloxicam 0.5 mg/kg sc 8 hours after dosing
- interaction with test substance: none reported
- inititial pain score: not reported

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: standard ophthalmoscope (no fluorescein used)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: average 24-72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: average 24-72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: avarage 24-72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: average 24-72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
not irritant
Other effects:
No effects on body weight

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test substance is not irritating to the eyes
Executive summary:

In an in vivo test two rabbits were treated with the test substance (0.1 mL applied in the conjunctival sac of one eye) after systemic and local analgesia/anaesthesia . No signs of irritatiion except for very slight effects on the conjunctivae after 1, 24 and 48 hours became apparent. After 72 hours no effects were noted. Therefore it is concluded that the test substance is not irritating to the eyes.