Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 02 May 2000 to 05 May 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline Study & Test in accordance with National procedures (OPPTS)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance type: pure active substance
- Analytical purity: 98.5 %
- isomers compositions: ca. 10-12% cis- and 88-90 % trans- isomers
- Lot/batch No.: F84912-08D
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, South Brunswick, NJ - USA
- Age at study initiation: adult
- Weight at study initiation: not mentionned in study report
- Housing: suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guidefor the Care and Use of Laboratory Animals DHEW (NlH). Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Free access (Pelleted Purina Rabbit Chow #5326)
- Water (e.g. ad libitum): Free access (Filtered tap water was supplied by automatic water dispensing system)
- Acclimation period: six days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 38 to 43%
- Air changes (per hr): not mentionned in the study report
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 02 May 2000 To: 05 May 2000

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye (left eye)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
72 hours
(0.1 ml of the test substance, as received, was instilled into the conjunctival sac of the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing, to minimize loss of the test substance. The other eye of each rabbit remained untreated with the test substance and served as a control. The rabbits were then returned to their designated cages. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment).
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. An assessment of the initial pain reaction was made immediately after administration of the test material.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: NA

SCORING SYSTEM: see "Attached background material"

TOOL USED TO ASSESS SCORE: Ocular irritation was evaluated using a high-intensity white light (Mag Lite) in accordance with Draize et al. at 1, 24, 48 and 72 hours post-instillation. The fluorescein dye evaluation procedure was used at 24 hours to verify the absence of corneal damage (see below). Individual scores were recorded for each animal. In addition to observations of the cornea, iris and conjunctivae, any other observed lesions were noted.
Prior to instillation, both eyes of a number of animals were examined using a fluorescein dye procedure. One drop of 2% ophthalmic fluorescein sodium was instilled into both eyes ofeach rabbit. The eyes were rinsed with physiological saline (0.9% NaCl) approximately 30 seconds after instillation of the fluorescein. Using a Blak-Ray® Lamp (compact 4-watt UV Lamp), the eyes were checked for gross abnormalities according to the "Scale for Scoring Ocular Lesions". Only healthy animals without pre-existing ocular irritation were selected for test.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: # 1, 2, & 3
Time point:
other: 1, 24, 48 & 72 h
Score:
0
Max. score:
4
Reversibility:
other: No changes were recorded
Irritation parameter:
iris score
Basis:
animal: # 1, 2 & 3
Time point:
other: 1, 24, 48 & 72 h
Score:
0
Max. score:
2
Reversibility:
other: No changes were recorded
Irritation parameter:
chemosis score
Basis:
animal: # 1 & 2
Time point:
other: 1h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal: # 1, 2 & 3
Time point:
other: 1h & 24h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1, 24, 48 & 72 hours
Score:
6.7
Max. score:
110
Reversibility:
fully reversible within: 48h
Irritant / corrosive response data:
See above block of fields "Overall Irritation/corrosion results"
Other effects:
None.
All animals appeared active and healthy. Apart from the eye irritation noted below, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior. No corneal opacity or iritis was noted during the study. One hour after test substance instillation, all three treated eyes exhibited conjunctivitis. The incidence and severity of irritation decreased with time. All animals were free of ocular irritation within 48 hours.

Any other information on results incl. tables

Individual scores for ocular irritation are given in "Results and discussions". The individual mean scores as required for the EU-labelling regulations are presented in the following table:

Rabbit Number

Time after treatment (h)

Corneal Opacity

IridialInflammation

ConjunctivalRedness

CunjunctivalChemosis

1 Male

24

48

72

0

0

0

0

0

0

0

0

0

0

0

0

Total

0

0

0

0

Mean

0.0

0.0

0

0

2 Male

24

48

72

0

0

0

0

0

0

1

0

0

0

0

0

Total

0

0

1

0

Mean

0.0

0.0

0.3

0

3 Male

24

48

72

0

0

0

0

0

0

1

0

0

0

0

0

Total

0

0

1

0

Mean

0.0

0.0

0.3

0.0

 

All treated eyes appeared normal at the 72-hour observation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material does not meet the criteria for classification as irritant according to EU labeling regulations Commission Directive 2001/59/EC.
Executive summary:

The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the OECD Guideline No. 405 “Acute Eye Irritation/Corrosion” (2002) and of the Health Effects Test Guidelines, OPPTS 870.2400 (1998).

0.1 ml of the test substance, as received, was instilled into the right eye of three healthy rabbits. The left eye remained untreated and served as a control. Ocular irritation was evaluated by the method of Draize. No corneal opacity or iritis was noted during the study. One hour after test substance instillation, all three treated eyes exhibited conjunctivitis. The incidence and severity of irritation decreased with time. All animals were free of ocular irritation within 48 hours.

 

The test material does not meet the criteria for classification as irritant according to EU labeling regulations Commission Directive 2001/59/EC.