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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 september 2006 to 22 september 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): R0054002C, synonym IMEXINE OBH
- Physical state: beige to yellow powder
- Purity: 99.7%
- Impurities (identity and concentrations): not indicated
- Purity test date: 20 July 2006
- Lot/batch No.: R0054002C 013 L 001, synonym 0604070001
- Expiration date of the lot/batch: 01 August 2007
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature and under nitrogen gas

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Grimaud Frères, La Corbière, Roussay, France
- Age at study initiation: 2 to 4 months
- Weight at study initiation: 2.682 kg
- Housing: Pajon cages
- Diet (e.g. ad libitum): 110 pelleted diet
- Water (e.g. ad libitum): water filtered by FG Millipore membrane
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 30 to 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
not applicable (single instillation without rinsing)
Observation period (in vivo):
1 hour, 24, 48 and 72 hours
Number of animals or in vitro replicates:
One.
Details on study design:
A single dose of 100 mg of the test item in its original form was introduced into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball.

The lower and upper eyelids were held together for about one second to avoid any loss of test item. The right eye, which remained untreated,
served as control.

The eyes were not rinsed after administration of the test item.


SCORING SYSTEM:
Conjunctival lesions and discharge
Chemosis (lids and/or nictitating membranes)
. no swelling 0
. any swelling above normal (includes nictitating membranes) 1
. obvious swelling with partial eversion of lids 2
. swelling with lids about half-closed 3
. swelling with lids more than half-closed 4

Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
. blood vessels normal 0
. a number of blood vessels definitely hyperemic (injected) 1
. diffuse, crimson colour, individual vessels not easily discernible 2
. diffuse, beefy red 3

Discharge
. absence of discharge 0
. slight discharge (does not include small amounts normally found in
inner canthus) 1
. discharge with moistening of lids and hairs adjacent to lids 2
. discharge with moistening of lids and hairs on wide area around the eye 3

Iris lesions
. normal 0
. markedly deepened rugae, congestion, swelling, moderate circum-corneal
hyperemia, or injection, any of these or combination of any thereof, iris still
reacting to light (sluggish reaction is positive) 1
. no reaction to light, haemorrhage, gross destruction (any or all of these) 2

Corneal lesions
Degree of opacity (area most dense taken for reading)
. no ulceration or opacity 0
. scattered or diffuse areas of opacity (other than slight dulling or normal lustre),
details of iris clearly visible 1
. easily discernible translucent area, details of iris slightly obscured 2
. nacreous areas, no details of iris visible, size of pupil barely discernible 3
. opaque cornea, iris not discernible through the opacity 4

Area of opacity
. one quarter (or less) but not zero 1
. greater than one quarter but less than a half 2
. greater than one half but less than three quarters 3
. greater than three quarters up to whole area. 4


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 24, 48, 72
Score:
3
Max. score:
3
Reversibility:
other: animal sacrificed for ethical reasons
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72
Score:
2.3
Max. score:
3
Reversibility:
other: animal sacrificed for ethical reasons
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72
Score:
1
Max. score:
1
Reversibility:
other: animal sacrificed for ethical reason
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72
Score:
3.7
Max. score:
4
Reversibility:
other: animal sacrificed for ethical reasons
Irritant / corrosive response data:
Severe irritant effects were observed.
Other effects:
On days 3 and 4, the eyelids of the animal were stuck together. In order to assess the ocular lesions, the eyelids were unstuck with 0.9% NaCl.
Clear to whitish purulent discharge was noted from day 1 until day 4.

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was severely irritant when administered by ocular route to rabbits.