Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From February 16 to March 8, 2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Source study has reliability 1.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Similar Substance 01 - AR018
IUPAC Name:
Similar Substance 01 - AR018
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Granja Cunicola San Bernardo S.L. (Tulebras, Navarra, Spain)
- Weight at study initiation: 2.6 - 3.1 kg
- Housing: individually in stainless steel cages(52 × 58 × 43 cm) with a grille floor and placed on a rack
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 -23 °C
- Humidity: 30 - 60 %
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 1 h

SCORING SYSTEM:
Cornea opacity:
0 no ulceration or opacity
1 scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 easily discernible translucent area, details of iris slightly obscured
3 nacreous area, no details of iris visible, size of pupil barely perceptible
4 opaque cornea, iris not discernible through the opacity

Iris:
0 normal
1 markedly deepend rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection (any of these or a combination thereof), iris still reacting to light (a sluggish reaction is positive)
2 no reaction to light, haemorrhage, gross destruction (any or all of these)

Conjunctivae redness:
0 blood vessels normal
1 some blood vessels definitely hyperaemic (injected)
2 diffuse, crimson clour, individual vessels not easily discernible
3 diffuse beefy red

Conjunctivae edema:
0 no swelling
1 slight swelling (includes nictitating membranes)
2 obvious swelling with partial eversion of lids
3 swelling with lids about half-closed
4 swelling with lids more than half-closed

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal: #1 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal: #2 and #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

animal region of eye 1 h 24 h 48 h 72 h 7 d
1 cornea opacity 0 0 0 0 0
iris 0 0 0 0 0
conjunctivae redness 2 1 1 0 0
conjunctivae edema 2 1 0 0 0
2 cornea opacity 0 1 1 0 0
iris 0 0 0 0 0
conjunctivae redness 2 2 1 1 0
conjunctivae edema 2 1 0 0 0
3 cornea opacity 0 0 0 0 0
iris 0 0 0 0 0
conjunctivae redness 2 2 1 1 0
conjunctivae edema 1 1 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritant to rabbit eye.
Executive summary:

Method

OECD guideline 405. 0.1 g of test substance was instilled in one eye of 3 rabbits; the other eye served as control. 1 hour after start of exposure, removal of residues with physiological saline was done. Observations were carried out 1, 24, 48, 72 hours after start up to 7 day; effects in terms of corneal opacitiy, iris, conjunctivae redness and chemosis were evaluated.

Results

Slight effects on corneal opacity were seen in 1/3 rabbit; effects on conjunctivae in terms of redness and chemosis were seen in 3/3 rabbits. All such effects were fully reversible within 7 days.