Registration Dossier

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:
from 26th May 1997 to 9th June 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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: B & K UNIVERSAL G.J., S.L. (Sant Vincenç; dels Horts, Barcelona, Spain) on 12th May 1997 (no. 954, 958 and 972)
- Age at study initiation: 9-10 weeks.
- Weight at study initiation: 2.1-2.6 kg
- Housing: housed individually in stainless steel cages (48 x 59 x 37 cm), with a grille floor, placed on racks.
- Diet: The animals were allowed free access to a standard rabbit diet UAR 112
- Water: water was supplied ad libitum by an automatic drinking system.
- Acclimation period: 7 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 23 °C
- Humidity: 40 - 85 %
- Photoperiod: 12 hours cycle dark/light (7:00 to 19:00)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
- Amount applied: 100 mg
Observation period (in vivo):
at 1, 24, 48 and 72 hours and 7, 14 days
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes, washing the area with a 0.9% physiological saline solution.

ASSESSMENT OF EYE INJURIES
The ocular reactions observed in the cornea, iris and conjunctivae were assessed according to the classification, as outlined in the OECD GUIDELINE FOR TESTING OF CHEMICALS, No. 405, of 24th February 1997

TOOL USED TO ASSESS SCORE: 2% aqueous sodium fluorescein solution

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: rinsed eye
Irritation parameter:
iris score
Basis:
animal: #1, 2#, #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: rinsed eye
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: #1, 2#, #3
Time point:
24/48/72 h
Score:
1.33
Reversibility:
fully reversible within: 7 d (#2) and 14 d (#1, #3)
Remarks on result:
other: rinsed eye
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: rinsed eye
Irritation parameter:
chemosis score
Basis:
animal: #2, #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: rinsed eye
Other effects:
Clinical signs:
the behaviour and physical condition of the rabbits were normal throughout the study.

Any other information on results incl. tables

In the course of the first hour after administration, the test substance induced in the palpebral and bulbar conjunctivae of all the animals, diffuse crimson redness with individual vessels difficult to discern (grade 2) accompanied by swelling with lids nearly or completely closed (grade 4) in two animals and swelling with lids approximately half closed (grade 3) in the remaining animal. All the animals also presented lacrimation, with wetness of the eyelids and nearby hair in one animal and wetness ofthe eyelids and nearby hair, affecting a considerable area in the remaining animals.

One of the animals presented corneal opacity (grade 1). In the readings performed at 24 hours from treatment, all the animals presented diffiuse crimson redness in the conjuncttvae with individual vessels difficult to discern (grade 2) accompanied by some above-normal swelling (grade 1) in one ofthe animals. In the observations perforned at 2 and 3 days from treatment all the animals presented some clearly hyperaemic blood vessels (injected) (grade 1). In the reading made after 7 days, two of the three animals continued to show some clearly hyperaemic blood vessels (injected) (grade 1). In the observations performed 14 days after treatment, the said alterations had totally disappeared.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC) no. 1272/2008
Conclusions:
The substance was found not to be irritant to the rabbit eye.
Executive summary:

The test substance was tested in order to evaluate the primary eye irritation, according to the OECD Guideline No. 405 (1987) and to the method B.5 of the EEC Directive of 31st July 1992 (92/69/EEC).

The mean values (24/48/72 h) for corneal opacity and iris scores were 0 in all animals; for conjunctivae redness were 1.33 all animals. The mean scores for conjunctivae edema were 0.33 in one animal (#1) and 0 the other two animals (#2 and #3). In the observations performed at 14 days after treatment, the said alterations were observed to be reversible.