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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:
02/08/1991-28/11/1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
According to the OECD Guideline and in compliance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

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
Test material form:
liquid
Details on test material:
- Physical state: clear yellow liquid
- Storage conditions: between 20-30°C in the dark
- Stability under test conditions: stable

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 73 weeks
- Weight at study initiation: 2214-2789 g
- Housing: Individually in labelled cages, with perforated floors and equipped with an automatic drinking system.
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands), approx.100 gram per day.
- Water (e.g. ad libitum): free access to tap water diluted with decalcified water.
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
7 days
Observation period (in vivo):
1, 24, 48 and 72 hours and 7 days after instillation of test material
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not reported

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Instillation of the test substance into one eye of each of three female albino rabbits affected the iris and conjunctivae of all three animals. The injection of the iris had resolved within 24 hours and the irritation of the conjunctivae had resolved within 7 days in all three animals.
Treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.
There was no evidence of ocular corrosion.
Other effects:
No toxic symptoms were observed in the animals during the test period and no mortality occured.

Any other information on results incl. tables

Individual findings:

Animal No. 736
Time after instillation Tissue Score Fluor. Area % Comments
1 hour Corneal opacity 0 Redness grade 2 for scleral conjunctivae.
Chemosis grade 2 for nictating membrane.
Lacrimation was observed.
area 0
Iris 1
Conj. Redness 2
chemosis 2
Discharge 1
24 hours Corneal opacity 0 0
area 0
Iris 0
Conj. Redness 2
chemosis 1
Discharge 1
48 hours Corneal opacity 0 Chemosis grade 1 for nictating membrane.
area 0
Iris 0
Conj. Redness 2
chemosis 1
Discharge 1
72 hours Corneal opacity 0
area 0
Iris 0
Conj. Redness 1
chemosis 0
Discharge 0
7 days Corneal opacity 0
area 0
Iris 0
Conj. Redness 0
chemosis 0
Discharge 0
Animal No. 737
Time after instillation Tissue Score Fluor. Area % Comments
1 hour Corneal opacity 0 Lacrimation was observed.
area 0
Iris 1
Conj. Redness 1
chemosis 2
Discharge 1
24 hours Corneal opacity 0 0 Lacrimation was observed.
area 0
Iris 0
Conj. Redness 2
chemosis 1
Discharge 1
48 hours Corneal opacity 0 Chemosis grade 1 for nictating membrane.
area 0
Iris 0
Conj. Redness 2
chemosis 1
Discharge 1
72 hours Corneal opacity 0 Redness grade 2 for scleral conjunctivae.
area 0
Iris 0
Conj. Redness 2
chemosis 0
Discharge 0
7 days Corneal opacity 0
area 0
Iris 0
Conj. Redness 0
chemosis 0
Discharge 0
Animal No. 738
Time after instillation Tissue Score Fluor. Area % Comments
1 hour Corneal opacity 0 Redness grade 2 for scleral conjunctivae.
Lacrimation was observed.
area 0
Iris 1
Conj. Redness 2
chemosis 2
Discharge 1
24 hours Corneal opacity 0 0 Lacrimation was observed.
area 0
Iris 0
Conj. Redness 2
chemosis 1
Discharge 1
48 hours Corneal opacity 0 Lacrimation was observed.
area 0
Iris 0
Conj. Redness 2
chemosis 1
Discharge 2
72 hours Corneal opacity 0 Redness grade 2 for scleral conjunctivae.
area 0
Iris 0
Conj. Redness 2
chemosis 1
Discharge 1
7 days Corneal opacity 0
area 0
Iris 0
Conj. Redness 0
chemosis 0
Discharge 0

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
Under the test conditions, the test material is classified as H319 "Causes serious eye irritation" Category 2 according to the Regulation (EC) No. 1272/2008 (CLP) and Category 2B according to the GHS.
Executive summary:

In an eye irritation study performed according to the OECD Guideline No. 405, and in compliance with GLP, 0.1 mL of undiluted test material was instilled into one eye of 3 female New Zealand White rabbits following a sequential testing strategy. The other eye remained untreated and served as control. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test material, and then released. The eyes were examined and the changes were observed at 1, 24, 48, 72 h and 7 days after treatment and graded according to the Draize method.

Instillation of the test substance into one eye of each of three female albino rabbits affected the iris and conjunctivae of all three animals. The injection of the iris had resolved within 24 hours and the irritation of the conjunctivae had resolved within 7 days in all three animals.

Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0 / 0 / 0 for cornea score; 0 / 0 / 0 for iris score; 1.7 / 2.0 / 2.0 for conjunctivae score and 0.7 / 0.7 / 1.0 for chemosis score.

Under the test conditions, the test material is classified as H319 "Causes serious eye irritation" Category 2 according to the Regulation (EC) No. 1272/2008 (CLP) and Category 2B according to the GHS.

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.

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