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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:
April 1996 - May 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Information on substance identity and composition is lacking. Batch No. is given, guideline 405 is followed and study is performed according to GLP. Statement from company owner is received on substance identity and composition mentioned in study report. Based on this the reliability turned into 2. If substance identity and composition was reported in study report then reliability would turn into 1.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
- age of animals is not mentioned
- no initial and confirmatory test (however, no severe effects were anticipated)
GLP compliance:
yes

Test material

Constituent 1
Test material form:
liquid
Details on test material:
- physical state: colourless liquid
date of receipt: 14.11.95
storage conditions: at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, France
- Age at study initiation: no info
- Weight at study initiation: on the day of treatment 2.3 ± 0.1 kg
- Housing: Individual housing
- Diet (e.g. ad libitum): free access to pelleted diet
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12h/12h


IN-LIFE DATES: From: April 25, 1996 To: May 16, 1996

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 into the left eye
- Concentration (if solution): test article was used in its original form


VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable
Duration of treatment / exposure:
single application into the left eye: the lower and upper eyelids were held together for about one second to avoid any loss of test substance.
Observation period (in vivo):
- approximately 1 hour and 24, 48 and 72 hours after administration
- when there is persistent ocular irritation after 72 hours the observation period is extended to a maximum of 21 days (until day 22)
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eyes were not rinsed
- Time after start of exposure: not applicable


SCORING SYSTEM: see below


TOOL USED TO ASSESS SCORE:
- Cornea: 2 drops of 0.5% sodium fluorescein solution; direct examination or, if necessary, with an Ultra-Violet lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Remarks on result:
probability of mild irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 6 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 5 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
probability of mild irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Remarks on result:
probability of mild irritation
Irritant / corrosive response data:
No ocular corrosion mentioned.
Other effects:
Conjunctival reactions in all animals form day 1 up to days 4,5 and 6. Accompanied by clear or purulent ocular discharge for 24 to 78 hours. No other ocular reactions.

Any other information on results incl. tables

Summary of ocular lesions

Animal No. Effect Hours Days after application Mean score Chemosis Days 1/2/3 Mean score Redness Days 1/2/3 Mean score Iris Days 1/2/3 Mean score Cornea Days 1/2/3
1 1 2 3 4 5 6
1 Chemosis 2 1 1 0 0 - - 0.7
Redness 0 1 1 1 0 - - 1
Iris 0 0 0 0 0 - - 0
Cornea 0 0 0 0 0 - - 0
2 Chemosis 1 1 1 0 0 0 0 0.7
Redness 0 2 2 2 2 1 0 2
Iris 0 0 0 0 0 0 0 0
Cornea 0 0 0 0 0 0 0 0
3 Chemosis 2 1 1 1 0 0 - 1
Redness 0 2 2 2 1 0 - 2
Iris 0 0 0 0 0 0 - 0
Cornea 0 0 0 0 0 0 - 0
Mean all animals 0.8 1.7 0 0

- Ocular examination not performed

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 "Irritating to eyes" Category 2 according to the Annex VI of the Regulation (C) No. 1272/2008 (CLP) and as mild-irritant to the eyes (Cat. 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 (Aqualenc F) was instilled into the left conjunctival sac of 3 male New Zealand White rabbits while the right eye served as control. The eyes were not rinsed after the instillation of test material. Animals were observed at 1, 24, 48 and 72 after instillation and then daily for 3 days. The reactions in the conjunctivae (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize Scale.

The calculated mean score for each individual lesion for all the animals within 3 scoring times (24, 48 and 72 h) were: 1.7 for redness, 0.8 for chemosis, 0.0 for iris lesions and corneal opacity.

The calculated mean score for each individual lesion for each individual animal within 3 scoring times (24, 48 and 72 hrs) were as follows: 0.7 / 0.7 / 1.00 for chemosis, 1.00 / 2.00 / 2.00 for redness, and 0.0 / 0.0 / 0.0 for iris lesions and for corneal opacity.

Very slight to slight conjunctival reactions were observed in all animals from day 1 up to days 4, 5 or 6. They were accompanied by a clear or purulent ocular discharge for 24 to 48 hours. No other ocular reactions were recorded.

Under the test conditions, the test material is classified as H319 "irritating to the eyes" Category 2 according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and as mild-irritant to the eyes (Cat. 2B) according to the GHS.

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