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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1994-12-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand Albino, Chbb: NZW (SPF)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3-5 month
- Weight at study initiation: 3.3 kg
- Housing: single housing
- Diet: ad libitum, laboratory rabbit diet Altromin 2123 and in addition hay (15 g daily)
- Water: ad libitum, tap water
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light


Test system

Vehicle:
water
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of test item
- Concentration: applied as delivered by the sponsor (99.4% dry solids)

Duration of treatment / exposure:
eye was not rinsed after treatment
Observation period (in vivo):
1 h
Number of animals or in vitro replicates:
1
Details on study design:
PREPARATION OF ANIMALS
- 24 h before treatment the eye to be treated was examined for corneal lesions under UV light after application of one drop of fluorescein-sodium solution (0.01%)

APPLICATION OF TEST SUBSTANCE
- 100 mg test substance was instilled into the conjunctival sac of the left eye. The untreated right eye served as control.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not rinsed after treatment

SCORING SYSTEM: according OECD 405 (Draize scheme)

Results and discussion

In vivo

Results
Irritation parameter:
other: irreversible effects to the eye
Basis:
animal #1
Time point:
other: 1h
Reversibility:
other: animal was humanely killed because of severity of effects after the first scoring one hour after treatment
Remarks on result:
other: extreme bleeding of conjunctivae and nictating membrane, blood coloured discharge, reddened iris, cornea opacity score 2 of one half of the cornea, iritis score 1, conjunctival erythema and chemosis score 3
Irritant / corrosive response data:
1 h after dosing: extreme bleeding of conjunctivae and nictating membrane, blood coloured discharge, reddened iris, cornea opacity score 2 of one half of the cornea, iritis score 1, conjunctival erythema and chemosis score 3. The untreated control eye showed no abnormalities.
After this scoring the animals was humanely killed because of the severity of effects.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for one animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea,

- opacity -

Cornea

- area-

Iris

Conjunctivae

Chemosis

Discharge

Max. score 4

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

Max. score: 3

1 h

2

2

1

3

3

2

In addition extreme bleeding of conjunctivae and nictating membrane, blood coloured discharge, reddened iris.

After the 1 h scoring the animals was humanely killed because of the severity of effects.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information spray dried, 99.4% a.i. Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
Classification is based on effects on the cornea, iris and conjunctiva calculated following grading at 24 hours after instillation of the test material, in consideration of reversibility.
The test substance is considered to cause irreversible effects to the eye according to CLP, EU GHS (Regulation (EC) No 1272/2008).
Executive summary:

In a primary eye irritation study according to EU Method B.5 (1992) and OECD Guideline 405 (1987), 100 mg of Coco AAPB (99.4 % dry solids) was instilled into the conjunctival sac of one New Zealand white rabbit. The eye was not rinsed after test substance instillation. After the first scoring one hour after test substance instillation, the test was terminated. Irritation was scored according to Draize as stipulated in the guidelines.

The treated eye showed 1 h after dosing extreme bleeding of conjunctivae and nictating membrane, blood coloured discharge, reddened iris, cornea opacity score 2 of one half of the cornea, iritis score 1, conjunctival erytheme and chemosis score 3. The untreated control eye showed no abnormalities.

After this scoring the animals was humanely killed because of severity of effects.

In this study, Coco AAPB (99.4 % dry solids) caused irreversible effects on the eye.