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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:
20 to 27 December 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): EDDS acid (under code)
- Substance type: technical product
- Physical state: white solid
- Stability under test conditions: no data
- Storage condition of test material: room temperature, in darkness

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2-3.5 kg
- Housing:individually in suspended metal cages
- Diet (e.g. ad libitum): conventional, ad libitum
- Water (e.g. ad libitum): mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20 December 2001 To: 27 December 2001

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 (about 55 mg)

Duration of treatment / exposure:
the test substance was not washed out of the eye during the 72-h observation period
Observation period (in vivo):
1, 24, 48 and 72 h
Number of animals or in vitro replicates:
Initially 1, then 2 more tested
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: using the Draize scale (Draize, 1977):
Score for conjunctiva = (redness + chemosis + discharge) X 2
Score for iris = degree of effects X 5
Score for cornea = (degree of opacity X area involved) X 5

Ocular irritancy potential was classified according to a modified version of the method of Kay and Calandra (1962). The scores for cornea, iris and conjunctiva for each time point were added together for each rabbit and the group mean calculated. The highest of these group means, together with the persistence of the reactions was used to classify the irritancy potential.

TOOL USED TO ASSESS SCORE: ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 h
Score:
ca. 4.2
Max. score:
110
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 h
Score:
0
Max. score:
80
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 h
Score:
0
Max. score:
10
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 h
Score:
ca. 4.2
Max. score:
20
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
No effects were seen on the cornea or iris in any of the three rabbits. Moderate conjunctival irritation was noted in all of the rabbits after 1 h, which was minimal at 24 h and had fully reversed by 48 h.
Other effects:
There was an initial pain reaction of 2 (slight pain; rabbit blinks and tries to open eye, but reflex closes it)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a GLP study conducted according to OECD Guideline 405, EDDS acid (when applied to the right eye of three rabbits) produced moderate irritation of the conjunctivae after 1 h, which had completely reversed by 48 h. No effects on the cornea or iris were evident.
Executive summary:

In a GLP study conducted according to OECD Guideline 405, EDDS acid was tested for its ability to cause eye irritation in rabbits. The test substance (0.1 mL) was placed in the conjunctival sac of the right eye of three New Zealand White rabbits and the eyelids held together for about one second (no washing). The left eye was left untreated and acted as the control. Assessment of ocular irritation was made at 1, 24, 48 and 72 h using the scoring method of Kay and Calandra (1962) and an ophthalmoscope.

No effects on the cornea or iris were evident. Moderate irritation of the conjunctivae was seen with scores of 2 each for redness, chemosis and discharge at 1 h, which had receded to a score of 1 (at the most) for each parameter by 24 h. The eyes of all three rabbits appeared normal at 48 and 72 h. In conclusion, under the conditions of this test, EDDS was considered to be non-irritating when applied to the rabbit eye (mean scores at 24, 48 and 72 h) according to the EU CLP and DSD regulations.