Registration Dossier
Registration Dossier
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EC number: 245-516-9 | CAS number: 23243-68-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-10-23 to 1990-10-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2'-[ethylenebis(oxy)]bisacetic acid
- EC Number:
- 245-516-9
- EC Name:
- 2,2'-[ethylenebis(oxy)]bisacetic acid
- Cas Number:
- 23243-68-7
- Molecular formula:
- C6H10O6
- IUPAC Name:
- 2-[2-(carboxymethoxy)ethoxy]acetic acid
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: D271
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 3.8 kg
- Housing: individually
- Diet: ad libitum (Altromin 2123), hay
- Water: ad libitum (deionised, chlorated water)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100 mg
- Duration of treatment / exposure:
- single treatment, the eye was washed out after 24 hours with physiological saline
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after application
- Number of animals or in vitro replicates:
- 1 animal
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Yes (physiological saline solution)
- Time after start of exposure: 24 hours
SCORING SYSTEM: according to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritant / corrosive response data:
- 24 h up to 7 days p.a. the animal exhibited a swollen and reddened conjunctiva and a reddened iris. Eyelids were more than halfly closed. Clear-clourless to whitish discharge was observed. On day 7, the cornea surface appeared uneven and the conjunctiva was partly detaching.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test item is considered to cause serious eye damage in the rabbits' eye.
- Executive summary:
The acute eye irritation study of the test item was performed in one New Zealand White rabbit according to OECD 405. The irritation effect of the test item was evaluated according to the Draize method. A single dose of 100 mg of the test item was placed into the conjunctival sac of the left eye. The untreated right eye served as control. The treated eye of the test animal was washed out 24 hours after application. The eye was examined at 1, 24, 48, and 72 hours after the application. From 24 h up to 7 days after treatment the animal exhibited a swollen and reddened conjunctiva and a reddened iris. Eyelids were more than halfly closed. Clear-clourless to whitish discharge was observed. On day 7, the cornea surface appeared uneven and the conjunctiva was partly detaching. The animal was sacrificed on day 7. Based on these findings the test item was considered to cause serious eye damage.
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