Registration Dossier
Registration Dossier
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EC number: 237-655-9 | CAS number: 13887-98-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-11-27 to 1990-11-30
- 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 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2'-[oxybis(2,1-ethanediyloxy)]bisacetic acid
- EC Number:
- 237-655-9
- EC Name:
- 2,2'-[oxybis(2,1-ethanediyloxy)]bisacetic acid
- Cas Number:
- 13887-98-4
- Molecular formula:
- C8H14O7
- IUPAC Name:
- 2-{2-[2-(carboxymethoxy)ethoxy]ethoxy}acetic acid
- Test material form:
- other: liquid: clear colourless
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Age at study initiation: 3-5 months
- Weight at study initiation: 2,3 - 3,8 kg
- Housing: single
- Diet: ad libitum, Altromin 2123
- Water: ad libitum, deionized water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- readings were conducted 30-60 min, 24, 48 and 72 h after removal of the test substance
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal, appr. 25 cm^2
- Type of wrap if used: cellulose patch covered by a semiocclusive patch
REMOVAL OF TEST SUBSTANCE
- Washing: rinsing with lukewarm water
- Time after start of exposure: directly after removal of the patch ( 4h)
OBSERVATION TIME POINTS
30-60 min, 24, 48 and 72 h
SCORING SYSTEM:
5 graded scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation were detected.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was not irritating to skin in this in vivo study.
- Executive summary:
0.5 mL of the undiluted test material was applied to the clipped skin of three New Zealand White rabbits for 4 hours under semiocclusive dressing. After removal of the patches the test sites were washed with lukewarm water. Skin findings were scored 30-60 min, 24 h, 48 h and 72 h after removal of the test substance. As a result, no signs of irritation (edema oder erythema) were found on the tested skin sites. Therefore it was concluded that the tested substance is not irritating to skin.
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