Registration Dossier
Registration Dossier
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EC number: 608-035-9 | CAS number: 27014-42-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study under GLP without deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Poly(oxy-1,2-ethanediyl), a,a',a'',a'''-[1,2-ethanediylbis(nitrilodi-2,1-ethanediyl)]tetrakis[w-hydroxy-
- EC Number:
- 608-035-9
- Cas Number:
- 27014-42-2
- IUPAC Name:
- Poly(oxy-1,2-ethanediyl), a,a',a'',a'''-[1,2-ethanediylbis(nitrilodi-2,1-ethanediyl)]tetrakis[w-hydroxy-
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand albino rabbit
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- The exposure period was 4 hours. After the exposure period aU remnants of the test substance were carefully removed from the skin with warm tap water.
- Observation period:
- Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches.
- Number of animals:
- 3
- Details on study design:
- About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm2 . Only animals with intact skin were used.
Each animal was treated with 0.5 ml of the substance. The substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical
plaster (specially produced by Beiersdorf AktiengeseHschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.
Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches.
Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE. All other changes of the skin were recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 1d
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not skin irritating.
- Executive summary:
The substance is not skin irritating.
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