Registration Dossier
Registration Dossier
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EC number: 906-936-4 | CAS number: -
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Remarks:
- Cumulative Irritation Patch Test
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Sufficient human data is available for interpretation of results.
- Justification for type of information:
- Read across is based on the category approach. Please refer to attached category document.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
- Type of study / information:
- Cumulative irritation patch test study with human volunteers
- Endpoint addressed:
- skin irritation / corrosion
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3,6,9-trioxaundecane-1,11-diol
- EC Number:
- 203-989-9
- EC Name:
- 3,6,9-trioxaundecane-1,11-diol
- Cas Number:
- 112-60-7
- Molecular formula:
- C8H18O5
- IUPAC Name:
- 2,2'-[oxybis(ethane-2,1-diyloxy)]diethanol
Constituent 1
Method
- Ethical approval:
- confirmed and informed consent free of coercion received
- Details on study design:
- Occlusive patches applied to the infrascapular area of the back, either to the right or left of the midline. On day 1, the material was applied to the designated path sites. 0.2 ml of each test substance were applied. Twenty-four hours later, the patches were removed, the sites evaluated and identical patches reapplied to the same sites. This was repeated daily for a period of twenty-one days. The patches applied on Friday were not removed until Monday. Occlusive patches were non-porous, plastic film adhesive bandages with 2 cm x 2 cm Webril.
- Exposure assessment:
- not specified
Results and discussion
- Results:
- The mean primary dermal irritation index (PDII) for TTEG for days 1-21 was 12.6. No significant irritation was observed after repeated exposure to TTEG.
Applicant's summary and conclusion
- Conclusions:
- No significant irritation was observed after repeated exposure to tetraethylene glycol in a human cumulative irritation patch test.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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