Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 700-129-9 | CAS number: 2004-62-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- other: Episkin Reconstituted Human Epidermis Model
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Testing was conducted between 04 June 2009 and 10 June 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully GLP compliant study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Episkin Reconstituted Human Epidermis Model
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,3'-(hexane-1,6-diyldiimino)dipropanenitrile
- EC Number:
- 700-129-9
- Cas Number:
- 2004-62-8
- Molecular formula:
- C12H22N4
- IUPAC Name:
- 3,3'-(hexane-1,6-diyldiimino)dipropanenitrile
Constituent 1
Test animals
- Species:
- other: Reconstituted Human Epidermis Model
- Strain:
- other: Reconstituted Human Epidermis Model
- Details on test animals or test system and environmental conditions:
- The EPISKIN(TM) model is a three-dimensional reconstituted human epidermis model consistting of adult human-derived epidermal keratinocytes seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. A highly differentiated and statified epidermis model is obtained after a 13 day culture period comprising the main basel, supra basel, spinous and granular layers and a functional corneum.
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: Reconstituted human epidermis model
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Negative and positive control tissues were used.
- Amount / concentration applied:
- Amount applied: 10 micro litres.
- Duration of treatment / exposure:
- 15 minutes.
- Observation period:
- 42 hours.
- Number of animals:
- Not applicable. Triplicate tissues were treated with the test material.
- Details on study design:
- .
Results and discussion
In vivo
Results
- Irritation parameter:
- other: relative mean tissue viability
- Basis:
- other: absorbance/optical density measurements
- Time point:
- other: 15 minutes
- Score:
- 102.4
- Reversibility:
- no data
- Irritant / corrosive response data:
- The relative mean viability of the test material treated tissues was 102.4% after a 15-minute exposure. Data are presented in the form of percentage viability (MTT reduction in the test material treated tissues relative to negative control tissues).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
The test material was considered to be Non-Irritant.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
