Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Episkin Reconstituted Human Epidermis Model
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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

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.