Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The testing was conducted between 29 June 2009 to 28 July 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Fully GLP and test guideline 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:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

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

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Bicester, Oxon, UK
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: 15 to 23 g
- Housing: Individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes.
- Diet (e.g. ad libitum): Free access to 2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK
- Water (e.g. ad libitum): Free access to mains tap water.
- Acclimation period: At least 5 days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 oC
- Humidity (%): 30 to 70%
- Air changes (per hr): approx. 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours continuous light (06.00 to 18.00) and 12 hours darkness.


IN-LIFE DATES: From: 29.06.2009 To: 28.07.2009

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
25%, 10% and 5% in dimethyl formamide.
No. of animals per dose:
Four animals per dose.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
27.44
Test group / Remarks:
4
Remarks on result:
other: see Remark
Remarks:
Concentration (% v/v) in dimethyl formamide: 5 Result: Positive
Parameter:
SI
Value:
41.49
Test group / Remarks:
4
Remarks on result:
other:
Remarks:
Concentration (% v/v) in dimethyl formamide: 10 Result: Positive
Parameter:
SI
Value:
71.34
Test group / Remarks:
4
Remarks on result:
other:
Remarks:
Concentration (% v/v) in dimethyl formamide: 25 Result: Positive

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Remarks:
Migrated information
Conclusions:
The test material was considered to be a sensitiser under the conditions of the test.
Executive summary:

The test material was considered to be a sensitiser under the conditions of the test.