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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Historical study
Species:
guinea pig
Strain:
Himalayan
Sex:
female
Details on test animals and environmental conditions:
Body weight 347 - 446 grams,
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Intradermal

A) The test substance dissolved to 1% (wlw) with physiological saline,
B) Freunds' Complete Adjuvant (FCA, Difco, Detroit, U.S.A.), 50:50 with distilled water for injection (pyrogen free, Ferensius AG, Bad Homburg,
Germany).
C) The test substance, at twice the concentration used in (A), emulsified in a 50:50 mixture of Freunds' Complete Adjuvant.

Epidermal applications:
Test substance (25 % (wlw) in distilled water).
Route:
epicutaneous, semiocclusive
Vehicle:
physiological saline
Concentration / amount:
Intradermal

A) The t e s t substance dissolved to 1% ( w l w ) with physiological saline,
B) Freunds' Complete Adjuvant (FCA, Difco, Detroit, U.S.A.), 50:50 with d i s t i l l e d water f o r i n j e c t i o n (pyrogen free, Ferensius AG, Bad Homburg,
Germany).
C) The t e s t substance, a t twice the concentration used i n (A), emulsified i n a 50:50 mixture of Freunds' Complete Adjuvant.

Epidermal applications:
Test substance (25 % ( w l w ) i n d i s t i l l e d water).
No. of animals per dose:
Preliminary study : 5 females, Experimental group: 20 females, Control group : 10 females
Details on study design:
The vehicle control group was composed of 10 female Himalayan albino  
guinea pigs.  The triethylenediamine treated group was composed of 20 
females.  1.0 % triethylenediamine in physiological saline was the 
concentration selected for the intradermal induction dose. 25%  
triethylenediamine in distilled water was the concentration selected for 
the epidermal induction dose.  10% triethylenediamine in distilled water 
was the concentration selected for the first challenge dose. 
5%  triethylenediamine in distilled water was the concentration selected for 
the second challenge dose.
Challenge controls:
The test and control guinea pigs were challenged two weeks after the epidermal induction application. Hair was clipped and shaved from a 5 x 5 cm area on the left flank of each guinea pig. A volume of 0.05 m l of each of the following three test substance concentrations and the vehicle were applied using square chambers attached to Micropore tape:
a = 10 % (w/w) in distilled water.
b = 5 % (w/w) in distilled water.
c = 2 % (w/w) in distilled water.
d = distilled water.
Positive control substance(s):
yes
Remarks:
Formaldehyde
Positive control results:
Clearly positive results were observed i n the experimental animals after the challenge with 0.25% (wlw) FORMALDEHYDE in distilled water.
Reading:
1st reading
Group:
test chemical
Dose level:
0 %, 2 %, 5 %, 10 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
results were considered inconclusive
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
negative control
Dose level:
0 %, 2 %, 5 %, 10 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Group:
test chemical
Dose level:
0 %, 2 %, 5 %, 10 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
not sensitised
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Group:
negative control
Dose level:
0 %, 2 %, 5 %, 10 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
positive control
Dose level:
0,25 % formaldehyde
No. with + reactions:
12
Total no. in group:
20
Clinical observations:
Clearly positive results were observed in the experimental animals after the challenge with 0.25% ( w l w ) FORMALDEHYDE in distilled water.
Remarks on result:
positive indication of skin sensitisation

In the vehicle control group, no positive reactions were evident after  the first

 and second challenge application.  
In the positive control group (0.25% formaldehyde in distilled water),  positive 

reactions were evident after the challenge application.  

A 60%  sensitization rate was observed in the positive control group.
The epidermal exposure of DABCO Triethylenediamine in the induction phase 

resulted in severe skin irritation. 

The epidermal exposure of DABCO Triethylenediamine in the second challenge  

phase resulted in no positive sensitization reactions in response to the  

test article concentrations.
No symptoms of systemic toxicity were observed in the animals during the study. No mortality occurred during the study.
The average body weight gain of experimental and control animals was unaffected by treatment.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions used in this study, DABCO Triethylenediamine induced no sensitization.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

1,4-Diazabicyclo[2.2.2]octane is not sensitizing to the skin of guinea pigs.


Migrated from Short description of key information:
1,4-Diazabicyclo[2.2.2]octane was tested for skin sensitization in guinea pigs using the method of Magnusson and Kligman in two separate studies and was reported to be negative in both studies. The positive controls for these studies (DNCB and formaldehyde) showed expected sensitization rates. In one study the vehicle control group was composed of 5 male and 5 female Dunkin-Hartley albino guinea pigs and the test material-treated group was composed of 10 males and 10 females. 0.1% 1,4-Diazabicyclo[2.2.2]octane in physiological saline was the concentration selected for the intradermal induction dose. 25% 1,4-Diazabicyclo[2.2.2]octane in physiological saline was the concentration selected for the epidermal induction dose. 10% 1,4-Diazabicyclo[2.2.2]octane in physiological saline was the concentration selected for the first and second challenge dose. In the other study, the vehicle control group was composed of 10 female Himalayan albino guinea pigs and the test material-treated group was composed of 20 females. 1.0% 1,4-Diazabicyclo[2.2.2]octane in physiological saline was the concentration selected for the intradermal induction dose. 25% 1,4-Diazabicyclo[2.2.2]octane in distilled water was the concentration selected for the epidermal induction dose. 10% 1,4-Diazabicyclo[2.2.2]octane in distilled water was the concentration selected for the first challenge dose. 5% 1,4-Diazabicyclo[2.2.2]octane in distilled water was the concentration selected for the second challenge dose. Taking both studies into consideration, none of the forty 1,4-Diazabicyclo[2.2.2]octane-induced animals showed signs of sensitization when challenged with up to 10% 1,4-Diazabicyclo[2.2.2]octane.

Justification for selection of skin sensitisation endpoint:
Most recent and reliable study.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Justification for selection of respiratory sensitisation endpoint:
1,4-Diazabicyclo[2.2.2]octane is not respirable in its neat form.

Justification for classification or non-classification

Data is sufficient and no classification is required