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Registration Dossier
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EC number: 205-999-9 | CAS number: 280-57-9
Skin sensitisation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- 1,4-diazabicyclooctane
- EC Number:
- 205-999-9
- EC Name:
- 1,4-diazabicyclooctane
- Cas Number:
- 280-57-9
- Molecular formula:
- C6H12N2
- IUPAC Name:
- 1,4-diazabicyclooctane
- Test material form:
- solid: crystalline
- Details on test material:
- Dabco triethylenediamine (lot # 84008302) 99.9% purity
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- Body weight 347 - 446 grams,
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- 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).
Challengeopen allclose all
- 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
Results and discussion
- Positive control results:
- Clearly positive results were observed i n the experimental animals after the challenge with 0.25% (wlw) FORMALDEHYDE in distilled water.
In vivo (non-LLNA)
Resultsopen allclose all
- 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
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- 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.
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