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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data from secondary source

Data source

Reference
Reference Type:
secondary source
Title:
Skin sensitization study of 1,4-Diazabicyclooctane was performed in guinea pig
Author:
OECD HPV SIDS
Year:
2005
Bibliographic source:
OECD HPV Chemical Programme, SIDS Dossier approved at SIAM 21,2005

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Skin sensitization study of 1,4-Diazabicyclooctane was performed in guinea pig by using Guinea pig maximisation test
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triethylenediamine
- Molecular formula : C6H12N2
- Molecular weight :112.174g/mole
- Substance type: organic
- Physical state: solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Triethylenediamine
- Molecular formula : C6H12N2
- Molecular weight :112.174g/mole
- Substance type: organic
- Physical state: solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Dunkin-Hartley albino
Sex:
male/female
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1%
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
25%
Challengeopen allclose all
No.:
#1
Route:
other: No data available
Vehicle:
physiological saline
Concentration / amount:
10%
No.:
#2
Route:
other: No data available
Vehicle:
physiological saline
Concentration / amount:
10%
No. of animals per dose:
Total :30
Treated group:20
Male:10 and female:10
Control group:10
Male :5 and female: 5
Details on study design:
Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:2
- Exposure period: No data available
- Test groups:20
- Control group:10
- Site: No data available

- Frequency of applications:
- Duration: No data available

- Concentrations: 1)0.1%
2) 25%

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: No data available

- Exposure period: No data available

- Test groups:20
- Control group:10
- Site: No data available

- Concentrations:1 %
- Evaluation (hr after challenge): No data available
Challenge controls:
No data available
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
No data available

Results and discussion

Positive control results:
No data available

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No indication of skin sensitization after the challenge application
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Group:
positive control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No indication of skin sensitization after the challenge application
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Not Sensitizing
Conclusions:
The skin sensitization study of Triethylenediamine (280-57-9) was performed by Guinea pig maximisation test was considered to be not skin sensitizing in guinea pig .
Executive summary:

The skin sensitization study of Triethylenediamine(280-57-9)was performed by Guinea pig maximisation testin 20 Male and female Dunkin-Hartley albino guinea pigs. An additional 10 animals served as the vehicle control group; a positive control group was not included in the study.

 In induction phase,1st induction given using 0.1concentration inphysiological saline by intradermal route while in 2ndinduction done by using 25% concentration by epidermal application.In challenge phase, test substance 10 % concentration in same vehicle used for first and second challenge dose. No skin sensitizing reaction observed after challenge application. 2 Female showed emaciation at day 36 and37. One Female showed emaciation from day 36 to 39 of test. While 2 female showed diarrhea at day 37.The body weight gain of the animals was not affected during the test with the exception of 3 animal,2 female died spontaneously at day 37 of the test study. No macroscopic findings were observed at necropsy for these animals had reddened abdominal wall, reddened diaphragm, and fluid in the myocardium were observed. Hence it is considered that Triethylenediamine(280-57-9)was not skin sensitizing in guinea pig by Guinea pig maximisation test.