Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 days
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study procedures were based on the test method described by Magnusson and Kligman, "Allergic Contact Dermatitis in the Guinea Pig, Identification of Contact Allergens" (OECD 406 Skin Sensitisation). Specific data on animal strain, sex and environmental conditions is not reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
The Guinea Pig Maximisation Test (GPMT) of Magnusson and Kligman.
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Clear colourless liquid, stability in water: at least 96 hours

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Albino guinea pig
Sex:
not specified
Details on test animals and environmental conditions:
no data reported

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Induction: intradermally injection with a 0.1% concentration and epidermally exposed to 10% concentration
Challenge: 2% concentration with bandage
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction: intradermally injection with a 0.1% concentration and epidermally exposed to 10% concentration
Challenge: 2% concentration with bandage
No. of animals per dose:
Control group: 3 animals (induction only with vehicle - distilled water), challenge 2% epidermal
Induction group: 7 animals (0.1% intradermally, 10% epidermally), challenge 2% epidermal
Details on study design:
Two weeks after induction phase (control and exposed animals), all animals were challenged with a 2% test substance concentration and the vehilcle. The challenge reactions were assessed 24 and 48 hours after bandage removal.
Challenge controls:
all animals were challenged with a 2% test substance concentration and the vehilcle. The challenge reactions were assessed 24 and 48 hours after bandage removal
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other:
Hours after challenge:
48
Group:
test group
Dose level:
2% concentration
No. with + reactions:
0
Total no. in group:
7
Clinical observations:
no sensitisation
Remarks on result:
other: Reading: other:. . Hours after challenge: 48.0. Group: test group. Dose level: 2% concentration. No with. + reactions: 0.0. Total no. in groups: 7.0. Clinical observations: no sensitisation.
Reading:
other:
Hours after challenge:
48
Group:
negative control
Dose level:
2% concentration (without induction by test substance)
No. with + reactions:
0
Total no. in group:
3
Clinical observations:
no sensitisation
Remarks on result:
other: Reading: other:. . Hours after challenge: 48.0. Group: negative control. Dose level: 2% concentration (without induction by test substance). No with. + reactions: 0.0. Total no. in groups: 3.0. Clinical observations: no sensitisation.

Any other information on results incl. tables

Induction readings

 Animal number Intradermal  injection  (day 3)  Epidermal Exposure (10% DAB) 
  Erythema  Oedema 
Control           
51  E2  NA  E1 
52  E1  NA  E1 
53  E2  NA  E1  0
Experimental           
54  E2  N3  E2 
55  E2  N3  E2 
56  E2  N2  E1 
57  E2  N3  E2 
58  E3  N2  E3 
59  N2  N3  E2 
60  E2  N2  E2 
         

A: 1:1 mixture of FCA and water for injection

B: A 0.1% test substance concentration (experimental); vehicle (control)

C: 1:1 mixture of FCA and a 0.2% concentration (experimental) or vehicle (control)

Skin effects intradermal injections:

NA: no abnormalities

E: Erythema graded according to Draize

N: Signs of necrosis (mm in diameter)

Challenge readings

Animal no.  day 24  day 24  day 25  day 25  comments 
  2%  vehicle  2%  vehicle   
Control           
51   
52   
53   
Experimental           
54  not sensitised 
55  not sensitised 
56  0 0 0 0 not sensitised
57 0 0 0 0 not sensitised
58 0 0 0 0 not sensitised
59 0 0 0 0 not sensitised
60 0 0 0 0 not sensitised

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
No evidence was obtained that DAB (1,4 diaminobutane) caused skin hypersensitivity in the guinea pig. This result lead to a sensitization rate of 0%. indicating that DAB (1,4 diaminobutane) need not to be regarded as a potential skin sensitiser.
Executive summary:

7 Experimental animals were intradermally injected with a 0.1% concentration and epidermally exposed to a 10% concentration, while 3 control animals were similarly treated, but with the vehicle only.

2 Weeks after the epidermal application all animals were challenged with a 2% test substance concentration and the vehicle. The challence reactions were assessed 24 and 48 hours after bandage removal.

No evidence was obtained that DAB (1,4 Diaminobutane) caused skin hypersensitivity in the guinea pig. This result leads to a sensitisation rate of 0%, indicating that DAB (1,4 Diaminobutane) need not to be regarded as a potential skin sensitiser.