Tetramethylenediamine

Skin sensitisation

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

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

Test material information

Constituent 1

Reference substance name:

Tetramethylenediamine

EC Number:

203-782-3

EC Name:

Tetramethylenediamine

Cas Number:

110-60-1

Molecular formula:

C4H12N2

IUPAC Name:

butane-1,4-diamine

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)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

water

Induction 2

Concentration / amount:

Induction: intradermally injection with a 0.1% concentration and epidermally exposed to 10% concentration
Challenge: 2% concentration with bandage

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

water

Challenge 2

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)

Results

Results 1

Reading:

other:

Hours after challenge:

48

Group:

test chemical

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.

Results 2

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)
	A	B	C	Erythema	Oedema
Control
51	E2	NA	E1	0	0
52	E1	NA	E1	0	0
53	E2	NA	E1	0	0
Experimental
54	E2	N3	E2	0	0
55	E2	N3	E2	2	0
56	E2	N2	E1	0	0
57	E2	N3	E2	2	0
58	E3	N2	E3	0	0
59	N2	N3	E2	1	0
60	E2	N2	E2	0	0

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	0	0	0	0
52	0	0	0	0
53	0	0	0	0
Experimental
54	0	0	0	0	not sensitised
55	0	0	0	0	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.