Tetramethylenediamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

48 hours

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: rangefinding study on behalf of the sensitization study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Priliminary irritation study (executed for rangefinding in the sensitisation study)
Guinea pigs were exposed interdermally by injection to a concentration of 50%, 20%, 10%, 5%, 2%, 1%, 0.5%, 0.1% DAB
After 24 and 48 hours the Erythema grade and Necrosis area were scored.

GLP compliance:

not specified

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:

Test substances: clear colourless liquid; vehicle : distilled water
Stability in vehicle: at least 96 hours.

Test animals

Species:

guinea pig

Strain:

other: Albino Guinea Pig

Details on test animals or test system and environmental conditions:

No data

Test system

Type of coverage:

other:

Preparation of test site:

other: intradermal injection & epidermal exposure

Vehicle:

water

Controls:

no

Amount / concentration applied:

50%, 20%, 10%, 5%, 2%, 1%, 0.5%, 0.1% DAB

Duration of treatment / exposure:

48 hours

Observation period:

48 hours

Number of animals:

7 animals

Details on study design:

Guinea pigs were exposed interdermally by injection to a concentration of 50%, 20%, 10%, 5%, 2%, 1%, 0.5%, 0.1% DAB
After 24 and 48 hours the Erythema grade and Necrosis area were scored.

Results and discussion

In vivo

Results

Irritation parameter:

erythema score

Basis:

animal: 42

Time point:

other: 24 hours

Score:

2

Reversibility:

other: 10%: no improvement at 48 hours; 5% score improved to 1 afther 48 hours

Irritant / corrosive response data:

The Guinea pigs exposed intradermally to a concentration to 50% & 20% and 10% & 5%, were sacirficed for ethical reasons, since they showed large areas of necrosis at the sites of injection shortly after treatment.
The Guinea pig exposed epidermally to a concentration of 20% and 50% was sacrificed after 24 hours for ethical reasons; the treated skin area showed eschar formation. Oedema could not be scored in this animal.

Other effects:

Intradermal exposure: necrosis at all injection sites; diameter dependend on dose.
Epidermal exposure: 10% and 5%: erythema and oedema; <2% no effects scored.

Any other information on results incl. tables

Preliminary irritation study; skin reactions after intradermal injection

Animal number	Conc. %	Time after injection
		24 hours			48 hours
		Erythema (grade)		Necrosis (mm)	Erythema (grade)	Necrosis (mm)
40	50	*
40	20
41	10	*
41	5
42	2			10		10
42	1			10		10
1	0.5			7		7
1	0.1			3		3

* the animal was sacrifieced for ethical reasons, since it showed large areas of necrosis at the sites of injetion shortly after treatment.

Priliminary study: Skin reactions after epidermal exposure

Animal number	Conc. %	Time after injection
		24 hours			48 hours
		Erythema (grade)		Oedema	Erythema (grade)	Oedema
39	50	4 *		-
39	20	4 *		-
42	10	2		1	2	1
42	5	2		1	1	0
2	2	0		0	0	0
2	1	0		0	0	0
2	0.5	0		0	0	0
2	0.1	0		0	0	0

* the treated skin area showed eschar formation. Oedema could not be scored. The animal was sacrificed for ethical reasons immediately after the 24 hour obeservation.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Causes burns Criteria used for interpretation of results: EU

Conclusions:

Corrosive, R34 Causes burns

Executive summary:

Intradermal and epidermal exposure to DAB concentrations (preliminary study for rangefinding for the sensitization study) induced necrosis, erythema and oedema. Some animals had to be sacrificed for ethical reasons shortly after exposure.

NOAEL: 2% (no erythema, oedema, nor sensitization)

DSD: Corrosive, R34 Causes burns

CLP: Danger, H314 Causes serious burns