2,2-dimethylpropane-1,3-diamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Principles of method if other than guideline:

according to BASF-internal standard

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dimethylpropane-1,3-diamine

EC Number:

230-819-0

EC Name:

2,2-dimethylpropane-1,3-diamine

Cas Number:

7328-91-8

Molecular formula:

C5H14N2

IUPAC Name:

2,2-dimethylpropane-1,3-diamine

Details on test material:

Name of the test substance used in the study report: Neopentandiamin (= 1,3-Diamino-2,2-dimethylpropan)

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

Mean body weight: 3 kg
The animals were offered a standardized animal laboratory diet.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

ca. 1 ml

Duration of treatment / exposure:

3 min

Observation period:

8 d

Number of animals:

2

Details on study design:

Application area: 2.5 x 2.5
Application site: back of the rabbits
The test substance was washed off with Lutrol.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 3 min

Score:

3

Max. score:

3

Reversibility:

other: severe, not relocatable necrosis after days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 3 min

Score:

3

Max. score:

3

Reversibility:

other: leather-like necrosis after 8 days

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 3 min

Score:

2

Max. score:

2

Reversibility:

not reversible

Irritant / corrosive response data:

The skin findings were macroscopically confirmed by the pathologist.

Any other information on results incl. tables

Animal No.	3 min		1 day		2 days		8 days
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
1	3 e	2	4 Np	3	4 Np	2	4 Nh	2
2	3 e	2	4 Np	2	4 Np	2	4 Nl	2

 

e: extending beyond the area of exposure

N: necrosis (p: parchment-like; h: hard/displacable; l: leathery)

Applicant's summary and conclusion

Interpretation of results:

Category 1A (corrosive) based on GHS criteria

Conclusions:

The test substance is corrosive to skin.