Propylenediamine

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:

other: Acceptable, well documented report which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1966

Report date:

1966

Materials and methods

Principles of method if other than guideline:

BASF test: Two animals were treated for 1, 5 or 15 min using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. The animals were observed for 8 days and skin changes were recorded daily. For a final evaluation, the findings from 24 and 48 hours from the raw data were taken into account.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propylenediamine

EC Number:

201-155-9

EC Name:

Propylenediamine

Cas Number:

78-90-0

Molecular formula:

C3H10N2

IUPAC Name:

propane-1,2-diamine

Details on test material:

- Name of test material (as cited in study report): 1,2-Propylendiamin
- Analytical purity: 99 %

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.0 and 3.1 kg

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal served as control

Amount / concentration applied:

pure

Duration of treatment / exposure:

1, 5 and 15 min

Observation period:

8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2.5x2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): conc. Lutrol and 50 % Lutrol solution
- Time after start of exposure: 1, 5 or 15 min post exposure

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Necrosis-score

Basis:

mean

Remarks:

1, 5 and 15 min exposure

Time point:

24 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Results 2

Irritation parameter:

other: Necrosis-score

Basis:

mean

Remarks:

1, 5 and 15 min exposure

Time point:

other: 8 d

Score:

3

Max. score:

3

Reversibility:

not reversible

Irritant / corrosive response data:

Slight erythema (grade 2), slight edema (grade 1), partly extended beyond the area of exposure were observed in all animals on the day of application. After a 1 min exposure necrosis (grade 3) was observed. A 5 min or 15 min exposure led to leathery-like full thickness necrosis (grade 3).

Applicant's summary and conclusion

Interpretation of results:

Category 1A (corrosive) based on GHS criteria

Conclusions:

The test substance caused severe necrosis after an 1-min exposure. The first scoring was made 24 h after the application of the test substance. As it cannot be excluded that the corrosive effects already occurred during an observation period ≤ 1 h, the test substance is assigned to category 1A .

Executive summary:

In a primary skin irritation study (BASF test), the undiluted test substance was applied to the back of two Vienna White rabbits for 1, 5 or 15 min using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the liquid test substance. The animals were observed for 8 days and skin changes were recorded daily.

After a 1-min exposure necrosis (grade 3) was observed. A 5-min or 15-min exposure led to leathery-like full thickness necrosis (grade 3). Additionally, slight erythema (grade 2) and slight edema (grade 1), partly extending beyond the area of exposure were observed in all animals on the day of application.