3-dimethylaminopropan-1-ol

Endpoint summary

Description of key information

Dimethylaminopropanol was found to be corrosive to the rabbit skin under occlusive conditions. Dermal application for 15 min caused necrosis, while a 20-hour exposure induced necrosis and severe erythema and edema after 24 hours. After 8 days, strong/movable necrosis was observed.
A single application of undiluted dimethylaminopropanol to the rabbit eye caused corrosion with severe corneal opacity. Further observations after 24 h: nictitating membrane grey; mucous membrane partly grey, ciliary injection; smeary stratification; mucosa partly corroded, partly blood; iritis; staphyloma and incorporated vessels.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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 study report which meets basic scientific principles.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Method: BASF-Test: Animals were treated for 1, 5, 15 min and 20 hours using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application time (1, 5 and 15 min) the skin was washed with Lutrol (50%). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 24 hours and at the end of the observation period (8 days). For a final evaluation, the findings after 48 h and 72 h from the raw data were taken into account.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Type of coverage:

occlusive

Preparation of test site:

other: intact skin

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): about 1 ml

Duration of treatment / exposure:

1, 5 , 15 min and 20 h

Observation period:

8 d

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm (patch test)

Irritation parameter:

erythema score

Remarks:

1 min exposure

Basis:

mean

Time point:

other: 24 h - 8 d

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Remarks:

5 min exposure

Basis:

mean

Time point:

other: 24 h - 8 d

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Remarks:

15 min exposure

Basis:

mean

Time point:

other: 24 h - 8 d

Score:

1 - 2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: necrosis, staining, scaling

Irritation parameter:

erythema score

Remarks:

20 h exposure

Basis:

mean

Time point:

other: 24 h - 8 d

Score:

2 - 3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: necrosis, anaemia, leatherlike skin

Irritation parameter:

edema score

Remarks:

1 min exposure

Basis:

mean

Time point:

other: 24 h - 8 d

Score:

0

Max. score:

4

Irritation parameter:

edema score

Remarks:

5 min exposure

Basis:

mean

Time point:

other: 24 h - 8 d

Score:

0

Max. score:

4

Irritation parameter:

edema score

Remarks:

15 min exposure

Basis:

mean

Time point:

other: 24 h - 8 d

Score:

1 - 2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: necrosis, staining, scaling

Irritation parameter:

edema score

Remarks:

20 h exposure

Basis:

mean

Time point:

other: 24 h - 8 d

Score:

2 - 3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: necrosis, anaemia, leatherlike skin

Irritant / corrosive response data:

After 8 days, strong/movable necrosis was observed (both animals).

Interpretation of results:

corrosive

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye 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 study report which meets basic scientific principles

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Method: BASF-Test: 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report describes findings after 1 and 24 hours and at the end of the observation period. For final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml

Duration of treatment / exposure:

24 h

Observation period (in vivo):

8 d

Number of animals or in vitro replicates:

2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 8 d

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 8 days

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1 h - 24 h - 8 d

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 8 d

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 h

Score:

0

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 8 d

Score:

1

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Irritant / corrosive response data:

Further observations: nictitating membrane grey; mucous membrane partly grey, ciliary injection; smeary stratification; bloody secretion

Interpretation of results:

corrosive

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin irritation

In a skin irritation test comparable to OECD guideline 404, dimethylaminopropanol was applied to the skin of Vienna White rabbits for 1, 5, 15 min or 20 hours (using 2 animals at all exposure durations) under occlusive conditions and observed for 8 days (BASF AG, 1969; 1975). Application did not cause any or only slight effects after 1 and 5 min of exposure. Dermal application for 15 min caused necrosis, while a 20-hour exposure induced necrosis and severe erythema and edema after 24 hours. After 8 days, strong/movable necrosis was observed. Dimethylaminopropanol was judged corrosive to the skin.

Eye irritation

In an eye irritation test comparable to OECD guideline 405, dimethylaminopropanol was applied to conjunctival sac of the eyes of 2 Vienna White rabbits (BASF AG, 1969; 1975). Animals were observed after 1 and 24 hours and up to 8 days after the treatment. The application caused corrosion (irreversible), predominantly expressed by severe corneal opacity. Dimethylaminopropanol was judged corrosive to the eyes.

Justification for classification or non-classification

Based on the available data, dimethylaminopropanol needs to be classified as corrosive to the skin and eyes according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 (Category 1B, H314, causes severe skin burns and eye damage).