N,N-dimethylbutylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Method: other: 40 CFR, Parts 160 and 792

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dimethylbutylamine

EC Number:

213-156-1

EC Name:

N,N-dimethylbutylamine

Cas Number:

927-62-8

Molecular formula:

C6H15N

IUPAC Name:

N,N-dimethylbutylamine

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): C1331 N,N-dimethylbutylamine
-Sprinborn ID: S88.021.3206
- Physical state: clear liquid
- Analytical purity:
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mohican Valley Rabbitry, Loudonville, Ohio
- Animal weight at initiation: 2.7 - 3.8 kg
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): animal room; controlled at 65-78°F
- Humidity (%): animal room; controlled at 35-70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

undiluted
TEST MATERIAL
- Amount applied: 0.5 mL per test side

Duration of treatment / exposure:

- 3 minutes
- and 1 hour

Observation period:

7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: no data
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with distilled water
- Time after start of exposure: 3 minutes and 1 hour

SCORING SYSTEM: table contained in OECD 405

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 3 minutes

Score:

4

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 hr

Score:

4

Max. score:

4

Remarks on result:

other: necrosis at all treated sites

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: necrosis, eschar formation

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: necrosis and eschar

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: eschar at al treated sites

Results 6

Irritation parameter:

erythema score

Basis:

mean

Time point:

7 d

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: eschar, exfoliation at all treated sites

Results 7

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 3 minutes

Score:

1

Max. score:

4

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 hr

Score:

1

Max. score:

4

Reversibility:

not reversible

Results 9

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

2.33

Max. score:

4

Reversibility:

not reversible

Results 10

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Score:

2

Max. score:

4

Results 11

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

1.33

Max. score:

4

Results 12

Irritation parameter:

edema score

Basis:

mean

Time point:

7 d

Score:

0.33

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Any other information on results incl. tables

Skin irritation and corrosion was tested in a study that was conducted similar to OECD 405 and under GLP conditions. 0.5 mL of DMBA was applied to two clipped skin sites on each of three Newzealand White rabbits. One site was covered for 3 minutes, while the second site covered (occlusive) for one hour. Following each exposure, the test sites were wiped and immediately graded for dermal reactions. Further readings were made at 1, 24, 48, 72 hours and 7 days post treatment. The findings were scored according the table contained in OECD 405.

 

N,N-dimethyl-n-butylamine produced high-grade erythema (score 4) and necrosis at one hour postdose at the three minute and 1-h exposure sites. The dermal responses progressed to eschar at all sites by 24 hours and persisted to test termination on study day 7.  Very slight to moderate swelling (score 1 - 2) was observed at exposure sites during the first 24 hours postdose. This diminished by test termination. Due to the severe effects no further animals were used. Thus, under the conditions of this test, N,N-dimethyl-n-butylamine produced skin corrosion at the three minute and one hour exposure sites (Siglin, 1989).

 

The study is considered to be valid and suitable for assessment.

 

Applicant's summary and conclusion

Interpretation of results:

Category 1A (corrosive)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

N,N-dimethyl-n-butylamine produced skin corrosion at the three minute and 1-h exposure sites.

Executive summary:

Skin irritation and corrosion was tested in a study that was conducted similar to OECD 405 and under GLP conditions. 0.5 mL of DMBA was applied to two clipped skin sites on each of three Newzealand White rabbits. One site was covered for 3 minutes, while the second site covered (occlusive) for one hour. Following each exposure, the test sites were wiped and immediately graded for dermal reactions. Further readings were made at 1, 24, 48, 72 hours and 7 days post treatment. The findings were scored according the table contained in OECD 405.

 

N,N-dimethyl-n-butylamine produced high-grade erythema (score 4) and necrosis at one hour postdose at the three minute and 1-h exposure sites. The dermal responses progressed to eschar at all sites by 24 hours and persisted to test termination on study day 7. 

Very slight to moderate swelling (score 1 - 2) was observed at exposure sites during the first 24 hours postdose. This diminished by test termination. Due to the severe effects no further animals were used.

Under the conditions of this test, N,N-dimethyl-n-butylamine produced skin corrosion at the three minute and one hour exposure sites (Siglin, 1989).

 

The study is considered to be valid and suitable for assessment.