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Toxicological information

Skin irritation / corrosion

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 3 minutes
Score:
4
Max. score:
4
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
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hr
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: necrosis, eschar formation
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hr
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: necrosis and eschar
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hr
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: eschar at al treated sites
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: day 7
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: eschar, exfoliation at all treated sites
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 3 minutes
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hr
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hr
Score:
2.33
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hr
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hr
Score:
1.33
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 7 days
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.