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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
1 min exposure instead of 4 h, combined with various post-exposure procedures of effect mitigation
Principles of method if other than guideline:
Method: Objective was to examine three first-aid measures to prevent/mitigate corrosion
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Butylamine
EC Number:
203-699-2
EC Name:
Butylamine
Cas Number:
109-73-9
Molecular formula:
C4H11N
IUPAC Name:
butan-1-amine
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): n-Butylamine
- Substance type: organic
- Physical state: liquid
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: C-00923

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 2.0 - 3.5 kg
- Housing:
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 21 (61 - 70 °F)
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12 / 12


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Dose 0.5 ml
Duration of treatment / exposure:
1 minute
Observation period:
1, 24, 72 h, 7 and 14 d post-application ( 14 d added, according to Protocol Amendment No. 1 of 02 March 1993)
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approx. 1 square inch
- % coverage: no data
- Type of wrap if used: gauze patch (8-ply)


REMOVAL OF TEST SUBSTANCE
Group 1 (no particular preventive measure)
Washing (if done): no, wiping with dray gauze
- Time after start of exposure: 1 min

Group 2 (rinsing)
Washing (if done): yes, 5 min distilled water (about 2 L per animal)
- Time after start of exposure: 1 min

Group 3
Washing (if done): yes, 1 min 5% (v/v) reagent-grade acetic acid/distilled water (about 0.5 L per animal)
- Time after start of exposure: 1 min

Group 4 (according to Protocol Amendment No. 1 of 02 March 1993)
Washing (if done): yes, 0.5 min distilled water (about 0.25 L per animal), 1 min PEG300 swabbing (gentle wiping) of each test site
(gauze moistend in PG300) and 3.5 min distilled water rinse (about 1.75 L per animal)
- Time after start of exposure: 1 min


SCORING SYSTEM: Draize numerical scoring system for quantitive grading of erythema and edema

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(no washing, Group 1)
Basis:
animal #1
Time point:
other: 1 hour - 14 d
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: immediate necrosis followed by eschar formation
Irritation parameter:
erythema score
Remarks:
(no washing, Group 1)
Basis:
animal #2
Time point:
other: 1 hour - 14 d
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: immediate necrosis followed by eschar formation
Irritation parameter:
erythema score
Remarks:
(no washing, Group 1)
Basis:
animal #3
Time point:
other: 1 hour - 14 d
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: immediate necrosis followed by eschar formation
Irritation parameter:
erythema score
Remarks:
Group 1
Basis:
mean
Remarks:
mean value for animal #1, #2, and #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other:
Remarks:
Maximum score of 4 at 24 h and 72 h.
Irritation parameter:
edema score
Remarks:
no washing, Group 1
Basis:
mean
Remarks:
mean value for animal #1, #2, and #3
Time point:
24 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
no washing, Group 1
Basis:
mean
Remarks:
mean value for animal #1, #2, and #3
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Remarks:
no washing, Group 1
Basis:
mean
Remarks:
mean value for animal #1, #2, and #3
Time point:
72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Not any of the washing measures taken could prevent the corrosive activity of n-butylamine.

Applicant's summary and conclusion

Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Conclusions:
Under the conditions of this test skin corrosive effects were already detectable after 1 min of exposure.
Executive summary:

In this dermal irritation study, 3 New Zealand White rabbits were exposed semiocclusively to 0.5 ml of the undiluted test substance on 1 square inch for 1 min. The test substance was removed by a) wiping with dray gauze; b) washing for 5 min distilled water (about 2 L per animal) or c) 1 min 5% (v/v) reagent-grade acetic acid/distilled water (about 0.5 L per animal).

Examinations of irritation/corrosion were performed 1, 24, 72 h and 7 and 14 d post-application. The effects were scored according to the Draize numerical scoring system for quantitive grading of erythema and edema. The exposure without washing produced immediate necrosis followed by eschar formation. The washing measures abated the corrosive activity of the test substance. The erythema score (without washing) was 4.0, the edema score was 2.3, and the effects were not fully reversible within 14 days. Under the conditions of this test skin the test substance was corrosive.