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Registration Dossier
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EC number: 203-699-2 | CAS number: 109-73-9
Skin irritation / corrosion
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:
- 1 993
- 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
- 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
Constituent 1
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.
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