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EC number: 203-716-3 | CAS number: 109-89-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 28 July 2015
- Qualifier:
- according to guideline
- Guideline:
- other: International Maritime Organization (I.M.O.) criteria
- GLP compliance:
- yes
- Remarks:
- additionally Quality assurance statement available
Test material
- Reference substance name:
- Diethylamine
- EC Number:
- 203-716-3
- EC Name:
- Diethylamine
- Cas Number:
- 109-89-7
- Molecular formula:
- C4H11N
- IUPAC Name:
- diethylamine
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- 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
- Age at study initiation: young adult
- Weight at study initiation: 1.9- 2.2 kg
- Housing: individually housed in suspended stainless steel cages
- Diet: Agway Prolab Rabbit Ration, ad libitum
- Water: ad libitum
- Acclimation period: minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3 - 26.5 °C
- Humidity (%): 35-70 %
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 4/12/89 - 4/19/89
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 ml - Duration of treatment / exposure:
- 3 min
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: one and one-half inch square gauze patch
- Type of wrap if used: double layer of plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test article wiped from the site with gauze soaked in distilled water
- Time after start of exposure: 3 min
SCORING SYSTEM: Draize system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h - 48 - 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 2.2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- 7 days
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
Table 1. Erythema score (animal1/animal2/animal3):
| Exposure time | 3 min | 1 h | 24 h | 48 h | 72 h | 7 days |
| 3 min | 4/4/4 | 4/4/4 | 4/4/4 | 4/4/4 | 4/4/4 | 4/4/4 |
Table 2. Edema score
(animal1/animal2/animal3):
| Exposure time | 3 min | 1 h | 24 h | 48 h | 72 h | 7 days |
| 3 min | 1/1/1 | 2/2/2 | 2/3/3 | 2/2/2 | 2/2/1 | 0/0/0 |
The test substance produced dermal corrosion at all sites exposed to the test article. The dermal response was initially characterized by necrosis at the three minute scoring interval and progressed to eschar at one hour (2/3 rabbits) and 24 hours (3/3 rabbits). The eschar persisted throughout the remainder of the seven day study. A very slight edema was noted during the test period and diminished by test termination.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (corrosive) based on GHS criteria
- Conclusions:
- The test substance caused corossion of the rabbit skin under the tested conditions.
- Executive summary:
In a GLP compliant study the potential of the test item to cause skin corrosion/irritation was investigated with 3 New Zealand White rabbits. According to the International Maritime Organization (I.M.O.) criteria, 0.5 mL of the test substance was applied at the dorsal area of the trunk at a single site on the right flank after clipping. The exposure site was wrapped with a double layer of plastic wrap over the soaked gauze patch. After 3 min of exposure the plastic wrap and gauze patch were removed and washing of the residual test article was performed. Dermal reactions were observed at 3 min, 1 h, 24 h, 48 h, 72 h and 7 d after exposure initiation.
The test substance produced dermal corrosion at all sites exposed to the test article. The dermal response was initially characterized by necrosis at the three minute scoring interval and progressed to eschar at one hour (2/3 rabbits) and 24 hours (3/3 rabbits). The eschar persisted throughout the remainder of the seven day study. A very slight edema was noted during the test period and diminished by test termination.
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