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EC number: 213-195-4 | CAS number: 929-06-6
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-10-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to OECD 404 guideline and in compliance with the GLP Regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-(2-aminoethoxy)ethanol
- EC Number:
- 213-195-4
- EC Name:
- 2-(2-aminoethoxy)ethanol
- Cas Number:
- 929-06-6
- Molecular formula:
- C4H11NO2
- IUPAC Name:
- 2-(2-aminoethoxy)ethanol
- Details on test material:
- - Name of test material (as cited in study report): 6398-21-1
- Physical state: clear, colorless liquid
- Analytical purity: responsibility of the Sponsor
- Stability under test conditions: no apparent change in the physical state of the test article during administration
- Other: total amount submitted :1408.3g (materials and containers)/pH=10 (litmus paper)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hare-Marland, Hewitt, NJ
- Age at study initiation: adult
- Weight at study initiation: 2.504-2.865 kg
- Housing:Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the
Institute of Laboratory Animal Resources, National Research Council.
- Diet (e.g. ad libitum): Purina Rabbit Ration HF, ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum.
- Acclimation period: min.5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C±3°C (63-73°F)
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light):12h light, 12h dark
IN-LIFE DATES: From: To:
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: OECD 404: untreated area of the test animal serves as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL/site - Duration of treatment / exposure:
- 4h (upper: intact dorsal trunk)
24h (lower: intact and abraded dorsal trunk) - Observation period:
- 14d
- Number of animals:
- 6 (3M and 3F)
- Details on study design:
- TEST SITE
- Area of exposure: dorsal trunk (clipped free of fur)
- Type of wrap if used: rubber dam and an elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: 4 and 24h
SCORING SYSTEM: observation
Draize Evaluation of Dermal Irritation (Primary Irritation Index) and Modified Primary Irritation Index
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Score:
- 8
- Remarks on result:
- other: 8=severe dermal irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: 6/6
- Time point:
- other: 30min (4h exposure)
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- 14d observation
- Remarks on result:
- other: severe erythema, sloughing, fissuring and necrosis
- Irritation parameter:
- edema score
- Basis:
- animal: 6/6
- Time point:
- other: 30min (4h exposure)
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- 14d observation
- Remarks on result:
- other: severe edema, sloughing, fissuring and necrosis
- Irritation parameter:
- erythema score
- Basis:
- animal: 6/6
- Time point:
- other: 24h (24h exposure)
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- 14d observation
- Remarks on result:
- other: severe erythema, necrosis, sloughing and fissuring
- Irritation parameter:
- edema score
- Basis:
- animal: 6/6
- Time point:
- other: 24h (24h exposure)
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- 14d observation
- Remarks on result:
- other: severe edema, sloughing and fissuring
- Irritant / corrosive response data:
- irreversible severe erythema (including necrosis, sloughing, fissuring) and severe edema is observed 30 min after 4h exposure. The skin damage remained throughout the study (14d)
Applicant's summary and conclusion
- Conclusions:
- The test article was considered to be a severe dermal irritant at both 4 and 24 hour exposures.
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