Registration Dossier
Registration Dossier
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EC number: 203-710-0 | CAS number: 109-83-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 May 1980 - 16 May 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented report which meets the basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- BASF Test
- Principles of method if other than guideline:
- Method: BASF-Test. See further details in remarks on material and methods.
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-methylaminoethanol
- EC Number:
- 203-710-0
- EC Name:
- 2-methylaminoethanol
- Cas Number:
- 109-83-1
- Molecular formula:
- C3H9NO
- IUPAC Name:
- 2-(methylamino)ethan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Methylethanolamin
- Physical state: colorless liquid
- Analytical purity: 99 %
- Impurities (identity and concentrations): water: 0.5 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: M. Gaukler, Offenbach, Germany
- Weight at study initiation: 3.5 kg (mean)
- Diet: Ssniff K, standard diet for rabbits and guinea pigs, supplied by INTERMAST GmbH, Soest, Germany, ad libitum.
- Water: tap water ad libitum.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 3 min, 1h or 4 h
- Observation period:
- 8 days
- Number of animals:
- 4 h application: 1 male and 1 female
1 h application: 2 females
3 min appliction: 2 males - Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Lutrol and Lutrol/water (1:1).
- Time after start of exposure: 3 min, 1 h or 4 h.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- ; 3 min exposure
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 1.25
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: 72 h reading is missing
- Irritation parameter:
- edema score
- Remarks:
- ; 3 min exposure
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: 72 h reading is missing
- Irritation parameter:
- erythema score
- Remarks:
- ; 3 min exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: 72 h reading is missing
- Remarks:
- .
- Irritation parameter:
- edema score
- Remarks:
- ; 3 min exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: 72 h reading is missing
- Remarks:
- .
- Irritation parameter:
- erythema score
- Remarks:
- ; 1 h exposure
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: 72 h reading is missing
- Irritation parameter:
- edema score
- Remarks:
- ; 1 h exposure
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 2.25
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: 72 h reading is missing
- Irritation parameter:
- erythema score
- Remarks:
- ; 1 h exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: 72 h reading is missing
- Irritation parameter:
- edema score
- Remarks:
- ; 1 h exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: 72 h reading is missing
- Remarks:
- .
- Irritation parameter:
- erythema score
- Remarks:
- ; 4 h exposure
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- ; irreversible necrosis
- Remarks on result:
- other: 72 h reading is missing
- Irritation parameter:
- edema score
- Remarks:
- ; 4 h exposure
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- ; irreversible necrosis
- Remarks on result:
- other: 72 h reading is missing
- Irritation parameter:
- erythema score
- Remarks:
- ; 4 h exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: 72 h reading is missing
- Remarks:
- .
- Irritation parameter:
- edema score
- Remarks:
- ; 4 h exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: 72 h reading is missing
- Remarks:
- .
Any other information on results incl. tables
Mean erythema score after 24 and 48 (72 h reading is missing); (animal1/animal2)
| 24 h | 48 h | 72 h | mean | ||
| 3 min | 1/2 | 1/1 | -/- | 1/1.5 | |
| 1 h | 4/4 | 4/4 | -/- | 4/4 | |
| 4 h | 4/4 | 4/4 | -/- | 4/4 | |
Mean oedema score after 24 and 48 (72 h reading is missing); (animal1/animal2)
| 24 h | 48 h | 72 h | mean | ||
| 3 min | 0/2 | 0/0 | -/- | 0/1 | |
| 1 h | 2/3 | 2/2 | -/- | 2/2.5 | |
| 4 h | 3/2 | 2/2 | -/- | 2.5/2 | |
3 min exposure: 24 h after application slight erythema was observed and 1 animal showed distinct edema. At the end of the observation period of 8 days the irritations eased under scaling.
1 h exposure: immediately after exposure wide spanning erythema and distinct spanning oedema were observed. After 24 h parchment-like necrosis was noted. At the end of the observation period of 8 days, persistent edema and leathery-like necrosis was observed. This is considered to be a full thickness necrosis.
4 h exposure: immediately after exposure necrosis and wide spanning oedema was noted. At the end of the observation period of 8 days irreversible necrosis was observed. This is considered to be a full thickness necrosis.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- Test substance is corrosive
- Executive summary:
Test substance is corrosive
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