Registration Dossier
Registration Dossier
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EC number: 905-898-6 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2',2''-nitrilotriethanol
- EC Number:
- 203-049-8
- EC Name:
- 2,2',2''-nitrilotriethanol
- Cas Number:
- 102-71-6
- Molecular formula:
- C6H15NO3
- IUPAC Name:
- 2,2',2''-nitrilotriethanol
- Details on test material:
- - Name of test material (as cited in study report): Triethanolamin T 85
- Composition of test material, percentage of components: 85 % Triethanolamine and 15 % Diethanolamine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach (Germany)
- Mean weight at study initiation: males: 2.34 kg; females 2.41 kg
- Housing: individual
- Diet: 130 g/day (Ovator Solikanin 4 mm, Muskator-Werke, Düsseldorf, Germany)
- Water: 250 ml tap water/day
- Acclimatisation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 72 hours
- Number of animals:
- 1 male and 2 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lutrol, water (1:1)
- Time after start of exposure: 4 hrs
SCORING SYSTEM: according to Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
Any other information on results incl. tables
Readings |
Animal |
Exposure period: 4 h |
||
Erythema |
Edema |
Additional findings |
||
4 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
|
|
3 |
0 |
0 |
|
|
24 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
|
|
3 |
0 |
0 |
|
|
48 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
|
|
3 |
0 |
0 |
|
|
72 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
|
|
3 |
0 |
0 |
|
|
Mean 24, 48, 72 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
|
|
3 |
0 |
0 |
|
|
Mean 24, 48, 72 h |
1-3 |
0 |
0 |
|
(Calculation of the mean according to 83/467/EEC criteria of July 29th, 1983)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Classification: not irritating
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