Registration Dossier
Registration Dossier
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EC number: 603-931-6 | CAS number: 135800-37-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 9th, 1989 to May, 16th 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : occlusive exposition, analytical purity of test material not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C8-16(even numbered), 2-ethylhexyl esters
- EC Number:
- 603-931-6
- Cas Number:
- 135800-37-2
- Molecular formula:
- C16H32O2 to C24H48O2
- IUPAC Name:
- Fatty acids, C8-16(even numbered), 2-ethylhexyl esters
- Details on test material:
- - Name of test material (as cited in study report): only trade name reported
- Physical state: liquid, clear
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Kleinrussen, Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Germany
- Age at study initiation: 8-12 months
- Weight at study initiation: approx. 2620 g
- Diet: ad libitum (Altromin-Haltungsdiat 2023)
- Water: ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: untreated site of the same animal served as control
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1h, 24h, 48h, 72h and 7 days
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: inert plastic foil fixed with an adhesive patch (Leukosilk) and a special gauze bandage (Acrylastic)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No Data
SCORING SYSTEM: According to the council directive 84/449/EEC
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 102
- Time point:
- other: average 24, 48 and 72h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- erythema score
- Basis:
- animal: 128
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- erythema score
- Basis:
- animal: 129
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- erythema score
- Basis:
- animal: 130
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- animal: 102
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- edema score
- Basis:
- animal: 128
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal: 129
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal: 130
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
Any other information on results incl. tables
Erythema Score
Animal Number |
1 h |
24 h |
48 h |
72 h |
7 d |
102 |
1 |
1 |
1 |
2 |
0 |
128 |
1 |
1 |
0 |
1 |
0 |
129 |
1 |
1 |
0 |
1 |
0 |
130 |
1 |
0 |
0 |
1 |
0 |
Edema Score
Animal Number |
1 h |
24 h |
48 h |
72 h |
7 d |
102 |
1 |
1 |
0 |
0 |
0 |
128 |
0 |
0 |
0 |
0 |
0 |
129 |
2 |
0 |
0 |
0 |
0 |
130 |
0 |
0 |
0 |
0 |
0 |
The test substance, when administered to rabbit skin for 24h, caused only slight irritations that were fully reversible within 7 days. According to DSD and CLP the test substance has not to be classified.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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