Registration Dossier
Registration Dossier
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EC number: 294-589-3 | CAS number: 91744-27-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 Apr 1990 to 17 Apr 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: J. Europ. Commun. L 251, 27, 106-108
- Version / remarks:
- 19. September 1984
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glycerides, castor-oil mono-, di- and tri-
- EC Number:
- 294-589-3
- EC Name:
- Glycerides, castor-oil mono-, di- and tri-
- Cas Number:
- 91744-27-3
- Molecular formula:
- C21H40O5 – C57H104O9
- IUPAC Name:
- Glycerides, castor-oil mono-, di- and tri-
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name as cited in study report: Loxiol G11
- Charge: 0419-0-040
Test animals
- Species:
- rabbit
- Strain:
- other: Kleinrussen, Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach / Germany
- Age at study initiation: 19-23 months
- Weight at study initiation: ca. 2670 g
- Housing: Individually in Rabbit batteries of Fa. Heinkel, 7343 Kuchen/ Germany
- Diet: Altromin-Haltungsdiät 2023 Fa. Altromin GmbH, Lage/ Germany, ad libitum
- Water: Tapwater, 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:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL undiluted substance
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
The substance is equally distributed on a patch of 6 cm². The adhesive, air and watervapor permeable patch is fixed with an adhesive bandage.
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours. Reversibility of the reactions was checked for 7 days.
SCORING SYSTEM:
- Method of calculation: The scoring criteria were according to guidance 84/449/EWG (EC document L251/108):
Erythema and scaps
0 = No erythema
1 = Very mild erythema
2 = Well defined erythema
3 = Moderate to severe erythema
4 = Severe erythema (severe redness) to mild saps formation (thorough injury)
Edema
0 = No edema
1 = Very mild edema
2 = Mild edema (the borders are visible due to a clear swelling)
3 = Moderate edema (swelling around 1 mm)
4 = Severe oedema (swelling exceeding 1 mm and exceeding the site of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- All reactions were reversible in 7 days.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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