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EC number: 248-122-5 | CAS number: 26942-95-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 Jan - 24 Jan 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study. Lack of details on test material.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 1981
- Deviations:
- yes
- Remarks:
- lack of details on test material
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,2,3-propanetriyl triisooctadecanoate
- EC Number:
- 248-122-5
- EC Name:
- 1,2,3-propanetriyl triisooctadecanoate
- Cas Number:
- 26942-95-0
- Molecular formula:
- C57H110O6
- IUPAC Name:
- 1,2,3-Propanetriyl tris(16-methylheptadecanoate)
- Details on test material:
- - Name of test material (as cited in study report): [trade name] glycerol tri-isostearate
- Physical state: thick yellow liquid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage des Feuilletas, Campet Lamolere, France
- Weight at study initiation: 2 ± 0.2 kg
- Housing: individually in stainless steel cages (61 x 46 x 34 cm) with grid floor. The door of each cage was equipped with a feeding device and a 1000 mL drinking bottle.
- Diet: UAR 112, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the opposite flank of the same animals was treated with dist. water
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 8 days
Reading time points: 1, 24, 48 and 72 h and 5, 6, 7 and 8 days - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: ca. 6 cm²
- Type of wrap if used: the test material was applied on a Codex hydrophilic eight layer gauze (2.5 x 2.5 cm) which was then laid down on the skin. The gauzes were kept in contact with the skin using a hypoallergenic microporous adhesive strip (50 mm wide) and held in place with a stretchable band wraped around the animal.
SCORING SYSTEM: Draize scoring system
OBSERVATIONS
Any behavioural disorder, any modification in the vegetative reactions or in feeding and drinking consumption of the animals were duly recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Very slight erythema was observed in 2 animals at 1 h after patch removal, which persisted until Day 5 and 6, respectively.
No edema was noted in any animal at any reading time point.
Very slight loss of skin elasticity and dryness were observed (no further details given). - Other effects:
- No further local or systemic effects were reported.
Any other information on results incl. tables
Table 1. Results of skin irritation study
Observation time |
Rabbit no. |
|||||
1 |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
1 |
0 |
1 |
0 |
0 |
0 |
24 h |
1 |
0 |
1 |
0 |
0 |
0 |
48 h |
1 |
0 |
1 |
0 |
0 |
0 |
72 h |
1 |
0 |
1 |
0 |
0 |
0 |
5 days |
1 |
0 |
1 |
0 |
0 |
0 |
6 days |
0 |
0 |
1 |
0 |
0 |
0 |
7 days |
0 |
0 |
0 |
0 |
0 |
0 |
8 days |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value 24+48+72 h |
1 |
0 |
1 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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