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EC number: 943-350-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-10-23 to 1984-10-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Complete guideline conform study report available. Study is performed under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction products resulting from the esterification of C18 unsaturated fatty acid with glycerol and glycerol oligomers
- EC Number:
- 943-350-8
- Molecular formula:
- not applicable (UVCB)
- IUPAC Name:
- Reaction products resulting from the esterification of C18 unsaturated fatty acid with glycerol and glycerol oligomers
Constituent 1
- Specific details on test material used for the study:
- - Chemical name: Diglycerinsesquioleat
- Purity: about 100 %
- Lot No. FMFP355
- Appearance: yellow liquid
- Storage: In the dark at about 22°C
- Solubility: not soluble in water, soluble in most organic solvents
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- None
Any other information on results incl. tables
Table 1. Skin irritation/ corrosion test: Scoring results (acc. to Draize)
Time after treatment |
30 – 60 min. |
24 hrs |
48 hrs |
72 hrs |
||||||||
Animal no. |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the skin.
- Executive summary:
In order to evaluate the dermal irritant/corrosive potential of the test substance an in vivo test in rabbits was performed in 1984 which was in accordance to guideline OECD 404. 24 hours prior to treatment the animals back was shaved to receive a skin area of about 10 x10 square centimeters for treatment. Only animals with intact skin were chosen for the test. The 3 animals were each treated with 0.5 mL test substance per animal on the right flank, whereas the left side serves as control. The treated area was covered by an semi-occlusive bandage and fixed with a non-irritant tape for 4 hours. After these 4 hours, the bandage was removed and the skin washed with lukewarm water to remove remaining test substance. Mortality and clinical signs of toxicity were observed once daily. The skin was assessed for edema, eschar formation or erythema according to Draize, 60 minutes, 24, 48 and 72 hours after removing of bandage. No mortality occurred. No clinical signs of toxicity were observed. The overall mean scoring value is 0 for erythema and edema formation.
Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the skin.
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