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Toxicological information

Skin irritation / corrosion

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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:
1984
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

Constituent 1
Reference substance name:
Reaction products resulting from the esterification of C18 unsaturated fatty acid with glycerol and glycerol oligomers
Molecular formula:
not applicable (UVCB)
IUPAC Name:
Reaction products resulting from the esterification of C18 unsaturated fatty acid with glycerol and glycerol oligomers
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.