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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo existing study
Type of information:
experimental study
Remarks:
read-across from supporting subastance (analogue or surrogate)
Adequacy of study:
key study
Study period:
From February 11, 1988 to February 25, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well described study conducted to recognized international test guidelines. Non GLP studie

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18 and C18-unsatd., Me esters
EC Number:
267-015-4
EC Name:
Fatty acids, C16-18 and C18-unsatd., Me esters
Cas Number:
67762-38-3
Molecular formula:
UVCB substance, not univocal molecular formula available
IUPAC Name:
UVCB substance, no IUPAC name avalilable Chemical name: C16-C18 and C18 unsaturated alkyl carboxylic acids methyl esters
Test material form:
liquid: viscous
Details on test material:
- Name of test material: Fatty acids C16-C18 and C18 unsaturated methyl esters
- Physical state: light yellow liquid
- Analytical purity: 79.01% (sum of methylesters of C18 fatty acids)
- Certificate of analysis reference EST_P77220_0806159_080814_13
- Water solubility: < 0.13 mg/L (20°C) according to SDS
- Relative density at 20°C: 890 kg/m^3 according to SDS
Specific details on test material used for the study:
fatty acid methyl esters, (biodiesel)

Test animals

Species:
rabbit
Details on test animals or test system and environmental conditions:
Male adult rabbits of the tribe Little Russian, Chbb: HM, breeder Fa. Thomae, Biberach / D.
The acclimatization time of the animals was at least 1 week under experimental conditions, but without treatment.
Only animals with healthy skin were used.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
The substance was tested in undiluted form for primary skin irritation. 0.5 g of the product was applied to a 2.5 cm x 2.5 cm linen lobe
Duration of treatment / exposure:
4 hours
Observation period:
Post observation of 3 days
Number of animals:
4 adult males
Details on study design:
Experimental procedure
Approximately 24 hours before the application, the back skin of the test animals was shaved and the skin was examined for its state of health before the exposure. Only animals with uninjured skin were used.
The substance was tested in undiluted form for primary skin irritation. 0.5 g of the product was applied to a 2.5 cm x 2.5 cm linen lobe and spread evenly on the linen lobe. The linen lobes were placed on the shaved back skin of the rabbits, covered with a larger plastic sheet fixed at the edges with adhesive plaster, and then secured with acrylicastic tape for secure fixation and occlusive coverage.
The contact time was 4 hours. During this time, the experimental animals were kept in special boxes, which prevented a shift of the linen lobes on the dorsal skin.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1h
Score:
ca. 0.75
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1h
Score:
ca. 0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
Not irritating
Executive summary:

The substance Edenor ME Ruckstand II was tested for primary irritation under occlusive conditions on the shaved back skin of 4 rabbits. After a contact time of 4 hours the skin reaction were evaluated. Three of four animals had a slight skin redness one hour after application. The redness completely disappear after 24 hours. The substance is considered not irritating