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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo existing study
Type of information:
experimental study
Remarks:
based on read across
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:
comparable to guideline study with acceptable restrictions
Justification for type of information:
The main components of the UVCB substance are fatty acids and fatty acids methyl esters. Biodiesel was used to assess the endpoint.
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
The substance is not skin and eye irritating
Endpoint conclusion:
no adverse effect observed (not irritating)
Endpoint conclusion:
no adverse effect observed (not irritating)

The substance is not skin and eye irritating.

There is no structural alerts or physical chemical property that can support a risk for respiratory tract. Due to the low vapour pressure of the substance, the inhalatory route is of minimal relevance

No classification for skin irritation is warranted under 67/548/EEC or Regulation 1272/2008.

No classification for eye irritation is warranted under 67/548/EEC or Regulation 1272/2008.

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 / Fa. Thomae, Biberach / D.

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

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritating
Executive summary:

The substance 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