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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

The substance is not skin and eye irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Specific details on test material used for the study:
fatty acid methyl esters, (biodiesel)
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.
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.
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
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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Remarks:
in vivo existing study
Type of information:
experimental study
Remarks:
based on read-across
Adequacy of study:
key study
Study period:
From March 1, 1988 to March 15, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
The main components of the UVCB substance are fatty acids and fatty acid methyl esters. Biodiesel was used to assess the endpoint.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Fatty acids methyl esters (biodiesel)
Species:
rabbit
Vehicle:
unchanged (no vehicle)
Controls:
other: other eye
Amount / concentration applied:
single application of 0.1 g
Duration of treatment / exposure:
Single application
Observation period (in vivo):
1,6,24,48,72 hours after application
Number of animals or in vitro replicates:
4
Details on study design:
Approximately 24 hours before the application, the eyes of the rabbits were examined for their state of health. In addition to the visual assessment of the untreated eyes, the rabbits were examined with the aid of a 0.5% aqueous fluorescein sodium solution to determine whether the cornea was intact.
0.1 ml of a 0.5% fluorescein sodium solution was placed in the conjunctival sac of the eyes. 20 seconds later, the so treated eyes were rinsed thoroughly with lukewarm tap water. After that, the examination of the cornea was carried out to determine whether stains had adhered to the cornea. If there is no staining of the cornea, the epithelium is intact.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 6h
Score:
ca. 0.75
Max. score:
4
Reversibility:
fully reversible within: 18h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
ca. 0
Max. score:
4
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not irritating for eyes
Executive summary:

The substance was tested for primary eye irritation on rabbits by a single application of 0.1 g of the undiluited test product and permanent contact. Reaction on the cornea and iris were not observed. The conjunctival reactions were slight (redness) and disappeared within 24 after the apllication.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

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

Justification for classification or non-classification

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.