Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion

Key study: Test method according to OECD 431. GLP Study. Based on the read-across approach the target substance "Fatty acis, C14 -22, ethylene esters, bisulfited sodium salts" is not considered corrosive to the skin.

Key study: Test method equivalent to OECD 439. GLP Study. Based on the read-across approach the target substance "Fatty acis, C14 -22, ethylene esters, bisulfited sodium salts" is not considered irritant to the skin.

Eye irritation/corrosion

Key study: Test procedure (in vitro) in accordance with generally accepted scientific standards and described in sufficient detail. GLP Study. Based on the read-across approach the target substance "Fatty acis, C14 -22, ethylene esters, bisulfited sodium salts" is not expected to cause severe ocular damage.

Key study: Test method according to OECD 405. GLP Study. Based on the read-across approach, the target substance "Fatty acis, C14 -22, ethylene esters, bisulfited sodium salts" is not classified for eye irritation according to the CLP Criteria.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from an analogue substance for which a guideline study (Klimish =1) is available.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format.
Reason / purpose:
read-across source
Irritation / corrosion parameter:
% tissue viability
Value:
108.1
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: Based on a read-across from an analogue substance.
Remarks:
Time point: 3 minutes.
Irritation / corrosion parameter:
% tissue viability
Value:
99.4
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: Based on a read-across from an analogue substance.
Remarks:
Time point: 60 minutes.
Irritation / corrosion parameter:
% tissue viability
Value:
105
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: Based on a read-across from an analogue substance.
Remarks:
Time point: 240 minutes.
Interpretation of results:
GHS criteria not met
Remarks:
CLP implementation.
Conclusions:
Based on a read-across from an analogue substance, it was determined that the target substance "Fatty acids, C14-22, ethylene esters, bisulfited sodium salts" is not corrosive to the skin.
Executive summary:

An in vitro study according to the OECD guideline 431 was conducted to determine the corrosivity potential of the test material "Rape oil, bisulfited, sodium salt". The study was conducter under GLP conditions and the EPISKINTMmodel was used. The test item was determined to be non-corrosive to the skin. Based on the read-across approach, the target substance " Fatty acids, C14-22, ethylene esters, bisulfited sodium salts" was also determined to be non-corrosive to the skin.

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from an analogue substance for which a guideline study (Klimish =1) is available.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format.
Reason / purpose:
read-across source
Irritation / corrosion parameter:
% tissue viability
Remarks:
Mean
Run / experiment:
Test item
Value:
102.2
Negative controls validity:
valid
Remarks:
100 %
Positive controls validity:
valid
Remarks:
27.9 %
Remarks on result:
other: Based on a read-across from an analogue substance.
Interpretation of results:
GHS criteria not met
Remarks:
CLP implementation.
Conclusions:
Based on a read-across from an analogue substance, the target substance "Fatty acids, C14-22, ethylene esters, bisulfited sodium salts" is determined to be a non-irritant to the skin.
Executive summary:

An in vitro study using the EPISKIN reconstituted human epidermis model was conducted to determine the skin irritation potential of the test material "Rape oil, bisulfited, sodium salt". The study was conducted under GLP conditions. The test item was determined to be non-irritant to the skin. Based on the read-across approach, the target substance "Fatty acids, C14-22, ethylene esters, bisulfited sodium salts"was also determined to be non-irritant to the skin.

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

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from an analogue substance for which a guideline study (Klimish =1) is available.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format.
Reason / purpose:
read-across source
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Based on a read-across from an analogue substance.
Interpretation of results:
GHS criteria not met
Remarks:
CLP Implementation.
Conclusions:
Based on the read-across approach from the analogue substance "Rape oil, bisulfited, sodium salt", the substance "Fatty acids, C14-22, ethylene esters, bisulfited sodium salts" was determined to not irritating according to the CLP Criteria.
Executive summary:

An acute eye irritation/corrosion study was performed with the analogue substance "Rape oil, bisulfited, sodium salt" in rabbit according to OECD Guideline 405. A single application of the test material to the non-irrigated eye of two rabbits produced moderate conjuctival irritation. Both treated eyes appeared normal at the 48 -Hour observation. The test material is not classified for eye irritation according to the CLP Criteria. Based on the read-across approach from the analogue substance "Rape oil, bisulfited, sodium salt", the target substance "Fatty acids, C14-22, ethylene esters, bisulfited sodium salts" was determined to be not irritating to the eyes according to the CLP Criteria.

Endpoint:
eye irritation
Remarks:
other: ex-vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from an analogue substance for which a guideline study (Klimish =1) is available.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format.
Reason / purpose:
read-across source
Irritation parameter:
cornea opacity score
Remarks:
Opacy
Value:
0
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: Based on a read-across from an analogue substance.
Interpretation of results:
GHS criteria not met
Remarks:
CLP Implementation.
Conclusions:
Based on a read-across from an analogue substance, the target substance "Fatty acids, C14-22, ethylene esters, bisulfited, sodium salts" is not considered to be an ocular irritant.
Executive summary:

A study was performed to assess the ocular irritancy potential of the analogue substance "Rape oil, bisulfited, sodium salts" in the rabbit following application onto the cornea of the enucleated eye. Following assessment of the data for all endpoints, the test material was considered unlikely to have the potential to cause severe ocular irritancy in vivo. Based on the read-across, the target substance "Fatty acids, C14-22, ethylene esters, bisulfited, sodium salts" is not expected to cause severe ocular irritancy.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the read-across approach, the substance is not classified for skin irritation according to CLP (Regulation (EC) No 1272/2008): the mean cell viability of human skin models was not affected by the substance.

Based on the available data, the substance is not classified for eye irritation according to the CLP Regulation (EC) No 1272/2008: the conjunctival irritation was resolved after 48 hours and the mean scores for corneal opacity, iritis, conjuntival redness and chemosis following grading at 24, 48 and 72 h were below the CLP criteria for reversible eye effects.