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Administrative data

Description of key information

Key study: Test method according to OECD 420. GLP study. Based on the read-across approach, the oral LD50 of the subtance was determined to be > 2000 mg/kg-bw.

Key study: Test method according to OECD 402. GLP Study. Based on the read-across approach, the dermal LD50 of the subtance was determined to be > 2000 mg/kg-bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
21 April 2010 - 01 June 2010
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
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
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 an analogue substance the acute oral median lethal dose (LD50) of the target substance in rat was estimated to be greater than 2000 mg/kg-bw.
Executive summary:

A study was performed to assess the acute oral toxicity of an analogue substance in the Wistar strain rat. The method was designed to meet the requirements of OECD Guideline 420 and GLP standards. The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight. Based on the read-across approach, the acute oral median lethal dose (LD50) of the target substance was determined to be greater than 2000 mg/kg-bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Only one study with an analogue substance available (Klimish score=1). Since the read-across approach is adopted, the target record has Klimish score=2.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
August 11-25 2010
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
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
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 from an analogue substance, the acute dermal median lethal dose (LD50) of the target subtance "Fatty acids, C14-22, ethylene esters, bisulfited, sodium salts" in the Wistar strain rat was determined to be greater than 2000 mg/kg-bw.
Executive summary:

A study was performed to assess the acute dermal toxicity of an analogue substance in the Wistar rat according to OECD Guidelines 402 and GLP standards. It was concluded that the acute dermal median lethal dose (LD50) of the test material was greater than 2000 mg/kg-bw. Based on the read-across approach, the dermal LD50 of the target substance "Fatty acids, C14-22, ethylene esters, bisulfited, sodium salts" was determined to be greater than 2000 mg/kg-bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Only one study with an analogue substance available (Klimish score=1). Since the read-across approach is adopted, the target record has Klimish score=2.

Additional information

In accordance to the column II of the Annex VIII of REACH Regulation, in addition to the oral route, for substances other than gases, an acute toxicity study shall be conducted for at least one other route. The dermal route was selected considering the physicochemical properties of the substance.

Justification for classification or non-classification

The substance is not classified for acute toxicity in accordance to CLP (Regulation (EC) No 1272/2008) since the oral and dermal LD50 were > 2000 mg/kg-bw.