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Administrative data

Description of key information

Key study: Test method according to OECD 422. GLP Study. Based on a read-across from an analogue substance, the NOAEL for "Fatty acids, C14 -22, ethylene esters, bisulfited, sodium salts" is 1000 mg/kg-bw/day for general systemic toxicity.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: oral
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
Key result
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: overall effects including: clinical signs; mortality; body weight; food consumption; food efficiency; water consumption; haematology; clinical chemistry; gross pathology; organ weights; histopathology
Remarks on result:
other: Based on a read-across from an analogue substance.
Key result
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: reproduction
Remarks on result:
other: Based on a read-across from an analogue substance.
Key result
Critical effects observed:
no

Reproductive Performance: there were no treatment-related effects on any observed reproductive endpoint.

Conclusions:
Based on the read-across approach from the analogue substance "Rape oil, bisulfited, sodium salts", the subacute NOAEL for "Fatty acids, C14 -22, ethylene esters, bisulfited sodium sats" was determined to be 1000 mg/kg bw/day for general systemic toxicity.
Executive summary:

The systemic toxic potential and effects on reproduction were assessed in rats following oral administration of the analogue substance "Rape oil, bisulfited, sodium salts" in accordance with OECD Guideline 422 and GLP standards. The oral administration of the test item to rats by gavage at a maximum dose level of 1000 mg/kg/day did not result in any toxicologically significant effects of treatment. The minor effects detected in this study were not considered to represent an adverse effect of treatment; therefore a ‘No Observed Adverse Effect Level’ (NOAEL) was established at 1000 mg/kg/day for systemic toxicity. No treatment-related effects were detected for reproductive performance, hence a ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 1000 mg/kg/day. Based on the read-across approach from the analogue substance "Rape oil, bisulfited, sodium salts, the subacute NOAEL for "Fatty acids, C14 -22, ethylene esters, bisulfited sodium sats" was determined to be 1000 mg/kg bw/day for general systemic toxicity..

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Only one study available (Klimish score=1) with an analogue substance. Since the read-across is applied, the target information has Klimish=2.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on a read-across, the 28 -day NOAEL (oral, rats) was determined to be 1000 mg/kg-bw/day, therefore, the substance is not classified for STOT-RE according to CLP (Regulation (EC) No 1272/2008), since the NOAEL is higher than the guidance value for Category 2 classification adjusted for a 28 -day duration study (i.e. 300 mg/kg-bw/day).