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Key value for chemical safety assessment

Effects on fertility

Description of key information

Key study: Test method OECD 422. GLP study. Based on the read-across approach from an analogue substance , the NOEL for reproductive toxicity was determined to be 1000 mg/kg-bw/day since no effects were observed on reprotoxicity parameters at the highest dose tested.

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
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:
NOEL
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No treatment-related effects were observed for any of the reproductive endpoints measured
Remarks on result:
other: Based on a read-across from an analogue substance for which NOEL = 1000 mg/kg-bw/day
Key result
Critical effects observed:
no
Key result
Dose descriptor:
NOEL
Generation:
F1
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, no treatment-related effects were observed for any of the reproductive endpoints measured
Remarks on result:
other: Based on a read-across from an analogue substance for which NOEL = 1000 mg/kg-bw/day
Key result
Critical effects observed:
no
Key result
Reproductive effects observed:
no
Conclusions:
Based on the read-across approach from the analogue substance rape oil, bisulfited, sodium salts, the NOEL for Fatty acids, C14 -22, ethylene esters, bisulfited sodium salts was considered to be > 1000 mg/kg bw/day since no effects were observed on reproductive screening parameters up to the highest dose tested.

 
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 for at least five weeks in accordance with OECD Guideline 422 under GLP conditions. No treatment-related effects were observed at any of the tested doses. There were no adverse effects of treatment on the reproductive/developmental screening parameters assessed. The NOEL for systemic and reproductive toxicity of the test substance was therefore considered to be > 1000 mg/kg-bw/day. Based on the read-across approach from the analogue substance rape oil, bisulfited, sodium salts, the NOEL for Fatty acids, C14 -22, ethylene esters, bisulfited sodium salts was considered to be > 1000 mg/kg bw/day since no effects were observed on reproductive screening parameters up to the highest dose tested.

 

Effect on fertility: via oral route
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 (Klimish =1) with an analogue substance available, since the read-across approach is adopted, the target record has Klimish = 2.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

Screening parameters are available (OECD 422). See 7.8.1.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the read-across approach, the substance is not classified for reproductive toxicity according to CLP (Regulation (EC) No 1271/2008) since no adverse effects were observed on reproductive and/or developmental parameters at a dose equivalent to 1000 mg/kg-bw/day.