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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Effects on fertility

Description of key information

A dermal reproductive toxicity screening study in rats was conducted according to OECD 422 and no adverse effects were seen in any of the reproductive/developmental parameters examined at any dose.

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 089.75 mg/kg bw/day
Study duration:
subacute
Species:
rat
Additional information

There are no data available for lithium isooctadecanoate. However, data on fatty acids C18 (unsaturated) lithium salts are considered to be appropriate for read across on the basis that the two substances have common structures of a lithium salt of C18 fatty acids. Lithium isooctadecanoate has a single methyl branch while fatty acids C18 (unsaturated) lithium salts contains unsaturated carbon-carbon double bonds. See IUCLID section 13 for read across justification. 

 

Fatty acids C18 (unsaturated) lithium salts is a UVCB substance consisting of C18 fatty acids with a range of degrees of unsaturation. Although a molecular weight has not been specified, as a lithium salt of C18 fatty acids, the molecular weight is expected to be comparable to that of lithium isooctadecanoate, varying by only a few hydrogens. Therefore, no calculations have been applied to convert the toxicity values which have been read across between the substances. 

  

A key toxicity and reproductive toxicity screen, using the OECD 422 study design, was conducted in rats on fatty acids C18 (unsaturated) lithium salts via dermal administration. The test material was administered at dose levels of 0, 100, 300 and 1000 mg/kg/day nominal, equating to 111.25, 345 and 1089.75 mg/kg/day by analysis, and were based on local dermal effects from a dose range finding study. There were no treatment-related effects at any dose level on any of the reproductive parameters evaluated in this study, or in any of the developmental parameters evaluated. Based on these data, the NOAEL for reproductive and developmental toxicity was 1089.75 mg/kg/day. The lack of reproductive and developmental toxicity when C18 (unsaturated) lithium salts was administered to rats can be read across to lithium isooctadecanoate, and no classification for this endpoint is required. 

 

A dermal reproductive toxicity screening study in rats was conducted according to OECD 422 and no adverse effects were seen in any of the reproductive parameters examined at any dose. This screening study provides relevant experimental data on this endpoint. The tested substance is appropriate for read across to lithium isooctadecanoate.

Effects on developmental toxicity

Description of key information

A dermal reproductive toxicity screening study in rats was conducted according to OECD 422 and no adverse effects were seen in any of the reproductive/developmental parameters examined at any dose.

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 adverse effect observed
Dose descriptor:
NOAEL
1 089.75 mg/kg bw/day
Study duration:
subacute
Species:
rat
Additional information

There are no data available for lithium isooctadecanoate. However, data on fatty acids C18 (unsaturated) lithium salts are considered to be appropriate for read across on the basis that the two substances have common structures of a lithium salt of C18 fatty acids. Lithium isooctadecanoate has a single methyl branch while fatty acids C18 (unsaturated) lithium salts contains unsaturated carbon-carbon double bonds. See IUCLID section 13 for read across justification. 

 

Fatty acids C18 (unsaturated) lithium salts is a UVCB substance consisting of C18 fatty acids with a range of degrees of unsaturation. Although a molecular weight has not been specified, as a lithium salt of C18 fatty acids, the molecular weight is expected to be comparable to that of lithium isooctadecanoate, varying by only a few hydrogens. Therefore, no calculations have been applied to convert the toxicity values which have been read across between the substances. 

 

A key toxicity and reproductive toxicity screen, using the OECD 422 study design, was conducted in rats on fatty acids C18 (unsaturated) lithium salts via dermal administration. The test material was administered at dose levels of 0, 100, 300 and 1000 mg/kg/day nominal, equating to 111.25, 345 and 1089.75 mg/kg/day by analysis, and were based on local dermal effects from a dose range finding study. There were no treatment-related effects at any dose level on any of the reproductive parameters evaluated in this study, or in any of the developmental parameters evaluated. Based on these data, the NOAEL for reproductive and developmental toxicity was 1089.75 mg/kg/day.  

 

The lack of developmental toxicity when C18 (unsaturated) lithium salts was administered to rats can be read across to lithium isooctadecanoate, and no classification for this endpoint is required. This study provides relevant experimental data on this endpoint and the data on the tested substance can be read across to lithium isooctadecanoate.

Justification for classification or non-classification

Not classified. No adverse reproductive or developmental toxicity effects observed. 

Additional information