Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.172 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
AF for intraspecies differences:
5
Justification:
Standard worker AF
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Inhalation toxicity

 

The substance has not been tested by the inhalation route. Lithium isooctadecanoate is exclusively produced and used directly in grease form. It has a vapour pressure of less than 10 E-10 Pa and a melting point of 193°C, so the potential for the generation of inhalable forms is low, also the use of the grease forms will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. However, although no substance specific intrinsic inhalative toxicity is expected, generally accepted OELs derived for inert (nuisance) dust/particulates not otherwise classified (PNOCs) of 10 mg/m3 for chronic and 20 mg/m3 for acute exposure to inhalable dust and of 3 mg/m3 for chronic and of 6 mg/m3 for acute exposure to alveolar (respirable) dust are applicable and must be adhered to, to avoid non-specific inhalative dust toxicity. By adherence to the general dust limits, the risk to humans can be considered to be sufficiently controlled. In accordance with ECHA REACH TGD R.8, the general dust limits are used as DNEL surrogate. Therefore, lithium isooctadecanoate is not considered to be hazardous. 

 

Dermal toxicity

 

There are no data available for lithium isooctadecanoate. However, a combined short-term repeat dose and reproductive toxicity screening study via dermal route was conducted on fatty acids C18 -(unsaturated) lithium salts and the results have been read across to lithium isooctadecanoate. 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.

 

The experimental results from the repeated dose dermal toxicity study on fatty acids C18 (unsaturated) lithium permits consideration of long term local effects on the skin. The NOAEL for this effect was 111.25 mg/kg/day, which converts to 0.86 mg/cm2 based on the area of rat skin exposed in the subacute study (average weight of the rats in the study was 311g, the body surface area was calculated as being approximately 9.1 x bw(g)0.66, and the approximate surface area exposed was 10%).Using a standard worker assessment factor of 5, the DNEL was calculated to be 0.172 mg/cm2.

 

No systemic effects were observed at the highest dose of fatty acids C18 -(unsaturated) lithium salts tested so the NOAEL was determined to be 1089.75 mg/kg bw/day.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.086 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
AF for intraspecies differences:
10
Justification:
Standard AF for general population
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Inhalation toxicity

 

The substance has not been tested by the inhalation route. Lithium isooctadecanoate is exclusively produced and used directly in grease form. It has a vapour pressure of less than 10 E-10 Pa and a melting point of 193°C, so the potential for the generation of inhalable forms is low, also the use of the grease forms will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. However, although no substance specific intrinsic inhalative toxicity is expected, generally accepted OELs derived for inert (nuisance) dust/particulates not otherwise classified (PNOCs) of 10 mg/m3 for chronic and 20 mg/m3 for acute exposure to inhalable dust and of 3 mg/m3 for chronic and of 6 mg/m3 for acute exposure to alveolar (respirable) dust are applicable and must be adhered to, to avoid non-specific inhalative dust toxicity. By adherence to the general dust limits, the risk to humans can be considered to be sufficiently controlled. In accordance with ECHA REACH TGD R.8, the general dust limits are used as DNEL surrogate. Therefore, lithium isooctadecanoate is not considered to be hazardous. 

 

Dermal toxicity

 

There are no data available for lithium isooctadecanoate. However, a combined short-term repeat dose and reproductive toxicity screening study via dermal route was conducted on fatty acids C18 -(unsaturated) lithium salts and the results have been read across to lithium isooctadecanoate. 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.

 

The experimental results from the repeated dose dermal toxicity study on fatty acids C18 (unsaturated) lithium permits consideration of long term local effects on the skin. The NOAEL for this effect was 111.25 mg/kg/day, which converts to 0.86 mg/cm2 based on the area of rat skin exposed in the subacute study (average weight of the rats in the study was 311g, the body surface area was calculated as being approximately 9.1 x bw(g)0.66, and the approximate surface area exposed was 10%). Using a standard general population assessment factor of 10, the DNEL was calculated to be 0.086 mg/cm2.

 

No systemic effects were observed at the highest dose of fatty acids C18 -(unsaturated) lithium salts tested so the NOAEL was determined to be 1089.75 mg/kg bw/day.