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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Effects on fertility

Description of key information

A dermal reprotoxicity screening study in rats conducted according to OECD 422 in which no adverse effect was seen in any of the reproductive parameters examined at any dose.

Effect on fertility: via oral route
Endpoint conclusion:
no study available (further information necessary)
Quality of whole database:
A combined repeat dose and reproductive and developmental screening study (OECD 422) is currently being conducted on dilithium adipate.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Quality of whole database:
The lithium salts of dicarboxylic salts C6 - C10 have vapour pressures of <1.3 x 10(-8) Pa at 20°C and are exclusively manufactured in situ in base oil and the use of the grease forms will not result in aerosols, particles or droplets of an inhalable size.
Effect on fertility: via dermal route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
298.5 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
A key 28-day toxicity and reproductive toxicity screen, using the OECD 422 study design, was conducted in rats on monocarboxylate fatty acids C18 (unsaturated) lithium salts via dermal administration. This substance is a structural analogue by virtue of its chemical structure and therefore data have been read across from fatty acids C18 (unsaturated) lithium salts to members of the dilithium salts of dicarboxylic acids C6-10 category.
Additional information

The substances in the category are considered to be similar on the basis that they have common structures of a lithium ion varying only by the length of the fatty acid chain. As a result, it is expected that the substances will have similar, predictable properties. REACH Annex V, Entry 9, groups fatty acids and their potassium, sodium, calcium and magnesium salts, including C6 to C24, predominantly even-numbered, unbranched, saturated or unsaturated aliphatic monocarboxylic acids. Since published reviews do not distinguish between the properties of monocarboxylic or dicarboxylic acids as a category, then the same interpretation can be applied to the dicarboxylic acids. Due to the close structural similarity and the narrow range of carbon chain numbers covered in this category, effects on fertility are expected to be similar across the category. 

 

A key 28-day toxicity and reproductive toxicity screen, using the OECD 422 study design, was conducted in rats on monocarboxylate fatty acids C18 (unsaturated) lithium salts via dermal administration. Although this substance is not in the category, it is a structural analogue by virtue of its chemical structure and therefore read across from data on fatty acids C18 (unsaturated) lithium salts to members of the dilithium salts of dicarboxylic acids C6-10 category is considered to be justified – see read across justification.

 

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. 

 

Assuming a molecular weight of 288.4 g/mol for fatty acids C18-(unsaturated) lithium salt with a lithium content of 2.4% and a molecular weight of 158 g/mol for dilithium adipate with a lithium content of 8.8%, the values for fatty acid C18-(unsaturated) lithium salts have been recalculated for dilithium adipate, as the smallest substance in the category. The systemic NOAEL of 1089.75 mg/kg bw/day is equivalent to 26.2 mg Li/kg bw/day and thus 298.5 mg/kg bw/day dilithium adipate.

 

On the basis of the lack of reproductive and developmental toxicity when C18 (unsaturated) lithium salts was administered to rats being read across to members of the lithium salts of dicarboxylic acids C6-C10 category (see read across justification document), no classification for this endpoint is required.

 

Further testing is proposed or currently ongoing to support this conclusion; a combined repeat dose and reproductive and developmental screening study (OECD 422) is currently being conducted on dilithium adipate.

Effects on developmental toxicity

Description of key information
A dermal reprotoxicity screening study in rats conducted according to OECD 422 in which no adverse effect was seen in any of the reproductive/developmental parameters examined at any dose.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)
Quality of whole database:
A combined repeat dose and reproductive and developmental screening study (OECD 422) is currently being conducted on dilithium adipate and a pre-natal developmental toxicity study is proposed for dilithium sebacate.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Quality of whole database:
The lithium salts of dicarboxylic salts C6 - C10 have vapour pressures of <1.3 x 10(-8) Pa at 20°C and are exclusively manufactured in situ in base oil and the use of the grease forms will not result in aerosols, particles or droplets of an inhalable size.
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
298.5 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
A key 28-day toxicity and reproductive toxicity screen, using the OECD 422 study design, was conducted in rats on monocarboxylate fatty acids C18 (unsaturated) lithium salts via dermal administration. This substance is a structural analogue by virtue of its chemical structure and therefore data have been read across from fatty acids C18 (unsaturated) lithium salts to members of the dilithium salts of dicarboxylic acids C6-10 category.
Additional information

The substances in the category are considered to be similar on the basis that they have common structures of a lithium ion varying only by the length of the fatty acid chain. As a result, it is expected that the substances will have similar, predictable properties. REACH Annex V, Entry 9, groups fatty acids and their potassium, sodium, calcium and magnesium salts, including C6 to C24, predominantly even-numbered, unbranched, saturated or unsaturated aliphatic monocarboxylic acids. Since published reviews do not distinguish between the properties of monocarboxylic or dicarboxylic acids as a category, then the same interpretation can be applied to the dicarboxylic acids. Due to the close structural similarity and the narrow range of carbon chain numbers covered in this category, effects on developmental toxicity are expected to be similar across the category. 

 

A key 28-day 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 developmental or reproductive parameters evaluated. Based on these data, the NOAEL for reproductive and developmental toxicity was 1089.75 mg/kg/day. 

 

On the basis of the lack of developmental toxicity read across from relevant structural analogue (fatty acids C18 (unsaturated) lithium salts - see read across justification document), no classification for developmental organ toxicity is required for dilithium salts of dicarboxylic acids C6 -C10.

 

Further testing is proposed or currently ongoing to support this conclusion; a combined repeat dose and reproductive and developmental screening study (OECD 422) is currently being conducted on dilithium adipate.

Justification for classification or non-classification

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

Additional information