Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

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 study available
Additional information

There no existing reproductive toxicity study for the registered substance.  As such, read-across to support the registration of 9-Octadecenoic acid (Z)-, monoester with 1,2,3-propanetriol ester with boric acid using hydrolytic and metabolic breakdown products is considered to be acceptable. Additionally, a repeat dose dermal study (similar to OECD 410) on a similar borated material (CASRN 91052-28-7) is included for consideration.

The registered substance is manufactured in highly refined mineral oil and further diluted with lubricant additives and base oil in finished fluid. The oil and additives are expected to stabilize the substance to hydrolysis and hydrolysis to boric acid is not expected to occur under normal conditions of handling and use. However, under undesired hydrolytic conditions, including aqueous environments, the borated ester will quickly convert to boric acid. Exposure to boric acid is not expected under normal use conditions to the worker or consumer. The registered substance does not contain detectable levels of residual boric acid. The hazard communications requirement for classification is based on the constituents known to be present under normal conditions of use. Assuming worst case scenarios, if the registered substance were to hydrolyze completely, the only relevant route of exposure to workers is dermal and the dermal absorption of boric acid in humans is relatively low at <0.3% (Draize and Kelley, 1959). Animal ingestion studies in several species, at high doses, indicate that boric acid causes reproductive and developmental effects. The doses are many times in excess of those which humans would be exposed to. A human study of occupational exposure to borates showed no adverse effect on reproduction (Whorton et al., 1994). Therefore, the registered substance is not classified for reproductive toxicity based on read-across and exposure considerations.

Effects on developmental toxicity

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
Additional information

There no existing reproductive toxicity study for the registered substance.  As such, read-across to support the registration of 9-Octadecenoic acid (9Z)-, monoester with 1,2,3-propanetriol ester with boric acid using hydrolytic and metabolic breakdown products is considered to be acceptable. Additionally, a repeat dose dermal study (similar to OECD 410) on a similar borated material (CASRN 91052-28-7) is included for consideration.

The registered substance is manufactured in highly refined mineral oil and further diluted with lubricant additives and base oil in finished fluid. The oil and additives are expected to stabilize the substance to hydrolysis and hydrolysis to boric acid is not expected to occur under normal conditions of handling and use. However, under undesired hydrolytic conditions, including aqueous environments, the borated ester will quickly convert to boric acid. Exposure to boric acid is not expected under normal use conditions to the worker or consumer. The registered substance does not contain detectable levels of residual boric acid. The hazard communications requirement for classification is based on the constituents known to be present under normal conditions of use. Assuming worst case scenarios, if the registered substance were to hydrolyze completely, the only relevant route of exposure to workers is dermal and the dermal absorption of boric acid in humans is relatively low at <0.3% (Draize and Kelley, 1959). Animal ingestion studies in several species, at high doses, indicate that boric acid causes reproductive and developmental effects. The doses are many times in excess of those which humans would be exposed to. A human study of occupational exposure to borates showed no adverse effect on reproduction (Whorton et al., 1994). Therefore, the registered substance is not classified for reproductive toxicity based on read-across and exposure considerations.

Justification for classification or non-classification