Dihydro-2,2-dioctyl-6H-1,3,2-oxathiastannin-6-one

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

By read-across to Dioctyltin oxide, Dioctyltin mercaptopropionate is considered to have no relevant effects on fertility.

After correction for molecular weight, the NOAEL values from read-across to Dioctyltin oxide were 0.4 -0.5 mg/kg bw/day for male animals and 0.4-0.6 mg/kg bw/day for female animals and the NOEAL for effects on reproductive parameters (mean duration of gestation, post-implantation loss, total number of still born pups) was determined to be 31 mg/kg diet (1.7 mg/kg bw/day).

Read-across to structurally similar substance DOTO (Dioctyltin oxide)

Under the conditions of a screening test on reproductive toxicity according to OECD guideline 422 the NOAEL for diooctyltin oxide for parental effects which were determined by thymus toxicity and in addition in the females by severe effects on body weight/body weight gain and food consumption during pregnancy and lactation was concluded to be the lowest group tested, 5 mg/ kg diet which was equivalent to 0.3-0.4 mg/kg bw/day for male animals and 0.3-0.5 mg/kg bw/day for female animals. The NOAEL for effects on reproductive parameters (mean duration of gestation, post-implantation loss, total number of still born pups) was determined to be 25 mg/kg diet, equivalent to 1.5-1.7 mg/kg bw/day in males and 1.4-2.4 mg/kg bw/day in female animals. As the effects on reproductive parameters were clearly limited to parental toxic dose levels, the reproductive toxicity of dioctyltin oxide is considered an unspecific secondary effect of parental systemic toxicity and therefore no classification is required.

Effect on fertility: via oral route

Endpoint conclusion:

adverse effect observed

Dose descriptor:

NOAEL

1.7 mg/kg bw/day

Study duration:

subacute

Species:

rat

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

Read-across to structurally similar substance: DOTO (Dioctyltin oxide)

The toxicological effects of DOTO and possible effects on reproduction were assessed in a repeated dose toxicity and reproductive and developmental screening study in rats. The study was performed in accordance with GLP and to the standardised guideline OECD 422. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

Based on the effects noted in the thymus in both male and female rats and in addition in females severe effects on body weight/ body weight gain and food consumption during pregnancy and lactation in the 25 mg/kg diet groups, the NOAEL for parental toxicity was concluded to be the lowest group tested, 5 mg/kg diet which was equivalent to 0.3-0.4 mg/kg bw/day for male animals and 0.3-0.5 mg/kg bw/day for female animals.

Based on effects on reproductive parameters (mean duration of gestation, post-implantation loss, total number of still born pups) the NOAEL for reproductive toxicity was determined to be 25 mg/kg diet, equivalent to 1.5-1.7 mg/kg bw/day in males and 1.4-2.4 mg/kg bw/day in female animals. All these non-specific effects are considered likely to be related to maternal toxicity (severe effects on body weight/body weight gain and food consumption during pregnancy and lactation; thymus effects). Therefore no classification for reproductive toxicity is required.

After correction for molecular weight, the NOAEL values from read-across to Dioctyltin oxide were 0.4 -0.5 mg/kg bw/day for male animals and 0.4-0.6 mg/kg bw/day for female animals and the NOAEL for effects on reproductive parameters (mean duration of gestation, post-implantation loss, total number of still born pups) was determined to be 31 mg/kg diet (1.7 mg/kg bw/day).

Effects on developmental toxicity

Description of key information

By read-across to Dioctyltin oxide, Dioctyltin mercaptopropionate is considered to have no relevant effects on developmental toxicity.

After correction for molecular weight, the NOAEL values from read-across to Dioctyltin oxide were 0.4 -0.5 mg/kg bw/day for male animals and 0.4-0.6 mg/kg bw/day for female animals and the NOEAL for effects on reproductive parameters (mean duration of gestation, post-implantation loss, total number of still born pups) was determined to be 31 mg/kg diet (1.7 mg/kg bw/day).

Read-across to structurally similar substance DOTO (Dioctyltin oxide)

Under the conditions of a screening test on reproductive toxicity according to OECD guideline 422, the NOAEL for diooctyltin oxide for parental effects which were determined by thymus toxicity and in addition in the females by severe effects on body weight/body weight gain and food consumption during pregnancy and lactation was concluded to be the lowest group tested, 5 mg/ kg diet which was equivalent to 0.3-0.4 mg/kg bw/day for male animals and 0.3-0.5 mg/kg bw/day for female animals. The NOEAL for effects on reproductive parameters (mean duration of gestation, post-implantation loss, total number of still born pups) was determined to be 25 mg/kg diet, equivalent to 1.5-1.7 mg/kg bw/day in males and 1.4-2.4 mg/kg bw/day in female animals. As the effects on reproductive parameters were clearly limited to parental toxic dose levels, the reproductive toxicity of dioctyltin oxide is considered an unspecific secondary effect of parental systemic toxicity. Therefore no classification for reproductive toxicity is required.

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1.7 mg/kg bw/day

Study duration:

subacute

Species:

rat

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

Read-across to structurally similar substance: DOTO (Dioctyltin oxide)

The developmental effects of DOTO were assessed in a repeated dose toxicity and reproductive and developmental screening study in rats. The study was performed in accordance with GLP and to the standardised guideline OECD 422. Only one death was noted during the study. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

Based on the effects noted in the thymus in both male and female rats and in addition in females severe effects on body weight/ body weight gain and food consumption during pregnancy and lactation in the 25 mg/kg diet groups, the NOAEL for parental toxicity was concluded to be the lowest group tested, 5 mg/kg diet which was equivalent to 0.3-0.4 mg/kg bw/day for male animals and 0.3-0.5 mg/kg bw/day for female animals.

A classification for developmental toxicity was not considered necessary because the reproductive effects observed were non-specific and considered to be related to maternal toxicity.

After correction for molecular weight, the NOAEL values from read-across to Dioctyltin oxide were 0.4 -0.5 mg/kg bw/day for male animals and 0.4-0.6 mg/kg bw/day for female animals and the NOEAL for effects on reproductive parameters (mean duration of gestation, post-implantation loss, total number of still born pups) was determined to be 31 mg/kg diet (1.7 mg/kg bw/day).

Justification for classification or non-classification

Reproductive toxicity of diocyltin oxide is limited to clearly parental toxic dose levels. Therefore the reproductive toxicity of dioctyltin oxide is considered an unspecific secondary effect of parental systemic toxicity and thus no classification for reproductive toxicity is required. This data is read-across to Dioctyltin mercaptopropionate based on structural similarity. Target substance and source substances share the identical organotin moiety, and the organotin moiety is generally recognized as the relevant toxophore of organotins. Mercaptopropionic acid is present as mercaptopropionate moiety in the target substance’s molecular structure but is not present in the source substance’s molecular structure. Nevertheless, mercaptopropionic acid is not classified for reproductive toxicity and therefore reproductive toxicity studies with the source substance Dioctylitin oxide are considered to provide adequate and reliable information on the reproductive toxicity of Dioctyltin mercaptopropionate.

According to the criteria of REGULATION (EC) No 1272/2008 and its subsequent adaptions, Dioctyltin mercaptopropionate does not have to be classified and has no obligatory labelling requirement for reproductive toxicity.