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Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on fertility: via inhalation route
Endpoint conclusion:
no adverse effect observed
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Since no data exist on the reproduction toxicity of LAS IPA, information on LAS Na and IPA were used to assess the reprotoxic potential of the substance.

IPA:

No reproduction toxicity is available with IPA; however, one inhalation pre-natal developmental toxicity OECD 414 study (Kier & Thake, 1988). No effects were observed on reproduction parameters. The NOAELs set in the studiy were only based on systemic toxicity (maternal toxicity) and hence, they are not relevant for this endpoint. No NOAEL for reproductive effects is set.

LAS Na:

LAS Na (C10 -14; CAS 69669 -44 -9) was fed for 84 days to 4 groups of weanling rats for two years (three generations) at doses of 14, 70, 350 mg/kg bw/day. No significant effects were observed even at the highest dose tested and the resulting NOAEL for the parental and both offspring generations was determined to be 350 mg/kg bw/day (0.5%) (Buehler et al., 1971).


Short description of key information:
No studies are available on the reproduction toxicity of LAS IPA. The endpoint was addressed with information from LAS Na and IPA. One three generation study with LAS Na after oral exposure, shows no effects on the reproduction parameters. No OECD 421/422 is available for IPA, since a developmental toxicity (OECD 414) is available. This inhalation study shows no exerted effects on reproduction/fertility.

Justification for selection of Effect on fertility via oral route:
One study was performed with LAS Na addressing the reproduction toxicity of the substance after oral exposure. No effects were observed on reproduction parameters, including fertility, gestation, parturition, neonatal viability, and lactation. The NOAELs set in the study were only based on systemic toxicity and hence, they are not relevant for this endpoint. No NOAEL for reproductive effects is set.

Effects on developmental toxicity

Description of key information
Two studies were performed with LAS Na addressing the developmental toxicity potential of the substance after oral exposure. In these studies marginal teratogenic effects were seen at doses of maternal toxicity. The effect was not considered to be a clear-cut developmental effect and it was associated with maternal toxicity.One inhalation teratology study is available with vapours of isopropylamine. No effects were observed on the development of the foetus/offspring (pre- or post-natally) and the NOAELs set in the study were only based on systemic maternal toxicity; hence, they are not relevant for this endpoint. No NOAEL for developmental effects is set.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no adverse effect observed
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

No data exist on the developmental toxicity of LAS IPA, therefore, information on LAS Na and IPA were used to address this requirement.

IPA:

In a GLP, similar to Guidelines study (Kier & Thake, 1988) female rats were exposed to IPA vapours, whole body, during gestation, at concentrations of 50, 499 or 1000 mg IPA/m3. The substance did not induce embryotoxic, fetotoxic or teratogenic effects, although slight maternal toxicity was observed at the 499 mg/m3 exposure level and substantial maternal toxicity was observed at 1000 mg/m3.

LAS Na:

Pregnant female mice were exposed to LAS via gavage on days 6 -15 of gestation. Increased mortality was observed at the two highest doses (300 and 600 mg/kg bw/day). These doses also exhibited retarded weight gain and adverse signs in the necropsy. Pregnancy was comparable, however, for all groups. At doses without maternal toxicity, no differences were observed in any parameters. Because of the very wide range between the 2 mg/kg and 300 mg/kg doses, the maternal NOAEL of 2 mg/kg bw/day must be considered very conservative. The NOAEL for teratogenicity was 300 mg/kg bw/day (Palmer et al., 1971)

Pregnant female rats were given LAS orally in distilled water from gestation days 6 to 15 at doses of 0.2, 2, 300, 600 mg/kg bw/day. Some effects such as decreased weight gain and transient diarrhea occurred at the highest dose. Pregnancy rates were comparable at all doses. Litter parameters were not significantly affected at any dose. No significant differences were observed in visceral anomalies or skeletal variants, with the exception of a marginal retardation of sternabral ossification at the highest dose. The NOAEL was set at 300 mg/kg bw/day both for maternal toxicity and teratogenicity (Palmer et al., 1975).

Based on the results of the aforementioned studies LAS IPA is not considered to be a developmental toxicant.


Justification for selection of Effect on developmental toxicity: via oral route:
Only studies with LAS Na are available via the oral route. In these studies marginal teratogenic effects were seen at doses of maternal toxicity. The effect was not considered to be a clear-cut developmental effect and it was associated with maternal toxicity. No NOAEL for developmental effects is set.

Justification for selection of Effect on developmental toxicity: via inhalation route:
One inhalation study is available with vapours of isopropylamine. No effects were observed on the development of the foetus/offspring (pre- or post-natally) and the NOAELs set in the study were only based on systemic maternal toxicity; hence, they are not relevant for this endpoint. No NOAEL for developmental effects is set.

Justification for classification or non-classification

Based on the available data, for LAS Na and IPA, LAS IPA does not need to be classified for effects on fertility and developmental toxicity according to Regulation (EC) No. 1272/2008.

Additional information