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Developmental toxicity / teratogenicity

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developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
EC 271-877-7 has no reproductive/developmental toxicity data. However, an OECD 415 one-generation reproductive toxicity has been conducted with Benzenesulfonic acid, C14-C24 branched and linear alkyl derivs. Calcium salts (CAS 115733-09-0). This study resulted in a NOAEL of 500 mg/kg/day (highest dose tested) for reproductive and developmental toxicity. As such, it is unlikely that the EC 271-877-7 will cause reproductive or developmental toxicity.

In addition, an extensive reproductive and developmental toxicity dataset is available for a category of substances known as Linear Alkylbenzene Sulfonates (LAS). LASs were evaluated in a SIDS SIAR (20th SIAM, April, 2005). This category includes alkylbenzene sulfonates with an alkyl length of C10-16. In addition, these are sodium salts. The primary differences between the LASs and EC 271-877-7 are:

- Salt species: The LASs are sodium salts whereas EC 271-877-7 is a calcium salt. The salt species is unlikely to alter the toxicological properties, especially as the salt will likely dissociate after ingestion.
- Alkyl chain length/molecular weight: There is some overlap between the alkyl chain length and molecular weight of the LAS category (C10-C16) and EC 271-877-7 (C15-C18 (C15 rich)). In addition, as EC 271-877-7 has a higher molecular weight, it will be less bioavailable and read across from the LAS category is appropriate.
- Branching of the alkyl chain length: The LAS category is predominantly linear in contrast to EC 271-877-7, which is branched. However, read across is still appropriate as the key functionality (alkaryl sulfonate group) that may be biologically active is conserved.

The SIAR (2005) for LASs has the following data, which adequately covers the data requirements:

Reproductive Toxicity
1. Three-generation reproductive dietary study with C10-14 LAS: no reproductive or developmental toxicity (NOAEL = 350 mg/kg bw/day (highest dose))
2. Three-generation reproductive dietary study with 17% LAS: no reproductive or developmental toxicity (NOAEL = 1000 mg/kg bw/day (highest dose); equivalent to 170 mg/kg bw/day LAS)
3. Four-generation reproductive drinking water study with LAS: no reproductive or developmental toxicity up to 70 mg/kg bw/day, the highest dose tested (NOAEL = 70 mg/kg bw/day).

Developmental Toxicity
In multiple (17 total) oral and dermal studies with LASs in rats, mice and rabbits, no specific developmental toxicity was observed in the absence of confounding maternal toxicity. The conclusion from the SIAR was:

β€œIn 17 developmental toxicity studies, effects such as embryo death or deformities, and litter loss were most often observed only at maternally toxic doses and were associated with the irritation effects of LAS on skin or the gastrointestinal tract. No decreases in litter size, no changes in litter parameters, no malformations or significant differences in skeletal defects were observed at oral doses up to 780 mg/kg bw/day in rats and at dermal doses of 500 mg/kg bw/day in mice and 90 mg/kg bw/day in rabbits.”

Therefore, based on the one-generation study with a calcium alkaryl sulfonate (CAS 115733-09-0) and the robust data set available for LASs, there is sufficient evidence to conclude that EC 271-877-7 is not a reproductive or developmental toxicant and no additional animal studies are warranted.

Data source

Materials and methods

Results and discussion

Results (fetuses)

Fetal abnormalities

not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion