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Key value for chemical safety assessment

Effects on fertility

Description of key information

Treatment with di C8-C10, branched, C9 rich, alkylnaphthalene sulphonic acid (DNNSA) by oral gavage in male and female Wistar Han rats in a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening at dose levels of 95, 298, and 893 mg/kg body weight/day revealed parental toxicity at 298 and 893 mg/kg body weight/day. No reproduction toxicity was observed for treatment up to 893 mg/kg body weight/day.

Parental NOAEL:          95 mg/kg/day

Reproduction NOAEL:   at least 893 mg/kg/day

Developmental NOAEL: 893 mg/kg/day

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
893 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
guideline study under GLP
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

In a 90 -day study with the calcium salt of the substance no effects on the gonads were found. This is an additional indication that no effects on fertility are expected.

Effects on developmental toxicity

Description of key information

A Combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test ofdi C8-C10, branched, C9 rich, alkylnaphthalene sulphonic acid(DNNSA) was conducted in rats by oral gavage (OECD 422). Developmental toxicity in the form of lower pup body weight in female pups was observed at the high dose of 893 mg/kg on day 4 after birth. There were no significant differences on day 1 in female pups, in male pups on day 1 or day 4 or in combined male and female pup weights on either day 1 or day 4 after birth. No developmental toxicity was observed for the lower treatment groups of 95 and 298 mg/kg body weight/day. Based on the lower female pup weight difference at day 4, the NOAEL was very conservatively set at 298 mg/kg body weight/day. However, clear parental effects were seen at 893 mg/kg bw/d. This included mortality of 4 males and one female and, moreover, some of the clinical signs seen in sacrificed animals were observed in surviving animals. Taken together, the evidence for developmental effects at 893 mg/kg/day is weak or equivocal and very likely secondary to maternal toxicity. As a consequence, for risk assessment purposes the high dose treatment of 893 mg/kg/day is considered the appropriate NOAEL.

Parental NOAEL:          95 mg/kg/day

Reproduction NOAEL:   at least 893 mg/kg/day

Developmental NOAEL: 893 mg/kg/day

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
893 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Guideline study under GLP
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Additional information