Dodecylbenzenesulphonic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)

Endpoint summary

Key value for chemical safety assessment

Toxic effect type:

dose-dependent

Effects on fertility

Description of key information

In reproductive toxicity study performed according to the reproduction/developmental toxicity screening test [OECD TG 422], DDBSA did not cause any statistically significant differences in the following parameters examined: gestation length, the number of corpora lutea and implantation, delivery index, precoital time, fertility, mating data and in the histopathological examination. The NOAEL was 400 mg/kg bw/day in both sexes (highest dose tested).

In a reproduction screening study (OECD 421), dietary exposure of rats to 1000 mg/kg/day of AMP had no effect on mating performance or conception, but caused marked, dose-related increases in post-implantation loss (embryo resorption).  At 1000 mg/kg bw, all 12 pregnant females showed evidence of complete litter resorption (100% post-implantation loss), while at 300 mg/kg/day, post-implantation loss was 70% (vs. 10% in controls).  Effects associated with, or secondary to the post-implantation loss increase at 300 mg/kg/day included decreased litter size, increased pup body weight, and decreased gestation body weight and body weight gain.  There were no treatment related effects on reproductive performance in the 100 mg/kg/day group.The no-observed effect level (NOEL) for general toxicity in males was 300 mg/kg/day, while the general toxicity NOEL for females could not be determined, based upon the presence of very slight microscopic liver effects.  The NOEL for reproductive effects was considered to be 100 mg/kg/day.

Effect on fertility: via oral route

Endpoint conclusion:

adverse effect observed

Dose descriptor:

NOAEL

100 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

Effects on reproduction as seen in the study on AMP were only observed at maternally toxic doses.

The NOAEL for reproduction is in a worst case set at the NOAEL of the most toxic component of the substance.

Effects on developmental toxicity

Description of key information

In reproductive toxicity study on DDBSA performed according to the reproduction/developmental toxicity screening test [OECD TG 422], the offspring delivered by chemical-treated rats had been observed until day 4 of postpartum. There were no statistically significant differences were seen in the following parameters: the number of live and dead pups, live pups/implantation ratio, dead pups/implantation ratio, pre-implantation loss, post-implantation loss, sex ratio, viability index, number of neonates with external anomalies, and body weights of pups on post-natal day 0 and day 4. There were no treatment-related changes in all parameters of offspring during the parturition and lactation periods and the NOAEL for developmental toxicity was 400 mg/kg bw/day for F1 pubs (highest dose tested).

In a study according to OECD 414, female rats were daily exposed to 1.0%, 5.0%, and 20% of LAS (20, 100, and 400 mg/kg bw DDBSA/day) in their diet during days 0 through 21 of gestation.

Maternal toxicity: the dams treated with 400 mg/kg bw/day and 100 mg/kg bw/day showed inhibition of body weight gain and local skin effects that compromised the integrity of the skin and caused overt toxicity, like inhibition of the body weight gain.

Effect on offspring: there were no findings indicative of effects of LAS on the foetal parameters evaluated (corpora lutea, implantations, viable foetuses or resorptions). No skeletal and visceral abnormalities were seen in any of the dose groups.

Dermal administration of 300 mg/kg/day of AMP produced significant effects at the test site, as evidenced by scabbing (77% affected) and moderate to severe scaling (35% affected).  The dermal finding of slight scaling at 30 and 100 mg/kg/day was not considered adverse, as the observation was transient in nature and relatively low in incidence.  There was no evidence of test article related systemic maternal or developmental toxicity at any dose level tested.  Under the conditions of this study, the NOAEL for maternal toxicity based on dermal effects was 100 mg/kg/day.  The NOEL for developmental toxicity was 300 mg/kg/day, the highest dose level tested.  Analyses of blood samples confirmed systemic exposure to AMP in a dose-responsive manner, although the study was not designed to quantify percent absorption.

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

400 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 adverse effect observed

Dose descriptor:

NOAEL

300 mg/kg bw/day

Study duration:

subacute

Species:

rat

Additional information

No effect on development was reported in any of the studies available.

The NOAEL for developmental toxicity via the dermal route is in a worst case set at the NOAEL of the most toxic component of the substance. For the oral route no data on AMP is available, therefore the NOAEL of DDBSA is chosen as representative for the substance.

Justification for classification or non-classification

Based on the data on the components, the substance does not need to be classified for reproductive or developmental toxicity according to CLP (Regulation EC No 1272/2008).