Registration Dossier

Administrative data

Description of key information

The registration substance Hostapon SLG is likely of low chronic toxicity based on the read-across approach:

The chronic toxicity of the registration substance Hostapon SLG was evaluated based on the read-across approach using the repeated dose toxicity data for Hostapon SG and sodium N-lauroyl sarcosinate.

-Hostapon SG was investigated for its repeated dose toxicity in rats according to the Guideline OECD 407. The study included recovery animal groups. Animals were treated at doses of 0, 62.5, 250 and 1000 mg/kg/day. No significant treatment related systemic effect was found up to the highest dose level. At dose of 1000 mg/kg/day microscopic changes in the forestach was found. The lesions consisted of acanthosis, parakeratosis, inflammation, ulceration and erosions. After recovery period of 14 days, these changes were completely reversible. Comparable effects were not seen in the animals of low and mid dose groups. NOAEL of 250 mg/kg/day was assigned for the forestomach local effects and NOAEL of 1000 mg/kg/day was assigned for the systemic effects.

-Sodim N-Lauroyl sarcosinate was given to rats  by gavage daily at doses of 0, 30, 100, and 250 mg/kg bw for up to 92 days. Body weight gain decrease and effects on the stomach was found for animals of 100 and 250 mg/kg/day. The NOAEL was 250 mg/kg bw/day.The NOEL was 30 mg/kg/day and the NOAEL 250 mg/kg bw/day.

-Sodium N-lauroyl sarcosinate was investigated in rats for its chronic toxicity and reproduction toxicity in a 2 -year feeding study. The doses levels applied were 0, 0.2, 1 and 2% in the diet. Males and females were housed together so that fertility could be assessed. No effect on the fertility was found. Histopathological changes of stomach tissues were evident at dose levels of 1 and 2% in the diet. No significant systemic effect was found up to the highest dose level.

-Sodium N-lauroyl sarcosinate were applied to weanling rats by feeding at 2% in diet for 6 months. No effect on weight gain, feeding efficiency, general health, or behavior was observed, and no abnormalities of the internal organs were observed.

Likewise, the registration substance Hostapon SLG is likely of low chronic toxicity.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Reliable and robust database:
- One 28-day toxicity study and subchronic/chronic toxicity studies on the structurally related substance. Consistent outcomes in all available studies
- Consistent outcomes when compared to the metabolism considerations

Additional information

Justification for classification or non-classification

The registration substance was assessed by read-across. No significant systemic effect of repeated dose toxicity can be reliably derived. No classification is warranted.