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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information
Prenatal developmental toxicity (OECD 414), oral, rat: 
NOAEL developmental toxicity: >5000 mg/kg bw/day
NOAEL maternal toxicity: >5000 mg/kg bw/day
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Additional information
Justification for selection of Effect on fertility via oral route:
No study required since no adverse effects on reproductive organs were seen in a chronic and in a prenatal study.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 2), and is thus sufficient to fulfil the standard information requirements set out in Annex VIII-IX, 8.7, of Regulation (EC) No 1907/2006.
Additional information
Justification for selection of Effect on developmental toxicity: via oral route:
There is only one study available.

Toxicity to reproduction: other studies

Additional information

Developmental Toxicity

One study conducted similar to OECD 414 is available addressing prenatal developmental toxicity ofsorbitan monolaurate, ethoxylated (20 EO, Polysorbate 20, CAS 9005-64-5) in Sprague-Dawley rats (NTP 1992). Female animals received the test substance by oral gavage from gestation day (GD) 6 to 15 at doses of 500 and 5000 mg/kg bw/day.

For both dose groups, no litter parameters were affected, including resorptions, foetal death status, fetal body weight and litter size. At external, visceral and skeletal foetal examination, no treatment-related findings were observed in the fetuses of both treatment groups.

No treatment-related mortalities were observed in the dams in any dose group. Regional hair loss was the only clinical sign observed in maternal animals. At 5000 mg/kg bw/day, body weight gain was reduced by 14% between GD 6 to 20 in dams when compared to the vehicle control. In the same dose group, water intake was increased about 14% during GD 6 and 15 when compared to controls. At autopsy, no treatment-related effects on organ weights were observed. In conclusion, for developmental toxicity, the NOAEL was determined to be >5000 mg/kg bw/day. Regarding maternal toxicity, no effects were observed at the 500 mg/kg bw/day dose level. Regional hair loss, reduced body weight gain and increased water intake were the only effects observed at the relatively high dose level of 5000 mg/kg bw/day. These effects may have some toxicological importance but do not indicate significant toxicity and therefore do not justify classification.

Justification for classification or non-classification

The available data on toxicity to reproduction of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

Additional information