Registration Dossier
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EC number: 500-018-3 | CAS number: 9005-64-5 1 - 6.5 moles ethoxylated
Endpoint summary
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
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
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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