Registration Dossier

Administrative data

Description of key information

Oral:
Subacute Toxicity Study 28days, oral, rat, OECD 422, up to 1000mg/kg bw/day tested: no adverse effects up to and including highest tested dosage, NOAEL ≥ 1000mg/kg bw/day (BASF SE, 2013, 85R0072/12X119)
Dermal:
No data available
Inhalation:
No data available

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

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are valid sub acute / chronic study data available to assess the repeated dose toxicity of Fatty acids, C18-unsatd., dimers, ethoxylated

Studies according to OECD guidelines:

In a 14 day dose range finder study (BASF SE, 2012, D57190) performed to determine dose levels of the test item suitable for use in a subsequent Reproduction/Developmental Toxicity Screening Test in the Han Wistar Rat, the test item was administered orally by gavage once daily at dose levels of 300 and 1000 mg/kg bw/day. No relevant clinical symptoms or macroscopical findings were noted at any dose level but for males at 1000 mg/kg bw/day, liver weights were increased. No effects on mean food consumption, mean body weight and mean body weight gain were noted at any dose level. Based on these observations, dose levels of 100, 300 and 1000 mg/kg bw/day were considered appropriate for the subsequent Reproduction/Developmental Toxicity Screening Test in the Han Wistar Rat.

In a subsequent valid investigation (BASF SE, 2013, 85R0072/12X119) of the toxicological effects resulting from repeated oral-gavage administration of the test item Fatty acids, C18-unsatd., dimers, ethoxylated to rats according to OECD guideline 422, Fatty acids, C18-unsatd., dimers, ethoxylated was administered in olive oil as vehicle at dosages of 100, 300 and 1000 mg/kg body weight/day, and controls received the vehicle only. Fatty acids, C18-unsatd., dimers, ethoxylated was administered to male rats for 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum.There were no unplanned deaths and no treatment related macroscopical findings. In-life observations of the animals showed decreased rearings in one male at 300 mg/kg bw/day and two males at 1000 mg/kg bw/day, and a slight decrease of body temperature in males and females at 1000 mg/kg bw/day. In the absence of any other changes, these findings were considered to be not adverse. Food consumption and body weights were generally unaffected by treatment. At histopathological examination, minimal centrilobular hepatocellular hypertrophy in the liver of high dose group males was noted that correlated with increased liver weights. This lesion was considered to be of metabolic nature. Furthermore, slight aspiration pneumonia in low dose group animals and slight to moderate aspiration pneumonia in animals from the intermediate and high dose groups could be attributed to treatment, most likely due to accidental uptake by regurgitation of the test item. A slightly higher incidence and/or severity grade of pneumonia was recorded in animals at a dose level of 300 and 1000 mg/kg bw/day, may be explained by an increased viscosity of the test item/vehicle with increasing concentration of the test item. Based on the microscopic findings recorded in the liver, a histopathological NOEL (No Observed Effect Level) was established at 300 mg/kg/day. The NOAEL (No Observed Adverse Effect Level) for systemic toxicity was considered to be 1000 mg/kg bw/day.

In summary a daily administration of the test substance revealed no adverse systemic or toxic effects in all test groups up the highest tested concentration of 1000 mg/kg bw/day.

Key study assignment:

As there is only one reliable and relevant study investigating the subacute effects of Fatty acids, C18-unsatd., dimers, ethoxylated this study is integrated as key study.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Most adequate and reliable result, see discussion.

Justification for classification or non-classification

As the NOAEL obtained was 1000 mg/kg bw/day and no specific target organ toxicity could be observed at this concentration (no higher concentration was tested) a classification according to GHS (Regulation (EU) 1272/2008) as specific target organ toxicity or an additional classification according to DPD (67/548/EEC) as harmful R48 is not indicated or justified.

 

Labelling for specific target organ toxicity or danger at prolonged exposure:

GHS:no additional labelling

DSD: no additional labelling