Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia

Endpoint summary

Description of key information

Oral:
Subchronic Toxicity Study, 90days, oral, rat, OECD 408, up to 1000mg/kg bw/day (AS 50% ): no effects up to highest tested dosage, NOAEL  ≥  1000 mg/kg bw/day (AS 50%), (Henkel, BASF PCN, 1995)
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

500 mg/kg bw/day

Study duration:

subchronic

Species:

rat

Additional information

There are valid sub acute / chronic study data available to assess the repeated dose toxicity of Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia.

Studies according to OECD guidelines:

One subchronic study investigating the oral toxicity of Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia (Henkel, BASF PCN, 1995) is available. The objective of the study was to determine the toxicity and, if possible, a no-effect of the test substance following oral (gavage) administration to the laboratory rats (Hsd/Win:Wu) for 90 days and to evaluate the possible reversibility of any toxic signs following a 29 day treatment-free period (OECD Guideline 408, 1998). Therefore the test substance (AS 50%) was tested for systemic toxicity at repeated doses of 0 (group1), 60 (group 2), 150 (group 3), 300 (group 4) and 1000 (group 5) mg/kg body weight. 10 male and 10 female rats were used for each dose. In addition to the groups 1 and 5, 5 male and 5 female animals were used to determine the reversibility of possible compound-related alterations (recovery group 1 and 5 after a treatment free-period of 29 days).

The test delivered the following results in brief: There were no unscheduled deaths due to the treatment which were considered as substance-related. There were no treatment-related differences in the body weight gain. Both, the food consumption and the food conversion of the different groups were similar. There was a treatment-related increase in the amount of water consumption of the 5 female compared with the control group. There were no differences in the water conversion between the different male and female groups. All values obtained in the hematological studies showed no biological significant differences between the animals of the group 1 and the groups 2 -5. All values obtained in the studies for the clinical chemistry showed no biological significant differences between the animals of the group 1 and the group 2- 5. There were no eye lesions obtained by slit lamp ophthalmology. There were no treatment-related differences in the absolute and relative weights of the organs. There were no treatment-related macroscopical lesions at the necropsy at the end of the treatment or treatment-free period. There were no treatment-related histological lesions at the necropsy at the end of the treatment.

In summary a daily administration of the test substance revealed no systemic or toxic effects in all test groups. Thus, the NOEL-value (NO OBSERVED EFFECT LEVEL) is to determine at 1000mg/kg body weight/day.

As the active substance was only 50% in the test mixture the registrant corrects the NOAEL to 500mg/kg bw/day (AS 100%).

Key study assignment:

As there is only one reliable and relevant study investigating the subchronic effects of Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia this study is integrated as key study.

 

Assessment:

One valid and reliable 90 day subchronic study, administering Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia orally up to 1000 mg/kg bw (AS 50%) is available showing no effects. Therefore the substance is expected to be not toxic without a specific organ toxicity.

Justification for classification or non-classification

As the lowest NOAEL obtained was 500 mg/kg bw/day (AS 100%) 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