Registration Dossier

Administrative data

developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
A waiver for Reaction products of C16 saturated and C18 unsaturated fatty acids and fatty acid glycerides with by-products from 2 aminoethanol and ammonia reaction is based on:

Unreactive: not flammable, explosive, oxidising (see phys-chem),
Insoluble: water solubility 1.4E-5 mg/L
Not inhalable: very viscous
Dermal absorption: very low (logPow > 8.3)
Subacute toxicity: no toxic effects (NOAEL 1000 mg/kg bw)
Appropriateness of a DNEL from a developmental toxicity study: does not change the outcome of the risk assessment, as sensitization is the critical effect
Exposure: limited due to RMM (full body coverage) based on sensitizing properties

Based on the outcome of the risk assessment taking into account the sensitizing properties of the substance, the performance of a developmental toxicity study will not lead to higher protection of the human health.
(i) No significant exposure,
(ii) No concerns about relevance and appropriateness of the DNEL
(iii) Exposures are always well below the derived DNEL for sensitization (and anticipated worst case DNEL based on a developmental toxicity study).

Further explanation anddocumentation is attached

Data source

Materials and methods

Results and discussion

Results (fetuses)

Fetal abnormalities

not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion