Registration Dossier
Registration Dossier
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EC number: 285-080-7 | CAS number: 85029-55-6
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 3 months
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Tall oil diethylenetriamine imidazoline
- IUPAC Name:
- Tall oil diethylenetriamine imidazoline
- Reference substance name:
- 1H-Imidazole-1-ethanamine, 4,5-dihydro-, 2-nortall-oil alkyl derivs.
- EC Number:
- 270-500-3
- EC Name:
- 1H-Imidazole-1-ethanamine, 4,5-dihydro-, 2-nortall-oil alkyl derivs.
- Cas Number:
- 68442-97-7
Constituent 1
Constituent 2
Results and discussion
Results (fetuses)
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
No developmental toxicity was observed in an OECD 422 screening study with FA reaction products with tetraethylene-pentamine (Amidoamine/Imidazoline). Additional OECD 422 screening studies have been performed on FA reaction products with DETA and FA reaction products with PolyEA, which have also shown no indication for a concern for reproductive or developmental toxicity. Also an OECD 414 developmental toxicity in rat on a similar substance showed no concern for developmental effects.
The available data on the group of Amidoamine/imidazolines (AAI) indicated that for AAI based on shorter ethylene amines (EA) a higher toxicity is observed compared to AAI based on higher EA. The forming of imidazoline itself does not seem to play a significant role. For cross-reading in general FA + DETA therefore represents the worst case. (See also document in support of category justification).
To strengthen the data for the group of Amidoamine/imidazolines, a full prenatal developmental toxicity study in rats according to OECD 414 is therefore proposed to perform on FA reaction products with DETA
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