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EC number: 825-258-9 | CAS number: 1226892-46-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No reproductive/developmental toxicity was observed at any of the dose levels in an OECD 422 study with Fatty acid reaction product with diethylene-triamine (AAI-DETA), and thus a reproduction/developmental NOAEL of 100 mg/kg/day was determined. Similar OECD 422 studies have been performed on other substances from the group of AAI: on Fatty acid reaction product with tetraethylene-pentamine (AAI-TEPA) and on Fatty acid reaction product with pentaethylene-hexamine (AAI-PEHA). No indication of concern for reproductive or developmental toxicity was observed in these studies up to the highest dose tested. Also an OECD 414 developmental toxicity in rat on a similar substance showed no concern for developmental effects.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Consistent results from all studies within the whole group of Amidoamine/imidazolines (AAI), indicating a no concerns for reproduction toxicity. (See also document in support of category justification).
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The available data available for the group of Amidoamines/imidazolines (AAI) substances indicate that cross-reading between substances in this group is justified. The data shows that for AAI substances based on shorter polyethyleneamines (EA), relatively higher toxicity is observed compared to AAI based on longer EA. The forming of imidazoline itself does not seem to play a significant role. Read-across to Fatty acid reaction product with diethylene-triamine (AAI-DETA) represents worst case for group of Amidoamines/imidazolines (AAI). (See also document in support of category justification).
No reproductive/developmental toxicity was observed at any of the dose levels in an OECD 422 study with Fatty acid reaction product with diethylene-triamine (AAI-DETA), and thus a reproduction/developmental NOAEL of 100 mg/kg/day was determined. Similar OECD 422 studies have been performed on other substances from the group of AAI: on Fatty acid reaction product with tetraethylene-pentamine (AAI-TEPA) and on Fatty acid reaction product with pentaethylene-hexamine (AAI-PEHA). No indication of concern for reproductive or developmental toxicity was observed in these studies up to the highest dose tested. Also an OECD 414 developmental toxicity in rat on a similar substance showed no concern for developmental effects.
All already available data from the group of AAI substances, including 90-day studies in rats and dogs on a similar substance, suggest low toxicity and have shown no adverse effects on reproductive organs. (See also document in support of category justification).
Also the low likelihood of exposure can be considered as its use is limited to industrial and professional users where following its severe corrosive properties will provide for sufficient protection measures to prevent exposure. The likelihood of exposures via inhalation is low considering the high boiling point (> 300 °C) and very low vapour pressure (< 0.00017 mPa at 25°C) and use applications that do not involve the forming of aerosols, particles or droplets of an inhalable size.
In view of low potential of exposures in combination with an overall low level of toxicity, and a total lack of effects observed in reproductive parameters from developmental toxicity and reproduction screening studies within the group of AAI, and no effects on reproductive organs observed in available repeated dose studies, a 2-generation study is not considered necessary.
Short description of key information:
NOAEL for reproduction/developmental of 100 mg/kg/day was
established from a combined repeated dose/reproduction toxicity study
with Fatty acids, C18 unsat, reaction products with diethylenetriamine
(AAI-DETA).
Justification for selection of Effect on fertility via oral route:
Most relevant study available. Read-across to Fatty acid reaction
product with diethylene-triamine (AAI-DETA) represents worst case for
group of Amidoamines/imidazolines (AAI). (See also document in support
of category justification).
Justification for selection of Effect on fertility via inhalation
route:
Likelihood of exposures via inhalation is low considering the high
boiling point (> 300 °C) and very low vapour pressure (< 0.00017 mPa at
25°C). The potential for inhalation is not significant to justify this
study. Furthermore, as the substance is classified as corrosive, such
testing should normally not be conducted.
Justification for selection of Effect on fertility via dermal route:
All substances from the group of Amidoamine/imidazolines (AAI) are
corrosive to the skin and are not expected to easily pass the skin. The
skin is therefore not a preferred route when studying reproductive
toxicity.
Effects on developmental toxicity
Description of key information
The prenatal developmental toxicity study (OECD 414) on AAI-DETA resulted to a maternal NOAEL of 50 mg/kg. The developmental NOAEL was at least 150 mg/kg.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 150 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Recent OECD 414 guideline study of high validity. Consistent results from all studies within the whole group of Amidoamine/imidazolines (AAI), indicating a no concerns for developmental toxicity.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No developmental toxicity was observed in an OECD 422 screening study with Fatty acids, C18 unsat, reaction products with diethylenetriamine (AAI-DETA). Similar OECD 422 studies have been performed on other substances from the group of AAI: on Fatty acid reaction product with tetraethylene-pentamine (AAI-TEPA) and on Fatty acid reaction product with pentaethylene-hexamine (AAI-PEHA). No indication of concern for reproductive or developmental toxicity was observed in these studies up to the highest dose tested. Also an OECD 414 developmental toxicity in rat on a similar substance showed no concern for developmental effects.
The available data available for the group of Amidoamines/imidazolines (AAI) substances indicate that cross-reading between substances in this group is justified. (See document in support of category justification). The data shows that for AAI substances based on shorter polyethyleneamines (EA), relatively higher toxicity is observed compared to AAI based on longer EA. The forming of imidazoline itself does not seem to play a significant role.
To strengthen the data for the group of AAI, a full prenatal developmental toxicity study in rats according to OECD 414 is therefore intended to perform on FA reaction product with DETA
Justification for selection of Effect on developmental
toxicity: via oral route:
Only available guideline study
Justification for selection of Effect on developmental toxicity: via
inhalation route:
Likelihood of exposures via inhalation is low considering the high
boiling point (> 300 °C) and very low vapour pressure (< 0.00017 mPa at
25°C). The potential for inhalation is not significant to justify this
study. Furthermore, as the substance is classified as corrosive, such
testing should normally not be conducted.
Justification for selection of Effect on developmental toxicity: via
dermal route:
All substances from the group of Amidoamine/imidazolines (AAI) are
corrosive to the skin and are not expected to easily pass the skin. The
skin is therefore not a preferred route when studying developmental
toxicity.
Justification for classification or non-classification
The database of relevant studies available for the group of Amidoamine/imidazolines (AAI) include various OECD 422 studies and an OECD 414 study, that all show no concerns regarding reproduction or developmental toxicity. Also all already available data from the group of AAI substances, including a 90-day study in dogs on a similar substance, indicate low toxicity and no adverse effects on reproductive organs. Thus no classification for toxicity to reproduction or toxicity development is required regarding to the regulation EC n°1272/2008.
Lactation: no adequate information.
Additional information
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