Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
300 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. (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.

 

No reproductive/developmental toxicity was observed at any of the dose levels in an OECD 422 study with Fatty acid reaction product with tetraethylene-pentamine (TEPA), and thus a reproduction/developmental NOAEL of 300 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 diethylene-triamine (AAI-DETA) 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 300 mg/kg/day was established from a combined repeated dose/reproduction toxicity study with Fatty acid reaction product with tetraethylene-pentamine (AAI-TEPA)

Justification for selection of Effect on fertility via oral route:

Most relevant study available.

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

No developmental toxicity was observed in an OECD 422 screening study with Fatty acid reaction product with tetraethylene-pentamine (AAI-TEPA); No developmental toxicity was observed in a developmental toxicity study (OECD 414) study on a similar substance.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 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 developmental toxicity. (See also document in support of category justification).
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 acid reaction product with tetraethylene-pentamine (AAI-TEPA).

Similar OECD 422 studies have been performed on other substances from the group of AAI: on Fatty acid reaction product with diethylene-triamine (AAI-DETA) 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.