Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

For reproductive/developmental toxicity, the NOAEL could be set at 1000 mg/kg bw, due to absence of developmental and reproductive effects.

Link to relevant study records
Reference
Endpoint:
reproductive toxicity, other
Remarks:
Combined Repeated Dose Oral Toxicity Study with the Reproduction/Developmental Toxicity Screening Test in Rat
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The target substance Fatty acids, tall-oil, reaction products with maleic anhydride and triethylene-tetramine (TOFA-MA-TETA) and the source substance Fatty acids, tall-oil, reaction products with di-ethylenetriamine (DETA), maleic anhydride, tetraethylenepentamine (TEPA) and triethylenetetramine (TETA) are characterised by the same starting materials: the hydrophobic part from fatty acids and the hydrophilic part from the polyethyleneamines.
The source substance is a mixture of ethyleneamines of different lengths (DETA, TETA and TEPA). The target substance contains only one ethyleneamine: TETA.
The source and the target substance show therefore the same reactive groups and a similar composition with the absence of two original ethyleneamines (DETA and TEPA) as biggest difference. A read-across to the source is therefore justified.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The target substance actually is manufactured from the same starting materials of the source:
Fatty acids, tall-oil and maleic anhydride. TOFA is reacted with maleic anhydride to make a Diels-Alder intermediate which is a tri-acid. This is reacted with the TETA to produce a mixture of amido-amine & oligomeric UVCB constituents. The source substance also contains two other ethyleneamines: di-ethylenetriamine and tetraethylenepentamine.
The source substance has been registered already and no effects were reported on reproductive/ developmental toxicity parameters measured in a toxicity to reproduction study. There were also no effects reported on general toxicity parameters except for the reported macroscopic/microscopic lung changes.
Due to the lack of clear dose-response relationship (solely restricted to histopathological lung changes), the suitable NOAEL (No observed adverse effect level) general toxicity could not be determined. However, for reproductive/ developmental toxicity, the NOAEL could be set at 1000 mg/kg bw. The same conclusion is applied to the target substance.

3. ANALOGUE APPROACH JUSTIFICATION
The target substance is one of the constituent of the UVCB source substance and thus read-across from the bigger compound Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine to TOFA-MA-TETA is common practice and justified.

4. DATA MATRIX
Whereas the source substance is a Fatty acids, tall-oil, reaction products with di-ethylenetriamine (DETA), maleic anhydride, tetraethylenepentamine (TEPA) and triethylenetetramine (TETA), hence using a mixture of DETA, TETA and TEPA as reactant, the target substance uses pure TETA (triethylenetetramine) instead, being a more purified (narrower cut distillation) form of DETA/TETA/TEPA resulting in a name change of the target substance, being Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine (TETA).
Reason / purpose for cross-reference:
read-across source
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
female
Basis for effect level:
clinical signs
Remarks on result:
not determinable due to absence of adverse toxic effects
Remarks:
no systemic toxicity was seen, but only local, non-systemic effects
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Remarks on result:
not determinable due to absence of adverse toxic effects
Reproductive effects observed:
not specified
Conclusions:
Based on the data generated from a combined repeated dose toxicity and reproduction/developmental toxicity screening test according to OECD 422 with fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine, no effects were reported on reproductive/developmental toxicity parameters measured in this study. There were also no effects reported on general toxicity parameters except for the reported macroscopic/microscopic lung changes, observed in parental animals without a dose response relationship. In absence of any adverse effects on reproductive/developmental toxicity, the NOAEL could be set at 1000 mg/kg bw. This resut is also considered representative for fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine, the target substance, as being a major component of the source substance.
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

For reproductive/developmental toxicity, the NOAEL could be set at 1000 mg/kg bw, due to absence of developmental and reproductive effects.

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
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Due to the absence of developmental and reproductive effects in an OECD 422 study, the substance is not subject to classification for reproductive toxicity according to CLP (Regulation EC No 1272/2008).

Additional information