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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

No data are available for the registration substance. However adequate and reliable repeated dose toxicity studies performed with a surrogate substance (multi-constituent substance containing high levels of this registration substance) are at hand.

In these subchronic toxicity studies rats were exposed either to aerosol (inhalation exposure) or via oral gavage. In these studies no effects on the macroscopically and microscopically investigated glands and organs related to reproduction were observed. No further studies are available.

Effect on fertility: via oral route
Endpoint conclusion:
no study available
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

No data are available for the registration substance. However an adequate and reliable teratogenicity study performed with a surrogate substance (multi-constituent substance containing high levels of this registration substance) is at hand. In this study the test item was administered to pregnant rats from gestation day 6 - 15. Maternal effects were early deaths as well respiratory rales in all treated groups. In the foetuses no treatment related effects on foetal ossification variations, external, soft tissue or skeletal malformations could be found. With regard to the present study a No Observed Adverse Effect Level (NOAEL) for maternal toxicity could not be established. The respective maternal LOAEL (including effects on reproduction and fertility) in this study is 50 mg test material/kg/day (recalculated to LOAEL = 20 mg/kg/day based on the submission susbtance content in the test material). Based on the lack of any effects concerning the foetal development the developmental NOAEL of this study is 250 mg test material/kg/day (corresponding to 100 mg submission substance/kg/day).

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across: supporting information
Dose descriptor:
LOAEL
Effect level:
20 mg/kg bw/day (actual dose received)
Based on:
test mat.
Remarks:
recalculated to the content of the submission subtance in the test material
Basis for effect level:
clinical signs
mortality
Dose descriptor:
NOAEL
Effect level:
100 mg/kg bw/day (actual dose received)
Based on:
test mat.
Remarks:
recalculated to the content of the submission subtance in the test material
Sex:
male/female
Basis for effect level:
other: developmental toxicity - no treatment -related, biological meaningful effects were observed
Key result
Developmental effects observed:
no
Conclusions:
Oral administration of the test item to the rat at doses of 0, 50, 100 or 250 mg/kg body weight from gestation day 6 - 15 caused early deaths as well respiratory rales in the maternal animals. In the foetuses no treatment related effects on foetal ossification variations, external, soft tissue or skeletal malformations could be found. With regard to the present study a No Observed Adverse Effect Level (NOAEL) for maternal toxicity could not be established. The respective maternal LOAEL (including effects on reproduction and fertility) in this study is 50 mg/kg/day (recalculated to LOAEL = 20 mg/kg/day based on the submission susbtance content in the test material). Based on the lack of any effects concerning the foetal development the developmental NOAEL of this study is 250 mg test material/kg/day (corresponding to 100 mg submission substance/kg/day).
Executive summary:

The study used as source investigated Reaction mass of 7-azatridecane-1,13-diamine and hexamethylenediamine (EC 907 -605 -7, which contains relevant amounts of the submission substance,

7-azatridecane-1,13-diamine).

The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.

Effect on developmental toxicity: 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:
Reliable and adequate study with a surrogate substance of the submission study available (Klimisch 2).
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

Based on the absence of effects on reproductive organs as well as no developmental toxic effects were noted in the above presented studies and based on the criteria in Regulation (EC) No 1272/2008 no classification for reproductive toxicity is proposed.

Additional information