Registration Dossier

Administrative data

Description of key information

Oral (OECD 401), rat: LD50 > 5000 mg/kg bw

Read-across from structural analogue source substance 7,7,9-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diol-dimethacrylate CAS 72869-86-4

Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw

Read-across from structural analogue source substance 7,7,9-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diol-dimethacrylate CAS 72869-86-4

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Refer to analogue justification provided in IUCLID section 13.
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Source: CAS 72869-86-4, Ullmann, 1984
Interpretation of results:
other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
Executive summary:

The acute oral toxicity of the target substance is estimated based on an adequate and reliable in vivo study of a structural analogue source substance. The determined LD50 value is > 5000 mg/kg bw. As explained in the analogue justification, the differences in molecular structure between the target and the source substance are unlikely to lead to differences in acute toxicity. Therefore, a LD50 value of > 5000 mg/kg bw for the target substance is considered for the hazard assessment and C&L purposes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
The available information on acute oral toxicity comprises an adequate, reliable (Klimisch score 1) and consistent study from a source substance with similar structure and intrinsic properties. Read-across is justified based on common functional groups, breakdown products, and similar physico-chemical and toxicological properties. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, Item 8.5, of Regulation (EC) No. 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Refer to analogue justification provided in IUCLID section 13.
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Remarks:
Source: CAS 72869-86-4, Holalagoudar, 2016
Interpretation of results:
other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
Executive summary:

The acute dermal toxicity of the target substance is estimated based on an adequate and reliable in vivo study of a structural analogue source substance. In a limit test a LD50 value of > 2000 mg/kg bw has been determined. As explained in the analogue justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in acute toxicity. Therefore, a LD50 value of > 2000 mg/kg bw for the target substance is considered for the hazard assessment and C&L purposes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The available information on acute dermal toxicity comprises an adequate, reliable (Klimisch score 1) and consistent study from a source substance with similar structure and intrinsic properties. Read-across is justified based on common functional groups, breakdown products, and similar physico-chemical and toxicological properties. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII, Item 8.5, of Regulation (EC) No. 1907/2006.

Additional information

Acute toxicity: oral

There is no data on acute oral toxicity available for reaction product of 2,2'-oxydiethanol and 2-hydroxyethyl acrylate and 2-hydroxyethyl methacrylate and hexan-6-olide and trimethylhexa-1,6-diyl diisocyanate (EC 944-336-4). Thus, a read-across approach was performed using the structurally similar substance reaction mass of 7,7,9-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diylbismethacrylate and 7,9,9-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diylbismethacrylate (CAS 72869-86-4). The acute oral toxicity of the source substance was assessed in a study conducted according to OECD guideline 401 and under GLP conditions (Ullmann, 1984). Five KFM-Han Wistar rats/sex were administered 5000 mg/kg bw test substance in 2% carboxymethylcellulose via gavage. There was no mortality during the 14-day study period. 5/5 males and 5/5 females exhibited dyspnea on Day 1 until 5 h after dosing. Ruffled fur was observed in 5/5 males and 5/5 females 1 - 2 h after administration, and a curved body position was observed in 5/5 males and 5/5 females 1 - 3 h after dosing on Day 1. The body weight gain was within the range that is normal for this strain and study type. No findings were reported during the macroscopic examination. The acute oral LD50 value is considered to be > 5000 mg/kg/bw.

 

Acute toxicity: dermal

There is no data on acute dermal toxicity available for reaction product of 2,2'-oxydiethanol and 2-hydroxyethyl acrylate and 2-hydroxyethyl methacrylate and hexan-6-olide and trimethylhexa-1,6-diyl diisocyanate (EC 944-336-4). Thus, a read-across approach was performed using the structurally similar substance reaction mass of 7,7,9-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diylbismethacrylate and 7,9,9-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diylbismethacrylate. The acute dermal toxicity of the source substance was assessed in a study conducted according to OECD guideline 402 and under GLP conditions (Holalagoudar, 2016). Five male and five female Wistar Crl: WI(Han) rats were treated with the test substance by a single semi-occlusive dermal application at 2000 mg/kg bw. The animals were observed for 14 days and body weights were measured. All animals were subjected to a necropsy and a macroscopic examination. No mortality occurred and no clinical signs or signs of local irritation were observed. There were no treatment related effects on body weight or body weight gain. There was no evidence of any observations at a dose level of 2000 mg/kg bw at necropsy. Thus, under the conditions of this study, the acute dermal LD50 value of the test substance was found to be > 2000 mg/kg bw in male and female Crl: WI(Han) rats.

 

Conclusion:

The available data on the acute oral and acute dermal toxicity of reaction mass of 7,7,9-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diylbismethacrylate and 7,9,9-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diylbismethacrylate indicate no effects of acute toxicity. As explained in the analogue justification, the differences in molecular structure between the target and the source substance are unlikely to lead to differences in acute toxicity. Therefore, it can be concluded that the target substance reaction product of 2,2'-oxydiethanol and 2-hydroxyethyl acrylate and 2-hydroxyethyl methacrylate and hexan-6-olide and trimethylhexa-1,6-diyl diisocyanat does as well not cause any effects of acute oral or dermal toxicity.

Justification for classification or non-classification

Based on read-across from a structurally similar substance, the available data on oral and dermal acute toxicity do not meet the classification criteria according to Regulation (EC) No. 1272/2008 (CLP), and are therefore conclusive but not sufficient for classification.