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Administrative data

Description of key information

In a acute oral toxicity with the test item according to OECD guideline 438 an an oral discriminating dose of 2000 mg/kgbw of Sika Hardener LTJ was estimated.

 

One additional read across study is available with the hydrolysis product of the test item Aldehyd L. The LD 50 was determined to be >2000 mg/kg bw.

 

 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Only one GLP and guideline supporting study for 2,2-Dimethyl-3-lauroyloxy-propanal available.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

 

For the target substance (SIKA Hardener LTJ, CAS 613246-79-0) data on acute oral toxicity is available. Because the substance itself decomposes rapidly during use a further read across study with the hydrolysis product Aldehyd L (products 2,2-Dimethyl-3-lauroyloxypropanal, CAS No. 102985-93-3) was filled in.

 

LTJ is a reaction mixture (different oligomeres) of the two substances 2,2-Dimethyl-3-lauroyloxypropanal (CAS No. 102985-93-3) and Polyetheramin T 403 (CAS No. 39423-51-3). During use of the substance as hardener it hydrolysis into the mentioned degradation products 2,2-Dimethyl-3-lauroyloxypropanal (CAS No. 102985-93-3) and Polyetheramin T 403 (CAS No. 39423-51-3).

 

Oral

A study was conducted according to OECD TG 423 and according to Directive 2004/73/EC method B.1.tris acute oral toxicity - acute toxic class method. The single-dose oral toxicity of the test item was evaluated in Wistar rats. Two groups of 3 female animals were received a single oral administration of the test item. The dose level was 2000 mg/kg bw. A gross necropsy examination was performed on all study animals at the time of death or scheduled euthanasia (day 14). No mortality occured and all animals were symptom-free on the day of treatment and during the 14-day observation period. The body weight development of each animal treated with the test item was normal during the two weeks observation period, similar to untreated female animals of the same age and strain. No macroscopic alterations related to the toxic effect of the test item were found. Under the conditions of the present study, a single oral administration of the test item Sika Hardener LTJ (VP) caused no toxic effects at 2000 mg/kg bw. In the female rat, a oral discriminating does of 2000 mg/kg bw was estimated.

 

In a supporting study with the hydrolysis prodct of the test item a toxic class method according to OECD 423 was performed with 2,2-Dimethyl-3-lauroyloxy-propanal was conducted. Six female CRL:(WI) BR Wistar rats were treated with 2,2-Dimethyl-3-lauroyloxy-propanal by oral gavage (single application) at a dose level of 2000 mg/kg in sunflower oil. There was no mortality in the study. Based on these findings no further testing was performed. No clinical signs appeared after administration of 2,2-Dimethyl-3-lauroyloxy-propanal at 2000 mg/kg dose level. No effects on mean body weight and body weight gain were noted for these dose groups. Macroscopic alterations due to the toxic effect of the test item 2,2-Dimethyl-3-lauroyloxy-propanal were not found. Based on the results of this test. The acute oral LD50 of 2,2-Dimethyl-3-lauroyloxy-propanal was estimated to be greater than 2000 mg/kg bw in the rat.

Justification for classification or non-classification

Based on the results obtained from testing the test item was not classified and labelled with regard to acute oral toxicity according to Regulation (EC) No 1272/2008 (CLP).