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Administrative data

Description of key information

SIKA Hardener LI was tested in an acute oral toxicity study according to EU method B.1tris and OECD guideline 423. No treatment related effects were observed up to dose levels of 2000 mg/kg bw. The LD50-value was greater 2000 mg/kg bw and the NOEL 2000 mg/kg bw. SIKA Hardener LI was tested in an acute dermal toxicity study according to EU method B.3 and OECD guideline 402. No treatment related effects were observed up to dose levels of 2000 mg/kg bw. The LD50-value was greater 2000 mg/kg bw and the NOEL 2000 mg/kg bw. Testing via the inhalation route was waived, according to REACH Regulation (EC) No 1907/2006, Annex VIII, 8.5.2.

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:
GLP and Guideline study

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
GLP and Guideline study

Additional information

Acute toxicity oral

The acute toxicity oral of SIKA Hardener LI was tested according to EU method B.1tris and OECD guideline 423 (limit test). Two groups of three female Wistar rats were treated with SIKA Hardener LI by a single oral (gavage) administration at a dose level of 2000 mg/kg bw using Polyethylene glycol as a vehicle. The concentration of Polyethylene Glycol in formulations was 200 mg/mL administered by a constant treatment volume of 10 mL/kg bw. No mortalities were recorded. No clinical signs were observed under the duration of the 14 days observation period. The body weight gain of the animals was considered to be normal with no indication of test item related effect. The macroscopic examination revealed some minor alterations as mottled pale areas in the liver, diffuse dark red discolouration of the lung, dark focus on the lung and collapsed lung. As these changes were considered to be agonal or incidental it was concluded that under the conditions of the present study, a single oral administration of the test item SIKA Hardener LI, at a dose level of 2000 mg/kg bw did not cause any treatment related adverse effects. Therefore the acute oral LD0 and LD50 values of SIKA Hardener LI were determined 2000 mg/kg bw and greater than 2000 mg/kg bw .

 

Acute toxicity dermal

SIKA Hardener LI was tested in an acute dermal toxicity study according to EU method B.3 and OECD guideline 402 (limit test). Five male and five female Wistar rats were treated with a single administration at a dose level of 2000 mg/kg bw in its original form for 24 h in a semi-occlusive manner. No mortalities occurred, neither in male nor in female rats during the 14 days observation period. Behaviour and general state of animals were considered to be normal. All pathological findings were considered incidental changes with no indication of test item related effects. Thus, under the conditions of this study, SIKA Hardener LI did not induce any test item related adverse effects. The acute dermal LD0 and LD50 -values of SIKA Hardener LI were considered to be 2000 mg/kg bw and greater than 2000 mg/kg bw, respectively.

 

Acute toxicity inhalation

Additional testing by inhalation route is not applicable as an acute oral toxicity study and an acute dermal toxicity study were performed. According to the REACH Regulation No. 1907/2006, Annex VIII, 8.5 only two acute dose toxicity studies are required, with test item administration via the most appropriate route.


Justification for selection of acute toxicity – oral endpoint
only one study available

Justification for selection of acute toxicity – dermal endpoint
only one study available

Justification for classification or non-classification

Based on results obtained in acute toxicity studies SIKA Hardener LI was not classified and labelled according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).