Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-11-11 until 2008-11-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is regarded as reliable without restrictions because it was conducted in compliance with GLP regulation and guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
2008
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (Europe) Laboratories Inc.
TOXI COOP Ltd. 1103 Budapest, Cserkesz u. 90.

- Age at study initiation: Young adult rats, 7 weeks old
- Weight at study initiation: 160 – 175 g
- Housing: Group caging (3 animals/cage)
- Diet (e.g. ad libitum): ssniff SM R/M-Z+H, ad libitum
- Water (e.g. ad libitum): tap water from municipal supply, ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2-25.0 °C
- Humidity (%): 34 - 68 %
- Air changes (per hr): 8-12 air exchanges/hour by central air-condition system.
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
A single oral administration - followed by a fourteen days observation period - was performed by gavage. Animals were treated with the test item prepared freshly in the morning hours. A constant treatment volume of 10 mL/kg bodyweight was applied. The concentration was adjusted to ensure constant treating
volumes.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 female animals (nulliparous, non pregnant)
3 animals/step
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed individually continuously during the first 30 minutes, 1 h, 2 h, 3 h, 4 h, 6 h after the treatment and once each day for 14 days thereafter. The body weights were measured and recorded on day -1 and 0 (beginning of the experiment), and on days 7 and 14 with a precision of 1 g.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: gross pathology
Statistics:
NA

Results and discussion

Preliminary study:
No preliminary study.
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
SIKA Hardener LI did not cause mortality at 2000 mg/kg bw.
Clinical signs:
Treatment group 1 – 2000 mg/kg bw
Treating with SIKA Hardener LI at a dose level of 2000 mg/kg bw did not cause any adverse treatment related effects in this dose group.

Treatment group 2 – 2000 mg/kg bw
Treating with SIKA Hardener LI at a dose level of 2000 mg/kg bw did not cause any adverse treatment related effects in this dose group also.
Body weight:
The body weight gain of the animals was considered to be normal with no indication of any test item related effect.
Gross pathology:
2000 mg/kg bw – Treatment group 1
Mottled pale areas in the liver, diffuse dark red discolouration of the lung and collapsed lung with dark red focus was observed in this dose group.

2000 mg/kg bw – Treatment group 2
Uterus in oestrus was recorded in case of one animal in this dose group.

In summary, a single oral gavage treatment with SIKA Hardener LI did not cause any test article related adverse effects, all findings were typical of rats following euthanasia and exsanguination.
Other findings:
No other findings

Any other information on results incl. tables

- The method used is not intended to allow calculation of a precise LD50 value, but an LD50 value is assigned, according to the OECD Guideline No.423 and Comission Regulation (EC) No 440/2008, Annex Part B, B.1.tris: "Acute Oral Toxicity – Acute Toxic Class Method", Official Journal of the European Union No. L 142, dated May 31st, 2008.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Under the conditions of the present study, a single oral administration of the test item SIKA Hardener LI at the dose level of 2000 mg/kg bw did not cause any treatment related adverse effects.
Executive summary:

The acute toxicity oral of SIKA Hardener LI was examined by an acute toxic class method according to the OECD Guideline 423 and the EU method B.1. Two groups of three female Wistar rats were treated with SIKA Hardener LI by a single oral administration by gavage at a dose levels of 2000 mg/kg bw using Polyethylene glycol as a vehicle. The concentration of the formulations in Polyethylene Glycol was 200 mg/mL administered by a constant treatment volume of 10 mL/kg bw. Based on the results of the study and according to the criteria of the relevant test guidelines no further testing was performed.

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. Additionally uterus in oestrus was recorded in one animal.

All of the changes listed below were considered to be agonal or incidental.

Under the conditions of the present study, a single oral administration of the test item SIKA Hardener LI at the dose level of 2000 mg/kg bw did not cause any treatment related adverse effects. Thus, the LD0 value and LD50 values assigned were 2000 mg/kg bw and > 2000 mg/kg bw, respectively.