Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-11-05 to 2009-04-09
Reliability:
1 (reliable without restriction)
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

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
Principles of method if other than guideline:
NA
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Aldimine 2
- Molecular formula (if other than submission substance): C21H41NO4
- Molecular weight (if other than submission substance): 371.55 g/mol
- Physical state: liquid, almost colourless / faint yellow
- Analytical purity: 96.7 %
- Lot/batch No.: ub2.398B/11
- Expiration date of the lot/batch: 04 August 2011
- Stability under test conditions: stable for at least 3 years
- Storage condition of test material: Keep tightly closed. Store at room temperature at 20 ± 5° in a dry place. Keep away from heat and open flame.

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: 172 – 183 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): 21.3-23.8 °C
- Humidity (%): 34 - 59 %
- 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:
unchanged (no vehicle)
Details on oral exposure:
NA
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:
Animals were observed daily for 14 days after dosing.
Statistics:
NA

Results and discussion

Preliminary study:
No preliminary study was conducted
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 LG did not cause mortality at 2000 mg/kg bw.
Clinical signs:
Treatment group 1 – 2000 mg/kg bw
Treating with Sika Hardener LG 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 LG 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
Irregular surface of the liver, mottled pale areas and focal dark red discolouration of the lung and uterus in oestrus was observed in this dose group.

2000 mg/kg bw – Treatment group 2
Dark red focuses on the lung was recorded in this dose group.

In summary, a single oral gavage treatment with Sika Hardener LG 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

No remarks

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 LG at a dose level of 2000 mg/kg bw did not cause any treatment related adverse effects.
Executive summary:

Two groups of three female Wistar rats were treated with Sika Hardener LG by a single oral (gavage) administration at a dose level of 2000 mg/kg bw according to EU B.1 method and OECD guideline no.423. No mortalities were recorded. No clinical signs were observed during the 14 days observation period. The body weight gain of the animals was considered normal, with no indication of test item related effects. The macroscopic examination revealed some minor alterations, such as Irregular surface of the liver, mottled pale areas and focal dark red discolouration of the lung and uterus. However, these changes were considered incidental and 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 (limit dose) did not cause any treatment related adverse effects. Therefore the acute oral LD0 and LD50 values of Sika Hardener LI were determined to be greater than 2000 mg/kg bw. Based on the results of the study and according to the criteria of the relevant test guidelines no further testing was performed.