Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-11-13 until 2008-11-27
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 402 (Acute Dermal Toxicity)
Version / remarks:
1987, 2008
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Principles of method if other than guideline:
NA
GLP compliance:
yes (incl. certificate)
Test type:
standard acute 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:
male/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
- Weight at study initiation: Male: 217 - 240 g; Female: 200 – 226 g

- Housing: Individual caging (1 animal/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: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.6 - 23.9°C
- Humidity (%): 36 – 60 %
- 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

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The test item was applied in its original form, no formulation was necessitated. The test item was applied in a single dose uniformly at least 10 % area of the total body surface throughout a 24-hour exposure period. Sterile gauze pads were placed on the skin of rats. These gauzes were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then be wrapped with semi-occlusive plastic wrap for 24 hours. At the end of the exposure period, residual test item was removed, using body temperature water or appropriate solvent.
Duration of exposure:
The test item was applied in a single dose uniformly at least 10 % area of the total body surface throughout a 24-hour exposure period.
Animals were observed for a 14-day post-treatment period.
Doses:
The test item was administered in a single dose of 2000 mg/kg bw.
No. of animals per sex per dose:
5 animals/sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The body weight of each animal was recorded on day 0 (beginning of the experiment), on day 7 and on day 14 with a precision of 1 g. A careful individual clinical examination was made on the day of treatment 1 h and 5 h after the administration of the test item, and once each day for 14 days thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (individual observations were performed on the skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern), body weight, gross pathology
Statistics:
NA

Results and discussion

Preliminary study:
No preliminary study.
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Mortality:
No mortality ocurred in male and female rats dermal exposure at a dose level of 2000 mg/kg bw.
Clinical signs:
A single 24-hour dermal exposure at the dose level of 2000 mg/kg bw with the test item SIKA Hardener LI did not induced any test item related adverse effects. The behaviour and physical condition of animals were considered to be normal.
Body weight:
The mean body weight and the body weight gain of the male animals were considered to be normal during the 14-day observation period.
The body weight gain of the animals was considered to be normal with no indication of test item related effects.
Gross pathology:
No test item related macroscopic alterations were found.
Alterations revealed by macroscopic examination were as follows:
• Dilatation and pelvis in kidney
• Diffuse mottled pale areas of the kidney
• Bilateral enlargement of the kidney
• Focal and diffuse dark red discolouration of the lung
• Dark focus in the lung
• Diffuse pale areas in the lung
• Diffuse mottled pale areas of the liver
• Uterus in oestrus
All of the findings listed above were considered to be agonal or incidental changes with no indication of test item related effects.
Other findings:
No other findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, a single 24-hour dermal administration of the test item SIKA Hardener LI caused no mortality and did not induce any test item related adverse effects => LD50 > 2000 mg/kg bw.
Executive summary:

An acute dermal toxicity study (Limit Test), according to OECD 402 Guideline and EU Method B. was performed with SIKA Hardener LI in rats. Five male and five female Wistar rats were treated with SIKA Hardener LI by single administration at a dose level of 2000 mg/kg bw of SIKA Hardener LI in its original form for 24-hour 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, single 24-hour dermal administration of the test item SIKA Hardener LI did not induce any test item related adverse effects.

The acute dermal LD0 and LD50 values of SIKA Hardener LI were 2000 mg/kg bw and greater than 2000 mg/kg bw , respectively, in male and in female Wistar rats.