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Administrative data

Description of key information

LD50 oral > 2000 mg/kg bw. [Kurth 2007]

LD50dermal > 2000 mg/kg bw. [Kurth 2007]

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 2005 to January 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Remarks:
Han: WIST
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: no data
- Weight at study initiation: males (101 - 117 g); females (102 - 110 g)
- Fasting period before study: approximately 18-19 hours
- Housing: one per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: ≥ 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 55 - 58
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:
oral: gavage
Vehicle:
other: 9.0 mg NaCl + 0.85 mg Myrj 53 ad 1 mL water for injection (Ampuwa)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg
- Lot/batch no.: I: N1630A01, II: N1637A01

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: Limit dose
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 21 days
- Frequency of observations and weighing: at least once daily (clinical observation), once weekly (body weight)
- Necropsy of survivors performed: yes
Statistics:
none (limit test)
Key result
Sex:
male/female
Dose descriptor:
LD50 cut-off
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died.
Clinical signs:
No compound-related findings occurred.
Body weight:
A slight increase in body weight gain was noted in female animals on day 8 and 15. This effect was reversible on day 21 of the study. No compound-related effect on body weight gain was observed in male animals.
Gross pathology:
No treatment-related findings were observed.
Executive summary:

The acute oral toxicity of the test substance was low with a LD50 (cut-off value) > 2000 mg/kg bw in rats according to OECD TG 423. A slight increase in body weight gain was noted in female animals on day 8 and 15. This effect was reversible on day 21 of the study. No effect on body weight gain occured in male rats. Administration was tolerated without mortalities, clinical findings and gross pathological findings.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
This study is GLP compliant and is of high quality (Klimisch Score = 1).

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Feb 2006 - Mar 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose:
reference to same study
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Remarks:
Han:WIST
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: no data
- Weight at study initiation: males (238 - 250 g); females (201 - 208 g)
- Fasting period before study: no data
- Housing: one per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: ≥ 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 54 - 58
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Vehicle:
physiological saline
Details on dermal exposure:
TEST SITE
- Area of exposure: 4 x 9 cm
- % coverage: approximately 10% of the body surface area of a rat
- Type of wrap: gauze

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 477-499 mg (male animals), 402-421 mg (female animals)
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.7 mL
- Concentration: 0.9%
- Lot/batch no.: 4342A191
- Purity: no data
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily (clinical signs, mortality) or once weekly (weighing)
- Necropsy of survivors performed: yes
Statistics:
none (limit test)
Key result
Sex:
male/female
Dose descriptor:
LD50 cut-off
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died.
Clinical signs:
One female animal showed a punctiform scab formation on the abdomen on day 3 and 4 of the study. It is considered to be a spontaneous finding.
No compound-related findings were observed in male and female animals.
Body weight:
After administration of the test substance a slight decrease in body weight was observed in all male animals and one female animal on day 7 of the study. This effect was reversible on day 14.
Gross pathology:
No compound-related effects were noted.
Executive summary:

A single dermal administration of the test substance to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, compound-related clinical findings and gross pathological findings. After administration of the test substance a slight decrease in body weight was observed in all male animals and one female animal on day 7 of the study. This effect was reversible on day 14. According to OECD TG 402 the dermal LD50 of the test substance is therefore > 2000 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
This study is GLP compliant and is of high quality (Klimisch Score = 1).

Additional information

Justification for classification or non-classification

Based on the study results a classification according to Regulation (EC) No. 1272/2008 (CLP) is not required.