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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January to February 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Softenol 3352
- Substance type: product
- Physical state: white powder
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 9 weeks
- Weight at study initiation: 213-243 g females (mean: 235 g), 285-340 g males (mean: 309 g)
- Fasting period before study: overnight (for a maximum of 20 h)
- Housing: group housing of 3 animals per sex per cage in Macrolon cages (type IV, height 15 cm), containing purified sawdust
- Diet (e.g. ad libitum): standard pelleted laboratory animal diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least for 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
Females: From: 24-JAN-01 To: 07-FEB-01
Males: From 26-JAN-01 To: 09-FEB-01

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Remarks:
(specific gravity 1.036)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: w/w
- Amount of vehicle (if gavage): adjustment was made for the specific gravity of the vehicle, no further details mentioned
- Justification for choice of vehicle: the vehicle was selected based on a pretest, no further details mentioned
- Lot/batch no. (if required): no data
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information