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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:
weight of evidence
Study period:
March 24, 2004 - May 10, 2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Substance was tested as dissolved fraction only.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
2001
Deviations:
no
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
ICR
Remarks:
Crl: WI (Han)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Japan SLC, Inc.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 4 weeks
- Fasting period before study: 4 hours fasting prior to the admnistration
- Housing: Five test animals each were housed in a polycarbonate cage and bred in a breeding room.
- Diet: ad libitum
- Water: tap water, ad libitum
- Acclimation period: approximately 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Photoperiod (hrs dark / hrs light): 12 /12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5 w/v% hydroxypropyl methyl cellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100 mg/mL
- Amount of vehicle: 20 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg


Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 females per group
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before administration, and 7 and 14 days after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsies
Statistics:
none

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat. (dissolved fraction)
Remarks:
27% solution
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 540 mg/kg bw
Based on:
act. ingr.
Mortality:
No deaths were found during the observation period.
Clinical signs:
In the sample group, diarrhea was observed in 2 animals approximately 4 hours after administration, which was resolved by Day 1 after administration with no other abnormalities reported subsequently. In the other animals, no abnormalities were found during the observation period.
Neither were abnormalities in the control group found during the observation period.
Body weight:
No differences were found in body weight on Days 7 and 14 after administration when compared to the control group.
Gross pathology:
No abnormalities identified in any of the test animals.

Any other information on results incl. tables

Table-1      Body weight change

Group

Before administration

After administration (day)

7

14

Sample group

26.5±1.4 (5)

28.9±1.3 (5)

31.0±2.1 (5)

Control groups

26.3±1.0 (5)

28.7±0.9 (5)

31.2±0.7 (5)

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The acute oral LD50 of the test substance in female mice is >2000 mg/kg bw. As the test substance was a 27% solution of registration substance, the recalucated acute oral LD50 of the test substance in female mice is > 540 mg/kg bw.
Executive summary:

The acute oral LD50 for the test substance was determined in an OECD Guideline 420 test. Two groups, each of five female mice were successively dosed with 2000 mg/kg of test substance in 0.5 w/v% hydroxypropyl methyl cellulose (HPMC) and the solvent control (0.5 w/v% HPMC). All animals surrvived until the end of the study. The acute oral LD50 of the test substance in female mice is > 2000 mg/kg bw. As the test substance was a 27% solution of registration substance, the recalucated acute oral LD50 of the test substance in female mice is > 540 mg/kg bw.