Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 Oct - 22 Nov 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
other: MHW guideline (Yakushin No. 118, 1984)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Japan, Inc, Japan
- Age at study initiation: 5 weeks
- Weight at study initiation: 127 - 130 g (males); 97 - 109 g (females)
- Fasting period before study: yes, overnight
- Housing: 5 rats per cage were housed in polycarbonate cages (265W x 426D x 200Hmm, Tokiwa Kagaku Kikai Co., Ltd.) with bedding (Beta chip, Charles River Japan, Inc.) for laboratory animals . The cages were stored in rat cage rack of 4 rows (Tokiwa Kagaku Kikai Co., Ltd.). The cages (including bedding), stainless feeder for pellet food (Tokiwa Kagaku Kikai Co., Ltd.) and polycarbonate water-dispensing bottle (500 mL: Tokiwa Kagaku Kikai Co., Ltd.) were changed every week with autoclaved ones.
- Diet: pellet food for laboratory animals (MF, Oriental Yeast Co., Ltd.), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): about 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 08 Nov 1988 To: 22 Nov 1988

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Amount of vehicle: 10 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for signs of toxicity 30 min, 1, 3 and 6 h after administration and thereafter once daily up to the end of the observation period. Body weights were recorded prior to administration, and on Days 3, 7 and 14.
- Necropsy of survivors performed: Yes, all animals were sacrificed by excessive bleeding from the vetral aorta under anesthesia with sodium pentobarbital.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
A gait anomaly was seen in 1/5 males 30 min after the test substance administration, which diminished within 3 hours after the administration.
Body weight:
No effect on body weight was noted.
Gross pathology:
A red spot was seen in the lung of 1/5 males. The change was considered to be incidentally, since the change was minimal and not observed in the treated females.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008