Registration Dossier

Administrative data

Description of key information

OECD guideline, GLP-compliant study for acute oral toxicity via the oral route was conducted.

No mortality or adverse findings were recorded during the study period. The LD50 was determined to be greater than the highest dose administered (>2000 mg/kg).

No studies were available for acute toxicity via the dermal or inhalation route. Oral exposure was deemed the only relevant route of exposure for this substance within the EU/EEA.

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:
25 Oct - 22 Nov 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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
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
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.
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.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The LD50 was >2000 mg/kg in the acute oral toxicity study and therefore the criteria for classification under the CLP regulation (EC 1272/2008, as amended) was not met.

The substance is not classified for acute toxicity via the oral route.

No data are available to determine classification via dermal or inhalation routes.