Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 Aug - 09 Sep 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1987
Deviations:
yes
Remarks:
Testing was conducted in mice (rat is the preferred rodent species), only two doses were used.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
ICR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Japan Inc., Kanagawa, Japan
- Age at study initiation: 5 weeks
- Weight at study initiation: 26 - 31 g (males); 21 - 25 g (females)
- Fasting period before study: 20 h
- Housing: After randomization, ten animals of the same sex and the same dose group were placed in a plastic cage (28 cm x 34 cm, 18 cm in depth) with shavings at the bottom. The cages were exchanged at twice per week.
- Diet: CE-2 type (Clea Japan Inc., Osaka, Japan), ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 1
- Humidity (%): 60 ± 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 or 20 mL/kg bw
Doses:
2500 and 5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at 1/6, 1/2, 1, 2 and 4 hours after administration and daily (at 10 a.m.) for two weeks thereafter. Body weight of each animal was measured at 0-, 7- and 14-day of observation period.
- Necropsy of survivors performed: Yes
- Other examinations performed: Gross pathology, body weight
Statistics:
Mean body weight of treated groups was compared with the negative control by using t-test.
The incidence of gross finding in treated groups was compared with the vehicle control by using Fisher Exact test.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
No effect on body weight was noted.
Gross pathology:
Necropsy revealed no substance-related findings.

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
Conclusions:
CLP: not classified