Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: granular
Details on test material:
-Appearance: colorless to pale yellow
-Molecular weight: 136.15
-Melting point: 111.7 °C
-Boiling point: 263 °C
- soluble in organic solvents, almost insoluble in vegetable oils, sparingly water soluble
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: sealed at a cool (4 °C) and dark place
- Stability under test conditions: stable during use period
- Solubility and stability of the test substance in the solvent/vehicle: uniform administration solution in 1 % methylcellulose in water


TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: dissolved in 1 % methylcellulose in water

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Remarks:
SPF
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 5 weeks
- Weight at study initiation:
males:
mean body weight at time of administration: 134 g (range: 127 - 138 g)
females:
mean body weight at time of administration: 116 g (range: 110 - 120 g)
- Fasting period before study: approximately 12.5 hours
- Housing: in stainless steel wire mesh cages, separated by sex
acclimation period: three rats were co-housed,
after administration: two to three rats were co-housed
- Diet ad libitum: obtained from Nosan Kako Co., Ltd., Japan, national type feed laboratory MR stock, Lot No. 97.12.61 (assumed)
- Water ad libitum: sterile tap water irradiated with ultraviolet rays
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22 °C
- Humidity (%): 52 - 59 %
- Air changes (per hr): 10 times or more per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
methylcellulose
Remarks:
1 % in aqueous solution
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1 mL/kg bw
Doses:
0, 1000 and 2000 mg/kg
No. of animals per sex per dose:
5 males/ 5 females
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observations were carried out 1, 3 and 6 hours after administration and daily thereafter until day 14.
Weighing was carried out shortly before administration and on days 1,3,7 and 14 after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights
Statistics:
The LD50 could not be calculated because no lethality occurred.

Results and discussion

Preliminary study:
3 males and 3 females per group were exposed to doses of 1000, 2000 and 4000 mg/ kg bw. One male of the 4000 mg/ kg bw dose group displayed weak acute toxicity.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality observed
Clinical signs:
no effects observed
Body weight:
no effects observed
Gross pathology:
no effects observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 (male and females rats) > 2000 mg/kg bw
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.