Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 January - 31 January, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Conducted prior to GLP, and the availabilty of OECD guidelines. No information on the purity of the test sample, limited information on the animals and the conditions of the testing (such as no information on temperature and humidity) but adequate for the purposes of hazard classification

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): BUSAN 11-1M
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: 47601
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
- Other: No data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sprague Dawley, Madison, WI
- Age at study initiation: No data
- Weight at study initiation: 221 - 261 g (males) 208 - 215 g (females)
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: 26 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: 19/12/1978 To: 31/1/1979

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
VEHICLE
- Concentration in vehicle: No data
- Amount of vehicle (if gavage): No data
- Justification for choice of vehicle: No data
- Lot/batch no. (if required): No data
- Purity: No data

MAXIMUM DOSE VOLUME APPLIED: No data

DOSAGE PREPARATION (if unusual): No data
Doses:
0.34, 0.50, 0.73, 1.07, 2.31, 5.0 g/kg
No. of animals per sex per dose:
8 rats/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Weight was measured at study initiation, day 7 and study termination
Pharmacotoxic signs were observed at hours 1, 2, 5 and daily thereafter.
- Necropsy of survivors performed: yes
Statistics:
No further data

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
850 mg/kg bw
Based on:
test mat.
95% CL:
700 - 1 130
Sex:
female
Dose descriptor:
LD50
Effect level:
530 mg/kg bw
Based on:
test mat.
95% CL:
380 - 660
Mortality:
No animals died in the 0.34 dosage group
1 male and 6 females died in the 0.5 dosage group
3 males and 6 females died in the 0.73 dosage group
6 males and all females died in the 1.07 dosage group
All animals died in the 2.31 dosage group
All animals died in the 5.0 dosage group
Clinical signs:
0.34 dosage group: all animals appeared normal with no clinical signs
0.5 dosage group - 5.0 dosage group: Animals showed a range of symptoms including diarrhea, hypoactivity, ataxia, decrease limb tone, bradypnea, piloerection, absence of grasping reflex, hypothermic to touch, fasciculations, prostration, bradycardia, loss of pain reflex, loss of placing reflex, flaccidity
Body weight:
0.34 dosage group: average male body weight was 304 day 7 and 334 at termination, while average female body weight was 246 day 7 and 253 at termination
0.5 dosage group: average male body weight was 263 day 7 and 297 at termination, while average female body weight was 255 day 7 and 268 at termination
0.73 dosage group: average male body weight was 321 day 7 and 343 at termination, while average female body weight was 244 day 7 and 245 at termination
1.07 dosage group: average male body weight was 313 day 7 and 348 at termination, while all females died prior to reaching the day 7 weighing point
2.31 dosage group: All animals died prior to reaching the day 7 weighing point
5.0 dosage group: All animals died prior to reaching the day 7 weighing point
Gross pathology:
No significant visible lesions were observed
Other findings:
No further data

Any other information on results incl. tables

No further data

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 was found to be 0.85 g/kg in males and 0.53 g/kg in females. Therefore it is classified as Category 4, signal word warning, hazard statement H302: Harmful if swallowed.
Executive summary:

The test substance Busan 11-M1 was administered to 8 rats/sex/dose male and female Sprague-Dawley rats in dosages administered at 0.34, 0.50, 0.73, 1.07, 2.31, 5.0 g/kg. The test animals were observed for 14 days following administration. Under the conditions of this study, the oral LD50 of the test substance was determined to be 0.85 g/kg in males and 0.53 g/kg in females . Based on this result, Busan 11-M1 is classified as Category 4, signal word warning, hazard statement H302: Harmful if swallowed in accordance with Regulation EC No. 1272/2008.