Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 11-25, 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: granular
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 2X29911A
- Expiration date of the lot/batch: Oct. 28, 2004

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient temperature

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final dilution of a dissolved solid, stock liquid or gel: 100 mg/mL of test substance in water

FORM AS APPLIED IN THE TEST (if different from that of starting material): solution

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 170-184 g
- Fasting period before study: overnight to 4-5 hrs after exposure
- Housing: up to six animals per macrolon cage
- Diet (e.g. ad libitum): standard lab diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 degrees C
- Humidity (%): Normally 30-70% with incidental limit of 100% due to cleaning/meteorological conditions
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark

IN-LIFE DATES: From: March 11, 2003 To: March 25, 2003

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations - 1 and 4 hrs after dosing, and daily thereafter; bodyweights - Day 0, 3, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, gross pathological changes

Results and discussion

Preliminary study:
Three animals were dosed at 2000 mg/kg. Since none of these animals died, a further three animals were given the same dose.
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died during the study.
Clinical signs:
No clinical signs were noted during the observation period.
Body weight:
All animals gained weight during the study.
Gross pathology:
No treatment related gross pathological findings were observed.

Any other information on results incl. tables

Bodyweights (g)

Animal Number

Day 0

Day 3

Day 7

Day 14

47

175

193

198

212

49

184

204

206

210

51

181

195

204

214

65

170

186

192

216

67

175

196

201

209

69

171

191

200

204

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 for the test substance is > 2000 mg/kg bw. The test substance is therefore considered non-toxic.
Executive summary:

Six animals were exposed to a dose of 2000 mg/kg bw of LMD. None of the animals died during the 14 -day post-exposure observation period. No animals exhibited any adverse effects during the observation period either. The test substance is considered non-toxic.