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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 May 2012 - 13 Jun 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
2008
Deviations:
yes
Remarks:
the study could have been terminated after 100% mortality in the 300 mg/kg group
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
Deviations:
yes
Remarks:
the study could have been terminated after 100% mortality in the 300 mg/kg group
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Crl: CD(SD)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Approx. 8 weeks
- Weight at study initiation: 161 - 185 g
- Fasting period before study: ca. 16 h
- Housing: in groups of 3 animals in MAKROLON cages on granulated textured wood
- Diet: Commercial diet, ssniff® R/M-H V1534, ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 12-18
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2012-05-21 To: 2012-06-13

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.8% aqueous methylhydroxypropylcellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 5, 30, 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
Doses:
50, 300, 2000 mg/kg bw
No. of animals per sex per dose:
3-6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed
before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after
administration. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study and at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 50 - < 300 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
200 mg/kg bw
Based on:
test mat.
Mortality:
50 mg/kg bw: 0/6
300 mg/kg bw: 3/3 (death within 3 h post dose)
2000 mg/kg bw: 3/3 (death within 3 h post dose)
Clinical signs:
50 mg/kg bw: revealed slightly reduced motility, slight ataxia, slight tremor, slightly reduced muscle tone and slight dyspnoea
300 mg/kg bw: slightly to moderately reduced motility, slight to moderate ataxia, slight to moderate tremor, slightly reduced muscle tone, slight dyspnoea, tonic and clonic convulsions lateral position, lacrimation
2000 mg/kg bw: slightly to severely reduced motility, slight to severe ataxia, slight to moderate tremor, slightly reduced muscle tone, slight dyspnoea, tonic and clonic convulsions
Body weight:
Surviving animals gained body weight
Gross pathology:
no pathological findings

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The LD50 value was ranked between 50 and 300 mg/kg bw. LD50-cut-off value according to OECD TG 423 was 200 mg/kg bw. DMDS should be classified as Acute Tox 3 - H301: Toxic if swallowed.