Registration Dossier
Registration Dossier
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EC number: 209-132-5 | CAS number: 556-61-6
Acute Toxicity: oral
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:
- other: GLP Guidelines Study (OECD 401)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Qualifier:
- according to guideline
- Guideline:
- other: Pesticide assessment guidelines
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Methyl isothiocyanate
- EC Number:
- 209-132-5
- EC Name:
- Methyl isothiocyanate
- Cas Number:
- 556-61-6
- Molecular formula:
- C2H3NS
- IUPAC Name:
- isothiocyanatomethane
- Details on test material:
- Test article name : METHYLSENFOEL (MITC)
Source: DEGUSSA AG
Purity: technical
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm madoerin AG (CH 4414 Fuellinsdorf, Switzerland)
- Age at study initiation: 8-10 weeks old
- Weight at study initiation: males = 181-215g, females = 160-196g
- Fasting period before study: yes, 12/18 hours
- Housing: in Makrolon type-3 cages with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard kliba 343, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2°C
- Humidity (%): 50+/-10%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: polyethylene glycol
- Details on oral exposure:
- Application volume = 10 ml
- Doses:
- 25, 60, 100 and 300 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sexe/dose (after randomization)
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations :4 times during test day 1, and daily during days 2-15.
- Frequency of weighing: test day 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology - Statistics:
- Yes. The LOGIT-model was applied to estimate the LD50 value. Additionally, the 90, 95 and 99% confidence intervals for the LD50 for each sex and the slope of the concentration response line was estimated.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 67 mg/kg bw
- 95% CL:
- > 45 - < 93
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 82 mg/kg bw
- 95% CL:
- > 43 - < 155
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 55 mg/kg bw
- 95% CL:
- > 12 - < 99
- Mortality:
- At 25 mg/kg : 0% of mortality, 60 mg/kg (40%), 100 mg/kg (90%), 300 mg/kg (100%).
- Clinical signs:
- other: -At 25 mg/kg : sedation, dyspnea, curved body position, ruffled fur. -At 60 mg/kg : sedation, dyspnea, curved body position, ruffled fur + spams -At 100 mg/kg : sedation, dyspnea, curved body position, ruffled fur + spams + cryins, ventral body position,
- Gross pathology:
- -At 25 mg/kg (killed animals, 10) : no pathologic changes.
-At 60 mg/kg (dead animals, 4): intestines= reddened, slight.
-At 60 mg/kg (killed animals, 6) : no pathologic changes.
-At 100 mg/kg (dead animals, 9): lung = mottled, intestines = reddened and slight.
-At 100 mg/kg (killed animals, 1): no pathologic changes.
-At 300 mg/kg (dead animals, 10) : lung = mottled and slight. - Other findings:
- no
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category III
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Regulation EC no.1272/2008 (CLP)
- Conclusions:
- In this study, the acute oral LD50 of MITC in rats observed for a period of 14 days is 67 mg/kg.
- Executive summary:
MITC was administered to rats (5 animals/sexe/dose) of both sexes by oral gavage, at 25, 60, 100 and 300 mg/kg bw of MITC. Rats were observed during 14 days after administration. At the lower dose, no mortality was observed. At 60 mg/kg bw, 40% of rats died; 90% at 100 mg/kg bw and 100% at 300 mg/kg bw. Based on observations, the acute oral LD50 of MITC in rats observed for a period of 14 days is 67 mg/kg.
Clinical signs, as sedation, dyspnea, curved body position, ruffled fur were observed at 25 mg/kg bw and higher.
According this result, MITC is classified in the Category 3 on the Regulation EC 1272/2008 as "toxic if swallowed".
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