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EC number: 209-132-5 | CAS number: 556-61-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 402)
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 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: EPA - Pesticide assessment guidelines.
- 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
Solid; above 35 degrees centigrade liquid.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG (CH4414 Fuellinsdorf/ Switzerland)
- Age at study initiation: 15-16 weeks old
- Weight at study initiation: males = 1.8/3.2 kg, females = 2.6-3.4 kg
- Fasting period before study: no data
- Housing: individually in stainless steel cages equipped with an automatic cleaning and drinking system.
- Diet (e.g. ad libitum): pelleted standard kliba 341, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 55+/-10
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 (music/light period)
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: backs of the animals
- % coverage: 40 square centimeters
- Type of wrap if used: after application, area was covered with an occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml (50 mg/kg), 0.15 ml (150 mg/kg), 0.30 ml (300 mg/kg) - Duration of exposure:
- 24 hours
- Doses:
- 50, 150 and 300 mg/kg bw
- No. of animals per sex per dose:
- 5 rabbits/ sexe/ dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations: four 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:
- 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
- Preliminary study:
- no
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 174 mg/kg bw
- 95% CL:
- > 123 - < 272
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 145 mg/kg bw
- 95% CL:
- > 81 - < 293
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 202 mg/kg bw
- 95% CL:
- > 106 - < 140
- Mortality:
- At 50 mg/kg : 0% of mortality. At 150 mg/kg = 30%, and at 300 mg/kg : 90 % of mortality.
- Clinical signs:
- other: -At 50 mg/kg : sedation, dyspnea, myosis, erythema, edema, necrosis, curved body position. -At 150 mg/kg : sedation, dyspnea, myosis, erythema, edema, necrosis + atawia (males), latero-abdominal position (males), salivation -At 300 mg/kg : sedation, dyspn
- Gross pathology:
- -At 50 mg/kg (killed animals, 10) : lung (mottled, slight) = 1, no pathologic changes = 9.
-At 150 mg/kg (dead animals, 3) : lung (mottled, slight) =1, liver (mottled, slight) =1, no pathologic changes =1.
-At 150 mg/kg (killed animals, 7) : lung (mottled, severe) = 3, dark-red = 2, no pathologic changes =4.
-At 300 mg/kg (dead animals,9) : lung (mottled, slight) =1, lung (mottled, severe) = 1, dark-red seveve = 4, liver pale = 4, mottled = 2; stomach (marginal area, spotted, dark-red)=1, mammary glands (discolored, dark-red) =1, no pathologic changes =1.
-At 300 mg/kg (killed animals, 1) : lung (mottled, slight) = 1. - Other findings:
- no
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category II
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Guidance on the application of regulation(EC) No 1272/2008
- Conclusions:
- Based on the observations, the LOGIT-Estimation for the acute dermal LD50 of MITC in rabbits of both sexes over a period of 15 days is 174 mg/kg.
- Executive summary:
MITC was applied to the skin of rabbits (5/dose/sex) of both sexes for 24 hours at 50, 150 and 300 mg/kg bw.
Animals were observed during 15 days, mortality, clinical signs and bodyweight were recorded.
No mortality were observed at 50 mg/kg bw. 30% of rabbits died at 150 mg/kg bw, and 90% at 300 mg/kg bw.
Clinical signs as sedation, dyspnea, miosis, erythema, edema, necrosis, curved body position were observed at 50 mg/kg bw and higher.
Based on the observations, the acute dermal LD50 of MITC in rabbits of both sexes over a period of 15 days is 174 mg/kg.
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