Registration Dossier
Registration Dossier
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EC number: 700-526-7 | CAS number: 1333488-95-1
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- methyl (2E)-2-cyano-3-(2,2-difluoro-1,3-benzodioxol-4-yl)prop-2-enoate
- EC Number:
- 700-526-7
- Cas Number:
- 1333488-95-1
- Molecular formula:
- C12H7F2NO4
- IUPAC Name:
- methyl (2E)-2-cyano-3-(2,2-difluoro-1,3-benzodioxol-4-yl)prop-2-enoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino rat (Tif: RAI f (SPF) hybrids of RII/1 x RII/2
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young
- Weight at study initiation: 185-203 g
- Housing: group-housed in Macrolon cages type 4 with standardized soft wood bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 09.04.1991 To: 23.04.1991
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: exposure system developed by Batelle Research Centre (Geneva/Switzerland) and built from stainless steel by Ciba-Geigy Engineering department
- Exposure chamber volume: <1 L
- Method of holding animals in test chamber: animals placed in Macrolon animal holders
- Flow rate of air: 2 L/min
- Method of conditioning air: filtered and humidified
- System of generating particulates/aerosols: micronizing jet mill, cyclone-type classifier
- Method of particle size determination: eight-stage cascade impactor
- Treatment of exhaust air: passage through appropriate filter
- Temperature, humidity, oxygen content in air chamber: 21.2-22.5°C, 46-62%, 21%
TEST ATMOSPHERE
- Brief description of analytical method used: samples of test atmosphere collected by passing through appropriate filters, gravimetric determination
- Samples taken from breathing zone: yes
TEST ATMOSPHERE
- MMAD (Mass median aerodynamic diameter): 1.4-1.6 µm
- GSD (Geometric st. dev.): 2.3-2.9 µm
- Particles <7 µm (% w/w): 92-97
- Particles <3 µm (% w/w): 73-81 - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5799 mg/m3 (nominal), 5186 mg/m3 (measured)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observation for mortality and clinical signs: during and after exposure, daily thereafter
- Frequency of weighing: day 0 (prior to dosing), day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: gross examination of organs at necropsy - Statistics:
- Body weights of treated and untreated animals were compared by analysis of variance.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 5 100 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- > 5 100 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 100 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occurred in this study.
- Clinical signs:
- other: Animals of both sexes exposed to the test material experienced the symptoms of piloerection, hunched posture, dyspnea and reduced spontaneous activity. Animals recovered within 8 days.
- Body weight:
- In the males a significant lower body weight gain was observed in the second week after exposure.
- Gross pathology:
- At necropsy in one exposed female animal spotted lungs were detected. No deviations from normal morphology were found in the remaining animals.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU GHS
- Conclusions:
- In this acute inhalation toxicity study in the rat a combined LD50 value of >5100 mg/m3 was found.
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