Registration Dossier
Registration Dossier
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EC number: 203-161-7 | CAS number: 103-95-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
- Principles of method if other than guideline:
- Rats acutely dermally exposed to test material and observed for 14 d.
- GLP compliance:
- yes
- Remarks:
- no certificate
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 3-p-cumenyl-2-methylpropionaldehyde
- EC Number:
- 203-161-7
- EC Name:
- 3-p-cumenyl-2-methylpropionaldehyde
- Cas Number:
- 103-95-7
- Molecular formula:
- C13H18O
- IUPAC Name:
- 2-methyl-3-[4-(propan-2-yl)phenyl]propanal
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 79-033-02
- Substance type: Clear liquid
- Physical state: Liquid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino TacN(SD)fBR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Farms, Germantown, New York, United States
- Age at study initiation: Young adult
- Weight at study initiation: 194 to 248 g
- Fasting period before study:
- Housing: Singly in wire cages in accordance with standards described in the "Guide for the Care and Use of Laboratory Animals" (DHEW publication No. (NIH) 78-23, revised 1978.
- Diet: Purina chow 5001; no further data.
- Water: Ad libitum
- Acclimation period: Yes (length not specified)
- Other: All animals examined by veterinarian during quarantine to ensure good health.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- On day prior to treatment the backs of the rats were clipped from the scapular region to the hips using clipper blades. The test material was applied evenly over the back using a B-D disposable syringe.
REMOVAL OF TEST SUBSTANCE
- Washing: Wiped with a dry cloth.
- Time after start of exposure: 24 hrs
TEST MATERIAL
- Volume applied: 5.35 mL/kg - Duration of exposure:
- 24 hrs
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 8 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 1 hr, 3 hr, 5 hr, 24 hr, twice daily thereafter except weekends once daily
- Frequency of weighing: Before exposure, 14 d
- Necropsy of survivors performed: Yes - examinations of lungs, heart, liver, spleen, kidney, adrenals, bladder, stomach, intestines, plus gross examination of external carcass (fur, skin and orifices), peritoneal and pleural mucosa, internal mesentry
- Other examinations performed: Clinical observations
Results and discussion
- Preliminary study:
- No mortality observed in the preliminary study using 2 rats/sex/dose exposed for 24 hrs, observed for 72 hrs with doses of 0.05, 0.16, 0.5, 1.6 and 5.0 g/kg bw .
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: All rats lethargic after 1-3 hrs; 2 animals (F-338, F-340) became ataxic but recovered within 2 hrs. Nasal and ocular discharges observed in most animals lasting approx. 24 hrs. See table II of the attached supporting information.
- Gross pathology:
- No signs indicative of toxicity. No visible lesions in any tissue examined.
Applicant's summary and conclusion
- Conclusions:
- The authors found that the acute dermal LD₅₀ to rats of the test material was > 5000 mg/kg bw.
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