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EC number: 201-126-0 | CAS number: 78-59-1
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
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- Exposure related observations in humans
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- Additional toxicological data

Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- 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: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 965
- Report date:
- 1965
Materials and methods
- Type of study / information:
- Human sensory irritation
- Endpoint addressed:
- respiratory irritation
- Principles of method if other than guideline:
- Experiment was designed to establish the human sensory-irritation threshold of isophorone.
- GLP compliance:
- no
Test material
- Reference substance name:
- 3,5,5-trimethylcyclohex-2-enone
- EC Number:
- 201-126-0
- EC Name:
- 3,5,5-trimethylcyclohex-2-enone
- Cas Number:
- 78-59-1
- Molecular formula:
- C9H14O
- IUPAC Name:
- 3,5,5-trimethylcyclohex-2-enone
- Reference substance name:
- Isophorone
- IUPAC Name:
- Isophorone
- Details on test material:
- Origin: Esso Research and Engineering Company, 21 Dec 1964, used as received
Constituent 1
Constituent 2
Method
- Ethical approval:
- confirmed and informed consent free of coercion received
- Details on study design:
- - Criteria:
1. Detection of odor
2. Nose irritation
3. Eye irritation
4. Throat irritation (instead of skin irritation)
5. Mask removal
- Other information: The test substance did not vaporize immediately, but as there was no deposition on the walls of the aerosol chamber,
complete vaporization was assumed. Nominal concentrations were reported. - Exposure assessment:
- measured
- Details on exposure:
- PERSONS EXPOSED: 6
EXPOSURE
- Reason of exposure: determination of human sensory irritation thresholds
- Type of exposure: gaseous via face mask
- Duration of exposure: 7 minutes per concentration
- Exposure concentrations / dose:
week 1: 100; 199; 377; 513 mg/m3
week 2: 359; 595 mg/m3
Results and discussion
- Results:
- The 7-minute airborne exposure NOAEL for throat and eye irritation in humans are 100 and 199 mg/m3, respectively. The test substance is classified as an irritant to eyes and respiratory system. 100 % odor detection of isophorone was found at 100 mg/m3.
Any other information on results incl. tables
positive observations:
odor detection: 6/6 at 100 mg/m3
nasal irritation: 4/6 at 377 mg/m3; 5/6 at 513 mg/m3
eye irritation: 1/6 at 377 mg/m3; 1/6 at 513 mg/m3
throat irritation: 1/6 at 199 mg/m3; 2/6 at 377 mg/m3
mask removal: 1/6 at 513 mg/m3; 1/6 at 595 mg/m3
second series following week: no significant difference
Conclusion:
Throat irritation < 35 ppm (199 mg/m3)
Eye and nasal irritation < 64 ppm (359 mg/m3)
Applicant's summary and conclusion
- Conclusions:
- In humans irritating effects in eyes, nose and thraot are observed after 7 minutes exposure to concentrations above 100 (= NOAEL, human, throat) and 199 (= NOAEL, human, eyes and nose) mg isophorone/m3.
- Executive summary:
The irritating potential of isophorone was determined in an investigation with 6 volunteers. After exposure to 100, 199, 377 and 513 mg/m3 (week 1) and 359 and 595 mg/m3 (week 2) isophorone for 7 minutes, throat irritation was reported at >= 199 mg/m3, and eye and nasal irritation at concentrations of >= 359 mg/m3. The 7-minute airborne exposure NOAEL for throat and eye irritation in humans are therefore 100 and 199 mg/m3, respectively. The test substance is classified as an irritant to eyes and respiratory system. 100 % odor detection of isophorone was found at 100 mg/m3.
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