3,5,5-trimethylcyclohex-2-enone

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:

1965

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

Test material information

Constituent 1

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

Constituent 2

Reference substance name:

Isophorone

IUPAC Name:

Isophorone

Details on test material:

Origin: Esso Research and Engineering Company, 21 Dec 1964, used as received

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.