Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
1998
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1998

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
acute toxicity: inhalation
Principles of method if other than guideline:
Odor and nasal pungency thresholds were determined in normosmics (2 females and 1 male) and anosmics (2 females and 2 males), respectively exposed to R-(+)-limonene at concentrations of 3.7, 11, 33 and 100%.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Method

Subjects:
- Number of subjects exposed: Seven
- Sex: 4 females, 3 males
- Age: Anosmic group: females: 39-42 years, male: 59 years; Normosmic group: females: 25-37 years, males: 31-58 years
- Known diseases: 3/7 subjects were congenital anosmics i.e. lacking olfaction
Route of exposure:
inhalation
Reason of exposure:
intentional
Exposure assessment:
measured

Results and discussion

Clinical signs:
- Odor threshold for R-(+)-limonene in normosmics was determined to be approximately 10 ppm.
- Nasal pungency was not evoked in the anosmics.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
Odor threshold for R-(+)-limonene in normosmics was determined to be approximately 10 ppm. Nasal pungency was not evoked in the anosmics.
Executive summary:

In an inhalation study, groups of normosmics (2 females and 1 male) and anosmics (2 females and 2 males) were exposed to R-(+)-limonene at concentrations of 3.7, 11, 33 and 100%. Stimuli were presented via 270-mL polypropylene squeeze-bottles containing 30 mL of solution. Odor and nasal pungency thresholds were measured in normosmics and anosmics, respectively via a two-alternative forced-choice procedure with presentation of progressively higher concentrations. Starting from the lowest concentration, each trial entailed the presentation of a blank (mineral oil) and a stimulus. The subject’s task was to choose the stronger stimulus. If the participant was correct, the same concentration was presented next, paired with a blank. If the participant was incorrect, the next higher concentration was presented next, also paired with a blank. The first concentration chosen correctly five times in a row was taken as the threshold. Each type of threshold was measured eight times per subject–stimulus combination. Odor threshold for R-(+)-limonene in normosmics was determined to be approximately 10 ppm. Nasal pungency was not evoked in the anosmics.