Essential Oil of Piper nigrum L. (Family: Piperaceae). Obtained by the steam distillation of dried unripe berries.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from authoritive database

Data source

Reference

Reference Type:

publication

Title:

Hazardous Substances Data Bank (HSDB) for linalol

Author:

U.S National Library of Medicine

Year:

2017

Bibliographic source:

Hazardous Substances Data Bank (HSDB) for linalool U.S National Library of Medicine 2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To evaluate eye irritation potential of (3S)-3,7-dimethylocta-1,6-dien-3-ol on New Zealand white rabbits

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Linalool

EC Number:

201-134-4

EC Name:

Linalool

Cas Number:

78-70-6

Molecular formula:

C10H18O

IUPAC Name:

(3S)-3,7-dimethylocta-1,6-dien-3-ol

Test material form:

liquid

Details on test material:

IUPAC name:(3S)-3,7-dimethylocta-1,6-dien-3-ol
commen name: Linalool
Molecular formula :C10H18O
Molecular weight: 154.251 g/mol
substance type: organic
Physical state: liquid
InChI:1S/C10H18O/c1-5-10(4,11)8-6-7-9(2)3/h5,7,11H,1,6,8H2,2-4H3
Smiles:C([C@@](C=C)(C)O)C\C=C(\C)C

Specific details on test material used for the study:

IUPAC name: (3S)-3,7-dimethylocta-1,6-dien-3-ol
commen name: Linalool
Molecular formula :C10H18O
Molecular weight: 154.251 g/mol
substance type: organic
Physical state: liquid
InChI:1S/C10H18O/c1-5-10(4,11)8-6-7-9(2)3/h5,7,11H,1,6,8H2,2-4H3
Smiles:C([C@@](C=C)(C)O)C\C=C(\C)C

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

No data available

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

Amount-01ml
Concentration-100%, 30%,10%

Duration of treatment / exposure:

Not specified

Observation period (in vivo):

Not specified

Number of animals or in vitro replicates:

Total=6

Details on study design:

Not specified

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: Not specified

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Irritation was moderate at 100%, slightly at 30%; very slightly at 10%

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

(3S)-3,7-dimethylocta-1,6-dien-3-ol when subjected to 6 New Zealand white rabbits in concentration 100%, 30% and 10% produced positive ocular irritation effects . Hence, (3S)-3,7-dimethylocta-1,6-dien-3-ol was considered to be eye irritant.

Executive summary:

(3S)-3,7-dimethylocta-1,6-dien-3-ol was used as test material to evaluate its eye irritation potential on 6 New Zealand white rabbits.

The test material was subjected to the conjunctive sac of rabbit in the concentration 0.1 ml (100%, 30% and 10%).

Irritation was moderate at 100%, slightly at 30%; very slightly at 10%. As all the above concentrations produced positive ocular irritation reactions. Hence, (3S)-3,7-dimethylocta-1,6-dien-3-ol was considered to be eye irritant.