Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
weight of evidence
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draize test
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Linalool
EC Number:
201-134-4
EC Name:
Linalool
Cas Number:
78-70-6
Molecular formula:
C10H18O
IUPAC Name:
3,7-dimethylocta-1,6-dien-3-ol

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
several seconds to allow the liquid to mix with the eye fluids
Observation period (in vivo):
24h, 48 h, 72h and at day 4 and day 7
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
27
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
16
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
10
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4 days
Score:
6
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
7 d
Score:
0

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Linalool is classified as a eye irritant substance according to CLP and GHS criteria.
No study was conducted on the lavandin oil light fraction iself.
The test item is a natural complex substance (NCS). It is a mixture of several constituents, and linalool represents 65% of this UVCB substance.
Literature above provided data for this major compound.
Hence, lavandin oil light fraction is classified as a eye irritant substance according to CLP and GHS criteria.