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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication/ study report which meets basic scientific principles
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
other company data
Title:
Unnamed
Year:
1978
Report date:
1978
Reference Type:
secondary source
Title:
Acute toxicity studies on 6,10-dimethyl-5,9-undecadien-2-one
Author:
BASF AG
Year:
2008
Bibliographic source:
RIFM database
Report date:
1978

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal Register 38 No 187 §1500.41 (Haut) und §1500.42 (Auge), S. 27019 vom 27.09.73.
Principles of method if other than guideline:
Method acc. Draize, J.H. (1959):
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
6,10-dimethylundeca-5,9-dien-2-one
EC Number:
211-711-2
EC Name:
6,10-dimethylundeca-5,9-dien-2-one
Cas Number:
689-67-8
Molecular formula:
C13H22O
IUPAC Name:
6,10-dimethylundeca-5,9-dien-2-one
Details on test material:
- Name of test material (as cited in study report): Geranylaceton R
- Substance No.: 77/274
- Analytical purity: min. 99%

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
one single application, test substance remains in eye
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM:
- scoring after Draize (1959):

Chemosis (Swelling) and cornea (Opacity):
0 = none
1 = slight
2 = well defined
3 = severe
4 = very severe

Area of cornea involved (Area):
1 = > 0; < 0.25
2 = >= 0.25 , < 0.5
3 = >= 0.5 < 0.75
4 = >= 0.75

Conjunctival redness (Redness):
0 = normal
1 = slight
2 = well defined
3 = severe

Discharge:
0 = normal
1 = slightly increased
2 = clearly increased
3 = distinctly increased

Iris:
0 = normal
1 = circum-corneal injection
2 = iritis

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.44
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effect
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.7
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect

Any other information on results incl. tables

Results:

Rabbit no. 24 hours 48 hours 72 hours
1 2 3 4 5 6 1 2 3 4 5 6 1 2 3 4 5 6
1. Cornea: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
A.) Opacity
Cornea: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
B.) Area
a=AxBx5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
(Max. 80)
2. Iris (A) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
b=Ax5  0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
(Max. 10)
3. Conjuctivae                                    
A.) Redness 1 1 0 1 1 1 1 1 0 1 1 1 1 1 0 0 1 0
B.) Chemosis 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
C.) Discharge 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
c=(A+B+C)x2 (Max. 20) 2 2 0 2 2 2 2 2 0 2 2 2 2 2 0 0 2 0
Total = a+b+c (Max. 110) 2 2 0 2 2 2 2 2 0 2 2 2 2 2 0 0 2 0

=> primary irritation index: 26/18 = 1.44

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU