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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
HET-CAM-Test
- Short description of test conditions: treatment of eggs with undiluted test substance and test substance 10 % in olive oil
- Parameters analysed / observed: time until onset of haemorrhagia, lysis, coagulation
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
6,10-dimethylundecan-2-one
EC Number:
216-509-8
EC Name:
6,10-dimethylundecan-2-one
Cas Number:
1604-34-8
Molecular formula:
C13H26O
IUPAC Name:
6,10-dimethylundecan-2-one
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Tetrahydrogeranylaceton
- Substance No.: 01/0275-1
- Batch-Nr.: B 633
- Purity: 97.5 area% (GC)
- Date of production: 17 Oct 2000
- Substance type: Liquid / colourless - clear
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: BASF, Batch No. B 633

Test animals / tissue source

Species:
other: chorioallantoic membrane of hen´s egg (HET-CAM) Test

Test system

Vehicle:
other: undiluted and 10 % in olive oil Ph.Eur./DAB
Controls:
yes, concurrent positive control
Amount / concentration applied:
TEST MATERIAL
- undiluted
- Concentration (if solution): 100%, 10%
Duration of treatment / exposure:
5 minutes
Observation period (in vivo):
not applicable
Number of animals or in vitro replicates:
3 eggs per dose group
Details on study design:
- Doses of test chemical and control substances used:
- test chemical: undiluted test substance and test substance 10 % in olive oil
- positive control: 0,1 N NaOH and 1 % SDS
- Duration of exposure: 301 s (5 min)
- Number of tissue replicates used per test chemical and controls (positive control): 3 eggs

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
other: Time (s) until appearance of haemorrhagia
Remarks:
undiltuted substance
Run / experiment:
mean of three eggs
Value:
301
Vehicle controls validity:
not examined
Negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: evaluated as no serious damage to eyes
Irritation parameter:
other: Time (s) until appearance of lysis
Remarks:
undiluted substance
Run / experiment:
mean of three eggs
Value:
301
Vehicle controls validity:
not examined
Negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: evaluated as no serious damage to eyes
Irritation parameter:
other: Time (s) until appearance of coagulation
Remarks:
undiluted substance
Run / experiment:
mean of three eggs
Value:
150.7
Vehicle controls validity:
not examined
Negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: evaluated as no serious damage to eyes
Irritation parameter:
other: Time (s) until appearance of haemorrhagia
Remarks:
Dilution of 10% in olive oil
Run / experiment:
mean of three eggs
Value:
301
Vehicle controls validity:
not examined
Negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: evaluated as no serious damage to eyes
Irritation parameter:
other: Time (s) until appearance of lysis
Remarks:
Dilution of 10% in olive oil
Run / experiment:
mean of three eggs
Value:
301
Vehicle controls validity:
not examined
Negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: evaluated as no serious damage to eyes
Irritation parameter:
other: Time (s) until appearance of coagulation
Remarks:
Dilution of 10% in olive oil
Run / experiment:
mean of three eggs
Value:
301
Vehicle controls validity:
not examined
Negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: evaluated as no serious damage to eyes
Other effects / acceptance of results:
The summary report does not state critiera for acceptance or interpretation of results.

Any other information on results incl. tables

Mean time (sec) until appearance of
test substance Haemorragia Lysis Coagulation Index for irritation
10% 301 301 301 0
100% 301 301 150.7 4.5
 0.1 N NaOH  23  301 45,5   12,3
 1% SDS  45,3  301  75,0  11,0

0.1 N NaOH: Intravascular coagulation

1% SDS: Extra and intravascular coagulation

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Procedure only excludes potential for severe eye irritation
Conclusions:
Based on these results it was concluded that the test substance Tetrahydrogeranylaceton does not represent a risk of serious damage to the eyes.
Executive summary:

Fertilized eggs were incubated for 9-10 days. Then the eggs were opened and the CAM exposed. The undiluted test substance and a 10 % dilution in olive oil Ph.Eur./DAB were tested in 3 replicates each. The time until effects were observed was measured. Recorded effects were haemorrhagia, lysis and coagulation.