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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD)

Data source

Referenceopen allclose all

Reference Type:
other company data
Title:
Unnamed
Year:
1990
Report date:
1990
Reference Type:
secondary source
Title:
No information
Author:
BASF AG
Year:
2000
Bibliographic source:
ECB IUCLID dataset

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
6,10-dimethylundeca-3,5,9-trien-2-one
EC Number:
205-457-1
EC Name:
6,10-dimethylundeca-3,5,9-trien-2-one
Cas Number:
141-10-6
IUPAC Name:
6,10-dimethylundeca-3,5,9-trien-2-one
Details on test material:
- Name of test material (as cited in study report): 2-Pseudojonon
- Lot/batch No.: 89/844; continous production

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, Germany
- Weight at study initiation: male 2.73; females 3.13 kg and 2.83 kg
- Animal identification: ear tattoo
- Housing: individually in cages made of stainless steel with wire mesh walk floors, floor area 40x51 cm; no bedding in cages, but saw dust in waste trays
- Diet (e.g. ad libitum): Kliba 341 4mm; ca. 130 g/animal/day; Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water (e.g. ad libitum): tap water; ca. 250 ml/animal/day
- Acclimation period: at least 8 days; same housing conditions as during study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

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 application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
1 male, 2 female
Details on study design:
APPLICATION
- single application to the conjunctival sac of the right eyelid

SCORING
- Time schedule: 1, 24, 48, 72 h, 8 d after application
- Scale for scoring ocular lesions:

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

Calculation of the mean acc. to 83/467/EEC criteria of july 29th, 1983.



Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.7
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 28, 72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

Animal 1: female (3.13 kg)

Animal 2: male (2.73 kg)

Animal 3: female (2.83 kg)

Results:

Readings Animal cornea Iris conjunctiva Symptons
opacity area redness swelling discharge
1h 1 0 0 0 2 0 1  
2 0 0 0 2 1 2  
3 0 0 0 2 1 2  
24 h 1 1 1 0 2 1 1  
2 0 0 0 2 1 1  
3 0 0 0 2 1 0  
48 h 1 0 0 0 2 1 0  
2 0 0 0 1 0 0  
3 0 0 0 2 0 0  
72 h 1 0 0 0 2 0 0  
2 0 0 0 0 0 0  
3 0 0 0 2 0 0  
8 d 1 0 0 0 0 0 0  
2 0 0 0 0 0 0  
3 0 0 0 0 0 0  
Mean 24 - 72 h 1 0.3 0.3 0.0 2.0 0.7 0.3  
2 0.0 0.0 0.0 1.0 0.3 0.3  
3 0.0 0.0 0.0 2.0 0.3 0.0  
Mean   0.1 0.1 0.0 1.7 0.4 0.2  

Applicant's summary and conclusion

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