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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

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 and well documented publication, no GLP study, equivalent to guideline, only a 20 % mixture of the test substance was tested

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2-dimethyl-3-phenylpropanol
EC Number:
236-400-9
EC Name:
2,2-dimethyl-3-phenylpropanol
Cas Number:
13351-61-6
Molecular formula:
C11H16O
IUPAC Name:
2,2-dimethyl-3-phenylpropan-1-ol

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.4 - 2.6 kg
- Housing: single cages
- Diet: Muemml Z, Plange
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 45-55
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
other: peanut oil
Controls:
other: right eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL of the 20 % pure test substance
Observation period (in vivo):
1, 2, 8 hours and 1, 2, 3, 4, 5, 6 and 7 days after application
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
SCORING SYSTEM: According to Draize et al.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48. 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The eye irritation potential was determined in a study equivalent to OECD guideline 405. Cornea, Iris, conjunctiva and chemosis scores were 0. No eye irritation effects were observed.
Executive summary:

In a study equivalent to OECD guideline 405 the eye irritation with 6 New Zealand rabbits was tested. The test item was applied in an amount of 0.1 mL. Only a 20 % mixture of the test substance was tested. The room temperature was kept constantly at 20 °C with the relative humidity verying between 45 and 55 %. The duration of lighting was 12 hours/day. The animals were observed over a period of 1, 2, 8 hours and 1, 2, 3, 4, 5,6 and 7 days after application. The right eye served as control. Eye irritation was evaluated according to the criteria of Draize et al.

The mean scores at 24, 48 and 72 h for all animals were as following:

Cornea: 0

Iris: 0

Conjunctivae: 0

Chemosis: 0

No eye irritation effects were observed.