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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
BASF-Test, no guideline available at that time.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7,11,15-tetramethylhexadec-1-en-3-ol
EC Number:
208-008-8
EC Name:
3,7,11,15-tetramethylhexadec-1-en-3-ol
Cas Number:
505-32-8
Molecular formula:
C20H40O
IUPAC Name:
3,7,11,15-tetramethylhexadec-1-en-3-ol
Details on test material:
- Name of test material (as cited in study report): Isophytol G
- Physical state: fluid
- Analytical purity: ca. 90 %
- Impurities (identity and concentrations): not reported

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.01 and 1.92 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: NaCl-treated eye of the same animals served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
- Concentration (if solution): undiluted
Duration of treatment / exposure:
not removed
Observation period (in vivo):
3 days (free of symptoms)
Number of animals or in vitro replicates:
2 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed out

TOOL USED TO ASSESS SCORE: fluorescein (72h after test substance administration)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 3 days

Any other information on results incl. tables

One hour after application slight erythema of the conjunctiva (some vessels definitely injected; Draize 1) was found, 24 hours after application slight erythema of the conjunctiva (Draize 1) and slight corneal opacity (Draize 1) were observed, but 2 and 3 days after application, respectively, the symptoms had subsided, and observation was stopped. No effects on the iris or chemosis were reported in this study.

NaCl-treated control eyes were without symptoms during the whole obsevation period. Reported findings in the investigation were converted to Draize scores according to Grundler (1983).

Findings at different timepoints after test substance application, converted to Draize scores:

      1 h     24 h     48 h     72 h
 Irritation parameter  #1  #2  #1  #2  #1  #2  #1  #2
 Cornea  0  0  1  1  0  1  0  0
 Conjunctiva erythema  1  1  1  1  0  1  0  0

# animal number

Applicant's summary and conclusion