Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
Existing in vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 June to 30 June 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study carried out in accordance with OECD 405 (1987) and performed with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-hydroxypropyl 2-ethylhexanoate
EC Number:
261-499-0
EC Name:
2-hydroxypropyl 2-ethylhexanoate
Cas Number:
58921-10-1
Molecular formula:
C11H22O3
IUPAC Name:
2-hydroxypropyl 2-ethylhexanoate
Constituent 2
Chemical structure
Reference substance name:
1-hydroxypropan-2-yl 2-ethylhexanoate
Molecular formula:
C11H22O3
IUPAC Name:
1-hydroxypropan-2-yl 2-ethylhexanoate
impurity 1
Chemical structure
Reference substance name:
Monoesters of 2-ethylhexanoic acid and dipropyleneglycol
IUPAC Name:
Monoesters of 2-ethylhexanoic acid and dipropyleneglycol
impurity 2
Chemical structure
Reference substance name:
1-methylethylene 2-ethylhexanoate
EC Number:
301-185-3
EC Name:
1-methylethylene 2-ethylhexanoate
Cas Number:
93981-97-6
Molecular formula:
C19H36O4
IUPAC Name:
propane-1,2-diyl bis(2-ethylhexanoate)
impurity 3
Chemical structure
Reference substance name:
2-ethylhexanoic acid
EC Number:
205-743-6
EC Name:
2-ethylhexanoic acid
Cas Number:
149-57-5
Molecular formula:
C8H16O2
IUPAC Name:
2-ethylhexanoic acid
impurity 4
Reference substance name:
Propane-1,2-diol, propoxylated
EC Number:
500-039-8
EC Name:
Propane-1,2-diol, propoxylated
Cas Number:
25322-69-4
IUPAC Name:
Propane-1,2-diol, propoxylated
impurity 5
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
Water
Test material form:
liquid: viscous
Specific details on test material used for the study:
- Name of test material (as cited in study report): SER-AD FX 511
- Physical state: liquid (very pale yellow)
- Analytical purity: no data; the purity of the test material was the responsibility of the sponsor
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 w
- Weight at study initiation: 2.88 to 3.10 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 45-64
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
VEHICLE no vehicle used
Duration of treatment / exposure:
1 h
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
3 (1 female, 2 males)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed, but it is not considered necessary
The eyes of the animals were examined 1, 24, 48, and 72 h after the test substance application. The light source from a standard ophthalmoscope was used.

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: The light source from a standard ophthalmoscope was used to enable the assessment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.2
Max. score:
1
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Irritant / corrosive response data:
No corneal effects were detected. The iris appeared inflammed in one animal at 1 h post-treatment, but it was fully reversible within 24 h. Minimal irritation of the conjuctivae was seen in two animals at 24 h.

Any other information on results incl. tables

Individual irritation scores can be found in the attached document below.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not an eye irritant.
Executive summary:

In this eye irritation study, 0.5 ml of SER-AD FX 511 was instilled into the conjunctival sac of the right eye of 3 young adult New Zealand White rabbits (1 female and 2 males). Animals were then observed for the following 72 h. Irritation was scored using the Draize scheme for unwashed eyes at time point of 24, 48 and 72 h post-treatment. No corneal effects were detected. The iris appeared inflammed in one animal at 1 h post-treatment, but it was fully reversible within 24 h. Minimal irritation of the conjuctivae was seen in two animals at 24 h. SER-AD FX 511 induced slight irritation that was reversed during the study period. On the basis of this study, SER-AD FX 511 does not warrant classification as being an eye irritant.