Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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: Well documented study following standard guidelines and performed following GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Versatic 10
- Substance type: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, the Netherlands
- Age at study initiation: young adult
- Weight at study initiation: 2120-2350 g
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 62.5 - 75
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): n/a
Duration of treatment / exposure:
Material was instilled into the eye and held shut for one second
Observation period (in vivo):
1 h, 24 h, 48 h, 72 h after treatment
Number of animals or in vitro replicates:
2 rabbits
Details on study design:
SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hour average
Score:
0.67
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
other: edema
Basis:
mean
Time point:
other: 24, 48, and 72 hour average
Score:
0.33
Reversibility:
fully reversible within: 72 hours

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Versatic 10 was slightly, but transiently, irritating to the rabbit eye.
Executive summary:

Versatic 10 (neodecanoic acid) was tested for eye irritancy in one eye of each of three rabbits. Eye responses were scored at 1, 24, 48, and 72 hours after treatment according to the method of Draize. At 1 hour after treatment, animals showed slight redness of the conjunctivae, slight to moderate swelling and slight to moderate discharge. One animal showed slight iritis. In all animals, recovery was advanced by 48 hours after treatment and the remaining eye responses had resolved completely by 72 hours after treatment. The overall mean scores were:

Opacity: 0

Iris: 0

Redness: 0.67

Edema: 0.33