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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: According to guideline study (OECD 405)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Isododecene

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Savo; med. Versuchstierzuchten GmbH, 7964 Kisslegg
- Weight at study initiation: Animal 1 (male) - 3.22 kg; Animal 2 (female) - 3.33 kg; Animal 3 (female) - 3.61 kg
- Housing: 1 animal per cage, in cages made of stainless steel with wire mesh walk floors
- Diet (e.g. ad libitum): about 130 g per animal per day (KLIBA 341)
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: at least 8 days (same housing conditions as during the study)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12
There were no deviations from these ranges which influenced the results of the study

Animal identification: ear tattoo


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted

Application: single application to the conjunctival sac of the right eyelid

Duration of treatment / exposure:
The test substance was not washed out
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 (1 male and 2 females)
Details on study design:
SCORING SYSTEM: Draize score
Readings: 1 h, 24 h, 48 h and 72 h after application
(For calculation of the means of opacity, iris, redness and swelling only the readings of 24, 48 and 72 hours are used)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 - 72 hours
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 - 72 hours
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 - 72 hours
Score:
0.3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0.4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0

Any other information on results incl. tables

No need for labelling according to Directive 67/548 and GHS (UN, 2007)

Applicant's summary and conclusion