Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983-04-19 to 1983-04-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
cyclooctene of Hüls AG; purity: 92.7 %

Test animals / tissue source

Species:
rabbit
Strain:
other: Small white Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Sex: male/female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 2.3 - 2.5 kg
- Number of animals: 3 males, 3 females
- Water: ad libitum
- Diet: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +/- 1 °C
- Humidity (%): 60 % +/- 5%
- Air changes (per hr): 15 times/hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark rythm

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
not rinsed
Observation period (in vivo):
1, 24, 48, and 72 hours after treatment
Number of animals or in vitro replicates:
6
Details on study design:
Comment: not rinsed
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, and 72 hours after treatment
- Scoring system: Draize (1959); evaluation: VCI notes on safety data  sheet
- Tool used to assess score: sodium fluorescein / ophthalmic lamp /  visual inspections

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
2.5
Max. score:
110
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
2.5
Max. score:
20
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0/80
- Iris: 0/10
- Conjunctivae: 2.50/20
- Overall irritation score: 2.50/110
Other effects:
REVERSIBILITY: complete within 72 hours

Applicant's summary and conclusion

Conclusions:
In this study, cyclooctene was not an eye irritant..
Executive summary:

In a primary eye irritation study 0.1 mL of undiluted cyclooctene was instilled into the conjunctival sac of one eye of three male and three female young adult White Russian rabbits. Eyes were not rinsed. Animals were observed for 3 days. 

Cornea and iris were not affected. Very mild and reversible conjunctival effects were observed. In this study, cyclooctene was not an eye irritant..