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Toxicological information

Eye irritation

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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: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 2012
Deviations:
yes
Remarks:
no pretreatment with topical anesthetics and systemic analgesics; 6 animals
GLP compliance:
no
Remarks:
study performed prior to implementation of GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
Octa-1,7-diene
EC Number:
223-054-9
EC Name:
Octa-1,7-diene
Cas Number:
3710-30-3
Molecular formula:
C8H14
IUPAC Name:
octa-1,7-diene

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: H. Fortkamp, Lengerich, Germany
- Age at study initiation: 11 - 17 weeks
- Weight at study initiation: 2.45 - 2.94 kg
- Housing: individually in steel grid floor cages
- Diet: Ssniff K Alleindiaet fuer Kaninchen (Ssniff Versuchstier GmbH, Soest, Germany); ad libitum
- Water: mains water; ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 40 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated right eye of each animal served as control.
Amount / concentration applied:
undiluted
Amount applied: 0.1 mL
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
7 days
Reading time points: 1 h and 1, 2, 3, 4 and 7 days after application
Number of animals or in vitro replicates:
6 males
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS EYES: fluorescein (before treatment)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: 1-h reading: score = 1
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of 4 animals (#2-#5)
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: 1-h reading: score = 1 in 2/4 animals; score = 2 in 2/4 animals
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: mean over 24, 48 and 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 1-h reading: score = 1
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: 1-h reading: score = 1 in 4/6 animals; score = 2 in 2/6 animals
Irritant / corrosive response data:
One hour after instillation of the test substance moderate chemosis (grade 2) associated with moderate reddening (grade 2) were observed in 2/6 animals. In the remaining 4 animals slight chemosis (grade 1) and slight reddening (grade 1) were noted. One day after treatment chemosis was no longer apparent in any animal and eye reaction was limited to slight reddening (grade 1) in the majority of animals. Two days after treatment only one animal showed slight reddening (grade 1) and 3 days after treatment no longer any effects were observed.
Other effects:
Initial pain reaction on instillation varied from practically no initial pain (a few blinks only; normal within one or two minutes) to slight initial pain (rabbit blinks and tries to open eye, but the reflexes close it).

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Slight eye irritating effects (conjunctivae redness and swelling) were observed in all animals after instillation of the test substance. Almost all effects were reversible within 24 h and not later than 48 h. Thus, classification for eye irritation is not warranted.