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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From Feb. 12, 1990 to Jul. 20, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981, updated guideline adopted 1987
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Isobutyrophenone
EC Number:
210-275-0
EC Name:
Isobutyrophenone
Cas Number:
611-70-1
Molecular formula:
C10H12O
IUPAC Name:
2-methyl-1-phenylpropan-1-one
Details on test material:
- Name of test material (as cited in study report): Darocur 1173, stage 1
- Physical state: Liquid
- Lot/batch No.: Beleg 281

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: 20 to 21 weeks
- Weight at study initiation: 3.03 to 3.20 kg (mean weight of 3.11)
- Housing: Housed separately in cages type KK 017
- Diet (e.g. ad libitum): Altromin standard diet TPF 2113, pellets ad libitum
- Water (e.g. ad libitum): acidified, fully demineralized water, ad libitum
- Acclimation period: minimum of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 26
- Humidity (%): 41 to 58
- Photoperiod (hrs dark / hrs light): not reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
1 male and 2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE: Rinsing of the eye was not performed.
SCORING SYSTEM: Same scale as the one provided in the OECD guideline 405.
TOOL USED TO ASSESS SCORE: not reported

The rabbits were investigated for eye irritation and for changes in behavior and general condition 1 hour after treatment and then daily for a period of further 7 days. All rabbits were weighed before the start of the study and on days 5 and 8. Local changes of the eye were evaluated according to the recommendations of the OECD (in addition, observations for discharge were reported).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: Day 1 (1 hour) and Day 2
Score:
1
Max. score:
4
Reversibility:
fully reversible within: Day 3
Remarks on result:
other: Refer to attached table 2 for full details
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: Day 1 (1 hour)
Score:
1
Max. score:
4
Reversibility:
fully reversible within: Day 2
Remarks on result:
other: Refer to attached table 2 for full details
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: Day 1 (1 hour)
Score:
1
Max. score:
4
Reversibility:
fully reversible within: Day 2
Remarks on result:
other: Refer to attached table 2 for full details
Irritation parameter:
other: Discharge
Basis:
animal #1
Time point:
other: Day 1 (1 hour)
Score:
2
Max. score:
3
Reversibility:
fully reversible within: Day 2
Remarks on result:
other: Refer to attached table 2 for full details
Irritation parameter:
other: Discharge
Basis:
animal #2
Time point:
other: Day 1 (1 hour)
Score:
2
Max. score:
3
Reversibility:
fully reversible within: Day 2
Remarks on result:
other: Refer to attached table 2 for full details
Irritation parameter:
other: Discharge
Basis:
animal #3
Time point:
other: Day 1 (1 hour)
Score:
2
Max. score:
3
Reversibility:
fully reversible within: Day 2
Remarks on result:
other: Refer to attached table 2 for full details
Irritant / corrosive response data:
After single instillation of 0.1 mL Isobutyrophenone into the conjunctival sac of the left eye, without rinsing, very slight redness (value 1) of the conjunctivae was observed in all 3 animals 1 hour after instillation and only in 1 rabbit up to day 2 of the study. No other signs of primary eye irritation according to the OECD rating were observed. All rabbits showed discharge without chemosis at the first reading. Refer to attached table 2 for full details.
Other effects:
No signs of systemic toxicity were seen. The body weight development corresponded to that of untreated rabbits of the same age. All animals survived the 7-day observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU