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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-10-24 to 2000-10-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl phenylacetate
EC Number:
202-940-9
EC Name:
Methyl phenylacetate
Cas Number:
101-41-7
Molecular formula:
C9H10O2
IUPAC Name:
methyl phenylacetate

Test animals / tissue source

Species:
rabbit
Strain:
other: Chbb:HM(SPF) - Littlerussian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: BI Pharma KG, 88397 Biberach
- Weight at study initiation: 2.2 - 2.7 kg bw
- Housing: Animal room No. 4 provided with filtered air. During a pre-period of at least one week and throughout the experiment the rabbits were caged individually in PPO cages (floor area: 2576 sq.cm) with perforated floor.
- Diet: A pelleted complete rabbit diet "Altromin 2123" from Altromin, D-32791 Lage, Lippe, was available ad libitum. Analyses for major nutritive cornponents and relevant possible contaminants are performed regularly on the diet. Certificates of analysis are retained.
- Water: The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth. Analyses for relevant possible contaminants are performed regularly. Certificates of analysis are retained.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes: 10 times/hour
- Photoperiod: Cycle of 12 hours light and 12 hours darkness

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Other eye served as control
Amount / concentration applied:
Test substance was applied undiluted: 0.1 mL
Duration of treatment / exposure:
Single treatment
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
4 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: With 20 mL 0.9 % sodium chloride solution
- Time after start of exposure: After 24 h

SCORING SYSTEM: According to Draize et al.

TOOL USED TO ASSESS SCORE: Fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 4
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 2,3,4
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A test was conducted to assess the eye irritating potential of the test item to rabbits eye. As a result the test item was considered to be not eye irritating.
Executive summary:

The local effect of the test item was investigated according to the method recommended in the OECD Guideline No. 405 and according to method B.5 "Acute Toxicity (Eye Irritation)", Jan. 1997. Four female albino rabbits were exposed to 0.1 mL of the test article, applicated undiluted in one eye. The eyes were examined and the changes were graded according to a numnerical scale one hour, 24, 48 and 72 hours after dosing. The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated:

Cornea: 0 (all animals)

Iris: 0 (all animals)

Conjunctiva: 0.33, 0, 0.67, 0.33

Chemosis: 0.33, 0, 0, 0

All results were fully reversible. In conclusion the test item causes no eye irritation.