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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
Study period:
10 Jul - 17 Jul 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. Few details on the test substance were given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted Feb 1987
Deviations:
yes
Remarks:
lack of details on test substance
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
lack of details on test substance
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C16-18, isotridecyl esters
EC Number:
306-084-8
EC Name:
Fatty acids, C16-18, isotridecyl esters
Cas Number:
95912-88-2
Molecular formula:
C29H58O2 and C31H62O2
IUPAC Name:
Fatty acids, C16-18, isotridecyl esters
Details on test material:
- Name of test material (as cited in study report): isotridecylstearat
- Physical state: colourless liquid
- Date of arrival: 18 May 1987
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
other: Kleinrusse Chbb:HM
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Weight at study initiation: 2245 g (average)
- Housing: single housing in rabbit cages, (Fa. Henkel, Kuchen, Germany)
- Diet: Altromin feed 2023 (Fa. Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 20-21
- Humidity (%): approximately 45-55
- Photoperiod (hrs dark / hrs light):12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single application without washing
Observation period (in vivo):
72 h
Reading time points: 1, 6, 24, 48 and 72 h
Number of animals or in vitro replicates:
4 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not washed

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all 4 animals
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all 4 animals
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of all 4 animals
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all 4 animals
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
1 hour after instilling the test substance in the eyes, 1/4 rabbits had a slight discharge (grade 1 of 3) and 2/4 severe discharge (grade 3) from the treated eye, while 3/4 rabbits showed slight redness of the eye (grade 1 of 3). At the 6-hour reading time point, 3/4 rabbits showed slight redness and 1/4 still had severe discharge from the eye. These effects cleared completely within 24 hours and none of the animals had eye irritation effects at reading time points 24, 48 and 72 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified