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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 Aug 2007- 19 Sep 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: ICCVAM: NIH Publication No: 06-4515
Principles of method if other than guideline:
There are no official guidelines for the HET-CAM Test; however, the study was conducted according to the following publications:
- Lüpke N.P. (1985): Hen’s Egg Chorioallantoic Membrane Test for Irritation Potential. Fd. Chem. Toxic. 23, pp. 287 – 291.
- Spielmann, H. (1995): HET-CAM Test. In: Methods in Molecular Biology, 43 (eds.:O’Hare, S. and Atterwill, C. K.) pp. 199 – 204.
- Spielmann, H. et al. (1996): Results of a Validation Study in Germany on Two In Vitro Alternatives to the Draize Eye Irritation Test the HET-CAM Test and the 3T3 NRU Cytotoxicity Test. ATLA 24, pp. 741 – 858.

The testing strategy was followed according to OECD Guideline 405.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol
EC Number:
272-379-2
EC Name:
9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol
Cas Number:
68815-51-0
Molecular formula:
C18 H34 O2 . C4 H12 N2 O
IUPAC Name:
2-(2-aminoethylamino)ethanol; (Z)-octadec-9-enoic acid
Details on test material:
- Name of test material (as cited in study report): Kerocom F 100; Test-substance No.: 07/0395-1
- Physical state: solid (melt)
- Analytical purity: 100 %
- Purity test date: 18.06.07
- Lot/batch No.: GV33754-L2927
- pH-value: ca. 5 (undiluted test substance)
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor.
- Storage condition of test material: room temperature
- Homogeneity: The test substance was homogeneous by visual inspection.

Test animals / tissue source

Species:
other: hen egg
Strain:
other: White Leghorn
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: SPAFAS Inc. USA, Charles River Deutschland GmbH, Extertal, Germany
- Weight at study initiation: 56.2 g-57.9 g

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37.5
- Humidity (%): 62.5
- Automatic rotating device: 5 times a day until day 8 and/or day 9 of incubation (inclusively)

Test system

Vehicle:
other: olive oil Ph.Eur./DAB
Controls:
yes, concurrent positive control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.3 ml
- Concentration (if solution): undiluted and 10% in olive oil
Duration of treatment / exposure:
3.5 min
Observation period (in vivo):
3.5 min
Number of animals or in vitro replicates:
3 eggs per concentration (undiluted and 10%)
Details on study design:
SCORING SYSTEM:

0 No visible change
1 Slight reaction
2 Moderate reaction
3 Severe reaction
Any further findings not covered by this scale were described in the raw data.


Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
other: Haemorrhagia
Remarks:
Mean of grading of effects
Run / experiment:
undiluted test substance
Value:
0
Positive controls validity:
valid
Irritation parameter:
other: Coagulation
Remarks:
Mean of grading of effects
Run / experiment:
undiluted test substance
Value:
0
Positive controls validity:
valid
Irritation parameter:
other: Haemorrhagia
Remarks:
Mean of grading of effects
Run / experiment:
10% test substance in olive oil
Value:
0
Positive controls validity:
valid
Irritation parameter:
other: Coagulation
Remarks:
Mean of grading of effects
Run / experiment:
10% test substance in olive oil
Value:
0
Positive controls validity:
valid

Any other information on results incl. tables

Results observed with the test substance

Concentration

Egg-No.

observation period (sec)

Grading of effects

Additional findings

Haemorrhagia

Coagulation

Haemorrhagia

Coagulation

Undiluted

test

substance

1

210

210

0

0

none

2

210

210

0

0

none

3

210

210

0

0

none

Mean

1-3

210

210

0

0

none

Concentration

Egg-No.

observation period (sec)

Grading of effects

Additional findings

Haemorrhagia

Coagulation

Haemorrhagia

Coagulation

Test substance 10% in olive oil

1

210

210

0

0

none

2

210

210

0

0

none

3

210

210

0

0

none

Mean

1-3

210

210

0

0

none

Positive controls:

Concentration

Egg-No.

Time (sec) until appearance of

Grading of effects

Additional findings

Haemorrhagia

Coagulation

Haemorrhagia

Coagulation

0.1 M NaOH

1

18

36

2

2

iv

2

20

37

2

2

iv

Mean

1-2

19

37

2

2

iv: intravascular coagulation

Concentration

Egg-No.

Time (sec) until appearance of

Grading of effects

Additional findings

Haemorrhagia

Coagulation

Haemorrhagia

Coagulation

1% SDS

1

39

53

2

2

iv,ev

2

38

50

2

2

iv, ev

Mean

1-2

39

52

2

2

iv: intravascular coagulation

ev: extravascular coagulation

Applicant's summary and conclusion

Interpretation of results:
other: No serious eye damage