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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011

Materials and methods

Principles of method if other than guideline:
In vitro study for assessing ocular irritation of compounds using a human epithelial corneal cell model. The model used is standardized and commercially available (SkinEthic™ Human Corneal Epithelial Model (HCE); SkinEthic, France).
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-phosphonobutane-1,2,4-tricarboxylic acid
EC Number:
253-733-5
EC Name:
2-phosphonobutane-1,2,4-tricarboxylic acid
Cas Number:
37971-36-1
Molecular formula:
C7H11O9P
IUPAC Name:
2-phosphonobutane-1,2,4-tricarboxylic acid
Details on test material:
Content: P-P-Acid 0.29 %
Ketone 2.41 %
PBS-AM 85.95 %
M-M-PBS-AM 0.51 %
PBS 3.95 %
H3PO3 0.16 %
H3PO4 0.26 %

Test animals / tissue source

Species:
other: not applicable - human corneal epithelial model (HCE)
Strain:
other: not applicable - human corneal epithelial model (HCE)

Test system

Vehicle:
other: not applicable - human corneal epithelial model (HCE)
Controls:
other: not applicable - human corneal epithelial model (HCE)
Duration of treatment / exposure:
After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was measured
Observation period (in vivo):
not applicable - human corneal epithelial model (HCE)
Number of animals or in vitro replicates:
not applicable - human corneal epithelial model (HCE)

Results and discussion

In vivo

Results
Irritation parameter:
other: cell viability
Basis:
mean
Time point:
other: 60 minutes followed by a 16 h post-treatment period
Score:
1.98
Max. score:
100
Reversibility:
other: not applicable - human corneal epithelial model (HCE)
Remarks on result:
other: irritant - scores in [%] viability

Any other information on results incl. tables

A test substance is predicted to be an ocular irritant if the mean relative tissue viability (%) exposed to the test substance is<50%.

As can be seen from the information in the Table below the test substance

Bayhibit AM wasserfrei was detected as irritant to the cornea epithelium in this test model.

Compound Cell viability [%] Evaluation

Bayhibit AM wasserfrei               1.98        irritant

Positive control                             28.91      irritant

Negative control                      100.00 non-irritant

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Executive summary:

This in vitro study for assessing ocular irritation of compounds using a human epithelial corneal cell model was performed in 2011. The model used is standardized and commercially available (SkinEthicTM Human Corneal Epithelial Model (HCE); SkinEthic, France).

Undiluted Bayhibit AM wasserfrei was applied topically to the HCE tissue, i.e. 30 mg per insert. (plus 30 µl PBS to moisten and ensure good contact with the skin; three replicates)

After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was 2% (rounded) as measured by a MTT conversion assay.

The results of the concurrent negative (NC, PBS) and positive control

(PC, 1H-1,2,4-Triazole-3-thiol) demonstrated the viability (NC) and sensitivity (PC) of the test model.

The results show that Bayhibit AM wasserfrei is predicted as ocular irritant under the conditions of this test method.

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