Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan to July 2018
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Condensation products of N-(6-aminohexyl)-12-hydroxyoctadecanamide and sebacic acid
EC Number:
945-990-3
IUPAC Name:
Condensation products of N-(6-aminohexyl)-12-hydroxyoctadecanamide and sebacic acid
Test material form:
solid: particulate/powder

Test system

Vehicle:
other: corn oil
Controls:
yes, concurrent vehicle
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
750 μL of the prepared test item [20% (w/v) concentration in corn oil],positive control [750 μL of 20% (w/v) concentration in normal saline], two set of corneas served as negative control and was treated with 750 μL of normal saline and corn oil,
Duration of treatment / exposure:
4 h ± 5 minutes at 32 ± 1 °C
Duration of post- treatment incubation (in vitro):
4 h ± 5 minutes at 32 ± 1 °C
Number of animals or in vitro replicates:
3 corneas per test group. 12 in total

Results and discussion

In vitro

Results
Irritation parameter:
cornea opacity score
Value:
> -0.05 - < 0.19
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not irritatiing.