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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14.08.2018 - 19.10.2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
Version / remarks:
Adopted June 25, 2018
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C12-18 and C18-unsatd., reaction products with chloroacetic acid and 2-(dimethylamino)ethanol and N,N-dimethyl-1,3-propanediamine
EC Number:
295-171-3
EC Name:
Fatty acids, C12-18 and C18-unsatd., reaction products with chloroacetic acid and 2-(dimethylamino)ethanol and N,N-dimethyl-1,3-propanediamine
Cas Number:
91845-01-1
Molecular formula:
C24H48NO4, C25H51N2O3
IUPAC Name:
2-(dimethylamino)ethyl hexadecanoate; 2-(dimethylamino)ethyl octadecanoate; N-[3-(dimethylamino)propyl]hexadecanamide; N-[3-(dimethylamino)propyl]octadecanamide
Test material form:
solid: bulk

Test animals / tissue source

Species:
cattle
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, -'s Hertogenbosch, The Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter. Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.

Test system

Vehicle:
other: cMEM, Earle’s Minimum Essential Medium
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
310.4 to 336.7 mg
Duration of treatment / exposure:
240 +/- 10 min.
Number of animals or in vitro replicates:
3
Details on study design:
The test consists of topical application of 03590 on the epithelium of the bovine cornea for 4 hours. The non-surfactant solid test item is applied neat by direct application to the surface of the cornea. After exposure the corneas were thoroughly rinsed. The opacity of the corneas was determined directly after treatment and the permeability of the corneas was determined after a 90 minutes incubation period with sodium fluorescein.
The design of this study is based on the following study 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, (adopted October 09, 2017).

Results and discussion

In vitro

Results
Irritation parameter:
cornea opacity score
Run / experiment:
3
Value:
>= 20 - <= 25
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, since 03590 induced an IVIS > 3 ≤ 55, no prediction on the classification can be made.