Registration Dossier

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:
21/06/2017-21/06/2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Raction product of 2-Ethyl-1-hexylamine and 3-(2-Ethylhexyloxy)propylamine with 4-bromo-1,8 naphthalic anhydride
EC Number:
826-490-3
Cas Number:
1971906-58-7
Molecular formula:
Not applicable (UVCB substance)
IUPAC Name:
Raction product of 2-Ethyl-1-hexylamine and 3-(2-Ethylhexyloxy)propylamine with 4-bromo-1,8 naphthalic anhydride
Test material form:
liquid: viscous

Test animals / tissue source

Species:
other: Bovine
Strain:
not specified

Test system

Vehicle:
physiological saline
Amount / concentration applied:
TEST MATERIAL
It was not possible to get a 20% concentration of solution/suspension with the test item in physiological saline 0.9% NaCl. Therefore the test item was administered directly and moistened with physiological saline 0.9% NaCl.

VEHICLE
Physiological saline 0.9% NaCl (AlleMan Pharma, lot no. 609709, expiry date: 21/06/2017)
Number of animals or in vitro replicates:
3

Results and discussion

In vitro

Results
Irritation parameter:
cornea opacity score
Value:
13.09
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
No prediction can be made regarding the classification of the test substance YELLOW 2747 according to the evaluation criteria. Further testing in another suitable method is required.