Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2019
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
catena-[(μ-glycine)-diaqua-sulfato-zinc(II)]
EC Number:
805-657-4
Cas Number:
7214-08-6
Molecular formula:
(Zn(SO4)(C2H5NO2) · 2H2O
IUPAC Name:
catena-[(μ-glycine)-diaqua-sulfato-zinc(II)]
Test material form:
solid

Results and discussion

In vitro

Results
Irritation parameter:
percent corneal swelling
Value:
8
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:
According to the guideline OECD 438, ZINC GLYCINATE overall in vitro classification is neither UN GHS Classification Category I (an ocular corrosive or severe eye irritant) nor No Category. Thus, according to the guideline OECD 438, test item has been categorized as “No prediction can be made”.