Registration Dossier
Registration Dossier
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EC number: 241-503-7 | CAS number: 17496-08-1
Eye irritation
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- 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 i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ammonium propionate
- EC Number:
- 241-503-7
- EC Name:
- Ammonium propionate
- Cas Number:
- 17496-08-1
- Molecular formula:
- C3H6O2.H3N
- IUPAC Name:
- ammonium propionate
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- Species
Bos primigenius Taurus (fresh bovine corneas)
Origin
Fresh bovine eyes were obtained from the slaughterhouse NAVA GROUP SpA, Strada Provinciale 121, Agrate Brianza, on the day of the test. The cattle were between 12 and 60 months old.
The eyes were removed as soon as possible after death of the cattle and immersed in Hanks’ Balanced Salt Solution (addicting antibiotic as Penicillin-Streptomycin) in a suitable and cool container. The eyes were transported to the test facility within 4 h where they are used at once.
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Duration of treatment / exposure:
- The holder with the treated corneas were incubated for the exposure time of 10 minutes in incubator at 32 ± 1°C.
- Duration of post- treatment incubation (in vitro):
- 120 minutes
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- ca. 133.99
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the conditions of this test, the test item “Ammonium propionate (CAS: 17496-08-1; EC: 241-503-7) in aqueous solution (50-55 %)” showed effects on the cornea of the bovine eye.
The calculated IVIS (in vitro irritancy score) is 133.99.
The negative control (NaCl 0.9 %) and the positive control (Ethanol) have met the validity criteria.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS > 55 induces serious eye damage are classified as UN GHS Category 1.
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