Registration Dossier
Registration Dossier
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EC number: 256-589-1 | CAS number: 50448-95-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-12-01 to 1997-12-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of iso-tridecyl 3-mercaptopropionate and iso-dodecyl 3-mercaptopropionate
- IUPAC Name:
- Reaction mass of iso-tridecyl 3-mercaptopropionate and iso-dodecyl 3-mercaptopropionate
- Reference substance name:
- iso-Tridecyl 3-Mercaptopropionate
- Molecular formula:
- C16 H32 O2 S
- IUPAC Name:
- iso-Tridecyl 3-Mercaptopropionate
- Reference substance name:
- iso-Tridecyl 3-Mercaptopropionate
- IUPAC Name:
- iso-Tridecyl 3-Mercaptopropionate
- Reference substance name:
- Reaction mass of isotridecyl 3-mercaptopropionate and isododecyl 3-mercaptopropionate
- EC Number:
- 929-442-0
- IUPAC Name:
- Reaction mass of isotridecyl 3-mercaptopropionate and isododecyl 3-mercaptopropionate
- Details on test material:
- batch no. B97E2009;
colourless liquid;
storage at room temperature
comment: test substance used in this study
The study was performed with a test material identical to the submission substance (identical producer and identical way of synthesis). In the test report the test item is named iso-tridecyl-3-mercaptopropionate, which is used as the chemical name and as the trade name by the producer.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK;
3 animals tested in parallel;
weight at teststart: 2.31 to 2.71 kg; age: 12 to 16 weeks
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- no active removal of the applied test substance by laboratory staff reported
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: not done
SCORING SYSTEM: according to: Draize JH (1977), Dermal and Eye Toxicity Tests
TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No corneal or iridial effects were noted during the study. Minimal conjunctival irritation was noted in all treated eyes one hour after treatment. Treated eyes appeared normal at the 24-hour observation.
- Other effects:
- no further effects observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not irritant to the rabbit eye.
- Executive summary:
An in-vivo acute eye irritation study in the rabbit was performed with the test substance ISO-TRIDECYL 3 -MERCAPTOPROPIONATE according to OECD guideline 405 and EU method B5 and compliance with the international GLP regulations. All validity criteria were met.
The test substance produced a maximum group mean score of 4.7 and was classified as a MIMIMAL IRRITANT (CLASS 3 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified Kay and Calandra classification system.
The test substance did not produce positive criteria in any rabbit according to the EU labelling regulations. No symbol and risk phrase are therefore required.
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