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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
other: Guideline study (1a: GLP Guideline study)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
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

Constituent 1
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
Constituent 2
Reference substance name:
iso-Tridecyl 3-Mercaptopropionate
IUPAC Name:
iso-Tridecyl 3-Mercaptopropionate
Constituent 3
Reference substance name:
iso-Tridecyl 3-Mercaptopropionate
IUPAC Name:
iso-Tridecyl 3-Mercaptopropionate
Constituent 4
Reference substance name:
Reaction mass of isotridecyl 3-mercaptopropionate and isododecyl 3-mercaptopropionate
Cas Number:
1040871-35-9
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.

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:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 h
Score:
4.7
Reversibility:
fully reversible within: >1 to 24 h
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h
Max. score:
6
Reversibility:
fully reversible within: >1 to 24 h
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: at each observation date
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: at each observation date
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Max. score:
6
Reversibility:
fully reversible within: >1 to 24 h
Remarks on result:
other: redness (all 3 animals), chemosis and discharge (only 2 of three test animals) observed
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:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: modified Kay and Calandra classification system
Conclusions:
The test substance is "minimal" (slightly) 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.