Propanoic acid, 3-mercapto-, C11-14-isoalkyl esters, C13-rich

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-11-21 to 1997-12-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

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

Molecular formula:

C16 H32 O2 S

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

EC Number:

929-442-0

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK;
3 animals tested in parallel;
weight at test start: 2.52 to 2.85 kg; age: 12 to 16 weeks

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

14 d

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: on the back of each animal (ca. 2.5 x 2.5 mL)
- % coverage: 100 (with a cotton gauze patch)
- Type of wrap if used: elaticated corset (TUBIGRIP)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in 74% industrial methylated spirits
- Time after start of exposure: 4 h


SCORING SYSTEM: according to: Draize JH (1977), Dermal and Eye Toxicity Tests

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: >7 to 14 d

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: >7 to 14 d

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: >7 to 14 d

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

classification as MILD IRRITANT to rabbit skin according to Draize classification scheme;
no corrosive effects were noted;
The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required.

Other effects:

Very slight erythema was noted at one treated skin site one hour after patch removal and at all treated skin sites at the 24-hour observation. Well-defined erythema was noted at one treated skin site with very slight erythema at two treated skin sites at the 48- and 72 hour observations.

Moderate desquamation was noted at all treated skin sites at the 7-day observation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the test results, ISO-TRIDECYL 3-MERCAPTOPROPIONATE is not irritating to skin

Executive summary:

An in-vivo acute dermal irritation study with rabbit was performed with the test substance ISO-TRIDECYL 3-MERCAPTOPROPIONATE according to OECD guideline 404 and EU method B.4 and in compliance with international GLP

regulations. The test was performed in triplicates and all validity criteria were met.

The test substance, ISO-TRIDECYL 3-MERCAPTOPROPIONATE, produced a primary irritation index of 1.3 and was classified as a MILD IRRITANT to rabbit skin according to Draize classification scheme. No corrosive effects were noted. The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required.