3-mercaptopropionic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18-19 July 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study; GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-mercaptopropionic acid

EC Number:

203-537-0

EC Name:

3-mercaptopropionic acid

Cas Number:

107-96-0

Molecular formula:

C3H6O2S

IUPAC Name:

3-sulfanylpropanoic acid

Details on test material:

- Name of test material (as cited in study report): 3-mercaptopropionic acid
- Physical state: clear colourless liquid
- Analytical purity: 99.8% (GC)
- Purity test date: 2002-03-27
- Lot/batch No.: 1672
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: room temperature in the dark

Test animals

Species:

other: human in vitro

Details on test animals or test system and environmental conditions:

EpiDerm Skin Model (MatTek, Ashland, MA, USA)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

50 µL, undiluted

Duration of treatment / exposure:

3 min, 60 min

Observation period:

3 h

Number of animals:

duplicate tissues were used per exposure time

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period each EpiDerm tissue was rinsed using Dulbecco’s phosphate buffered saline (DPBS).
- Time after start of exposure: 3 min, 60 min


SCORING SYSTEM: Data are presented in the form of % viability (MTT conversion relative to negative controls) for each of the two exposure times.
Classification of corrosivity potential was based on relative viabilities for both exposure times according to the Table 1 (Material & Methods).

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

after 60 min exposure

Value:

5.24

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

after 3 min exposure

Value:

5.26

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

see table 2 under "Any other information on results"

Any other information on results incl. tables

The relative mean viability was 5.26% after 3 minutes exposure, and 5.24% after 60 minutes exposure. The relative mean viability of the test material-treated tissues was <10% after 3 minutes exposure.

Table 2: Mean OD₅₄₀Values and Mean % Viabilities for the Negative Control, Positive Control Material and Test Material

Material	Exposure Time	Mean OD540^1	Mean % Viability^1
Negative control distilled water	3 minute	1.977	100%
	60 minute	1.986	100%
Positive Control Material	3 minute	0.109	5.51^2
	60 minute	0.100	5.04^3
Test Material	3 minute	0.104	5.26^2
	60 minute	0.104	5.24^3

¹= Mean of 2 EpiDerm tissues tested in duplicate

²= Mean viability expressed as a percentage of the mean viability of the 3 minute negative control tissues

³= Mean viability expressed as a percentage of the mean viability of the 60 minute negative control tissues

Applicant's summary and conclusion

Interpretation of results:

highly corrosive

Remarks:

Migrated information C, R35 Criteria used for interpretation of results: EU

Conclusions:

The test material is considered to have the potential to be corrosive in-vivo.
The symbol “C” and the highest risk phrase R35 “Causes severe burns” are required.