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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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 OD5401

Mean % Viability1

Negative control
distilled water

3 minute

1.977

100%

60 minute

1.986

100%

Positive Control
Material

3 minute

0.109

5.512

60 minute

0.100

5.043

Test Material

3 minute

0.104

5.262

60 minute

0.104

5.243

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.