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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17-Mar-2009 - 16-Apr-2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Landesinstitut für Arbeitsschutz und Produktsicherheit

Test material

Constituent 1
Chemical structure
Reference substance name:
Mercaptoacetic acid, monoester with propane-1,2,3-triol
EC Number:
250-264-8
EC Name:
Mercaptoacetic acid, monoester with propane-1,2,3-triol
Cas Number:
30618-84-9
Molecular formula:
C5H10O4S
IUPAC Name:
2,3-dihydroxypropyl 2-sulfanylacetate
Test material form:
solid - liquid: suspension
Details on test material:
- Name of test material (as cited in study report): Glyceryl Thioglycolate 80 %
- Analytical purity: 80.8 % (iodometric, based on mercaptogroup, calculated for Glycerylmonothioglycolate)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, D-97633 Sulzfeld
- Sex: 3 females
- Age at study initiation: no data
- Weight at study initiation: > 2 kg
- Housing: Semi-barrier in an air-conditioned room
- Diet: Ad libitum
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 X / h
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.5 mL per test site
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 females rabbits
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: The test item was applied first to a gauze patch at a single dose. The patch was then applied to the skin on a small area on the left side of the dorsal area. The gauze was held in place with non-irritating tape. The untreated right side served as control. The patch was fixed with a semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Tap water
- Time after start of exposure: 4 h


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test item showed neither irritant nor corrosive effects on the intact skin of 3 female rabbits after a contact time of 4 hours.
Other effects:
Neither mortalities nor significant clinical signs of toxicity were observed.
There were no significant bodyweight changes during the contact and observation period .

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Single application of 0.5 mL of GMT to 3 female rabbits showed neither irritating nor corrosive effects. According to GHS GMT has not to be classified.