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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01-Dec-2008 - 16-Feb-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 405 (Acute Eye 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: 80.54% (iodometric based on mercapto group, calculated for Glyceryl monothioglycolate)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Only females
- Source: Charles River Deutschland, D-88353 Kisslegg
- Age at study initiation: No data
- Weight at study initiation: 4.1, 4.7, 5.1 kg
- Housing: ABS - plastic rabbit cages, floor 4200 cm^2, Semi-barrier in an air conditioned room
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 5 days


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


Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL of unchanged test article
Duration of treatment / exposure:
- single dose application
- not rinsed
Observation period (in vivo):
- animal 1 was observed for 8 days after dosing
- animal 2 and 3 were observed for 7 days after dosing
- for calculation only the 24 h, 48 h and 72 h readings were used
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Fluorescein solution (Fluoreszein SE Thilo®, Lot H 801, expiry date: January 2010)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity 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:
cornea opacity 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:
cornea opacity 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:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
Test item produced irritating effects which were fully reversible in all three animals within 8 days post instillation.
Other effects:
Neither mortalities nor significant clinical signs of toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance GMT (SH content of 80.5%) was considered as slightly irritating when administered by the ocular route in rabbits. GMT (SH content of 80.5%) does not have to be classified according to GHS.