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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-aminothiazol-4-acetic acid
EC Number:
249-769-6
EC Name:
2-aminothiazol-4-acetic acid
Cas Number:
29676-71-9
Molecular formula:
C5H6N2O2S
IUPAC Name:
(2-amino-1,3-thiazol-4-yl)acetic acid
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
Crl: KBL (NZW)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany,
- Age at study initiation: Approximately 22 weeks old
- Weight at study initiation: > 2 Kg
- Housing: Semi-barrier in an air conditioned room. Housed in ABS plastic rabbit cages.
- Diet (e.g. ad libitum): Free access to autoclaved hay and Altromin maintenance diet for rabbits.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): At least 10
- Photoperiod (hrs dark / hrs light): Artificial light (12 hours light/dark cycle)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
Aqua ad injectionem
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test item was applied.

VEHICLE
- Amount(s) applied (volume or weight with unit): Only used to ensure good contact with the test substance and skin.



Duration of treatment / exposure:
Applied over a 4 hour period
Observation period:
Up to 72 hours after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Left side of dorsal area
- % coverage: approximately 6 cm3
- Type of wrap if used: the gauze used was held in place with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with tap water after 4 hours of exposure

OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 1, 24, 48 and 72 hours after patch removal.

SCORING SYSTEM:
- Method of calculation: Scoring and grading as per standard system in relevant OECD guideline.

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
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
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
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
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
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
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
In the initial animal, erythema grade 1 was observed immediately after patch removal and 1 hour after. The same effects were noted in animal 2 with no signs observed in animal number 3. No other signs of irritation were observed and the initial effects observed at 1 hour in the first two animals were completely reversible by the 24 hour observation point.
Other effects:
There were no significant bodyweight changes, clinical signs and no mortality observed in any animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study, the dermal application of the test substance showed no irritant or corrosive effects.