Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2013-01-11 to 2013-03-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 2002
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium (S)-2-hydroxypropionate
EC Number:
248-953-3
EC Name:
Calcium (S)-2-hydroxypropionate
Cas Number:
28305-25-1
Molecular formula:
C3H6O3.1/2Ca
IUPAC Name:
calcium (S)-2-hydroxypropionate
Specific details on test material used for the study:
- Name of test material (as cited in study report): Puracal PP/USP
- Lot/batch No.: 1107003133
- Appearance: white crystalline powder
- Purity: 99.9%
- Expiry date: 29 July 2016
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: S&K-LAP Kft, 2173 Kartal, Csazar ut 135, Hungary
- Age at study initiation: ca. 13 weeks old
- Weight at study initiation: 3125-3459 g
- Housing: animals were individually housed in AAALAC approved metal wire rabbit cages.
- Diet (e.g. ad libitum): animals received UNI diet for rabbits ad libitum (produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi ut, Hungary)
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 25-54
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped and shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g



Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 60 minutes, 24, 48 and 72 hours after patch removal

SCORING SYSTEM:
- Method of calculation: according to Draize, 1959.

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:
At 1, 24, 48 and 72 hours after patch removal, there were no observed clinical signs noted on the skin of the treated animals. As no signs were recorded, the atudy was terminated after 72 hours.
Other effects:
- Other adverse local effects: none
- Other adverse systemic effects: no effects on body weight and no mortality and no adverse clinical signs of toxicity were noted.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
In conclusion, in the acute dermal irritation/corrosion study conducted according to OECD 404, the test item calcium (S)-lactate is considered to be non-irritating.
Executive summary:

In a primary dermal irritation study conducted according to OECD Guideline 404, male young adult New Zealand White albino rabbits (n= 3) were dermally exposed to 0.5 g of calcium (S)-lactate (purity 99.9%) for 4 hours. Animals then were observed 1, 24, 48 and 72 hours after exposure. Irritation was scored by the method of Draize.

In this study, calcium (S)-lactate did not cause any skin effects. Thus, under the conditions of this study, the test substance can be considered as non-irritating.