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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
May 12, 1981
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-[(2-aminoethyl)amino]propane-1-sulfonic acid
Cas Number:
14235-54-2
Molecular formula:
C5H14N2O3S
IUPAC Name:
3-[(2-aminoethyl)amino]propane-1-sulfonic acid
Details on test material:
- Name of test material (as cited in study report): EPS
- Physical state: viscous
- Analytical purity: abt. 99 % (as specified by the sponsor)
- Lot/batch No.: LA 92018 SC
- Storage condition of test material: ambient

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever; Kaninchenfarm, 2740 Bremervörde, Neuendamm 88, Germany
- Housing: individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
- Diet: ad libitum, Ssniff K - Haltung
- Water: ad libitum, drinking water as for human consumption

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3° C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): artificial lightings (120 lux) from 7.00 a.m. - 7.00 p.m.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: hair clipped
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 of the test article / 6 cm2
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 hours
Observation period:
30-60 minutes, 24, 48, 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: ca. 6 cm2
- Type of wrap if used: Ypsiplast, which was held in place by non-irritating tape Elastoplast and Stülpa, envelopping the whole of the animal's trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water or an appropriate solvent
- Time after start of exposure: 4 hours


SCORING SYSTEM:
Erythema and Eschar Formation
No erythema .......................................................................................................................................................0
Very slight erythema (barely perceptible) ......................................................................................................1
Well defined erythema .......................................................................................................................................2
Moderate to severe erythema ..........................................................................................................................3
Severe erythema (beef redness) to eschar formation preventing grading of erythema.........................4
Maximum possible: 4

Oedema Formation
No oedema......................................................................................................................................................0
Very slight oedema (barely perceptible) ...................................................................................................1
Slight oedema (edges of area well defined by definite raising) .............................................................2
Moderate oedema (raised approximately 1 mm) .....................................................................................3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) .........................4
Maximum possible: 4

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 h after patch removal
Score:
ca. 0
Max. score:
0
Reversibility:
other: not relevant
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EEC directive 91/325/EEC of March 1,1991
Executive summary:

The potential of "EPS" was assessed in an acute dermal irritation/corrosion test on 3 albino rabbits. The skin was exposed to the test article for 4 h. Animals were examnied for signes of erythema and oedema at 30 -60 min, 24, 48, 72 h after patch removal.

The mean grades of skin reactions after 24, 48 and 72 h after patch removal were lower than the value classified as irritant by the EEC directive 91/325 EEC of March 1, 1991 and the Gefahrenstoffverordnung (GefStoffV), 1987 (BGBl. I, p. 2721). When applied to the skin, the test article "EPS" may therefore be considered to be non-irritant.