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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
Study period:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

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
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Aspartic acid
EC Number:
200-291-6
EC Name:
Aspartic acid
Cas Number:
56-84-8
Molecular formula:
C4H7NO4
IUPAC Name:
aspartic acid
Constituent 2
Reference substance name:
L-Asparaginsäure
IUPAC Name:
L-Asparaginsäure
Constituent 3
Reference substance name:
S-(+) amino succinic acid
IUPAC Name:
S-(+) amino succinic acid
Test material form:
solid: crystalline
Details on test material:
Supplier: Sponsor.
Batch No.: PRCA 015.
CAS No. 56-84-8.
Appearance: White, crystalline.
Purity: Approx. 99 %.
pH: 2.5 – 3.5 (4 g/L at 20 °C). Determined for a 1 % w/v suspension: 3.03.
Melting range: 265 – 271 °C.
Solubility in water: 5 g/L at 25°C.
Conditions of storage: In the refrigerator, in the dark, may be used under light.
Date of expiry: 31 December 2002.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Supplier: Charles River Wiga, D-97633 Sulzfeld.Hygiene: Optimal hygienic conditions.
Weight: 1.8 to 2.0 kg at the start of the study.
Room temperature: Average of 19.1 °C (continuous control and recording).
Relative humidity: Average of 53.6 % (continuous control and recording).
Air exchange: 12 per hour.
Light: Artificial light from 6 a.m. to 6 p.m.
Cages: Individual caging in metal wire cages, 79 cm x 59 cm bottom area, 38 cm height, with a wooden rest shelf, 15 cm x 59 cm.
Feed Altromin 2023 diet for rabbits, ad libitum. Hay-briquetteswere offered additionally as a dietary supplement.
Water: Tap water from an automatic watering system, ad libitum.
Acclimatisation: 5 days.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
substance was moistened with 1 mL.
Controls:
not required
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
The skins of the animals were examined for local alterations after the clipping procedure (one day before the application) and immediately before the application. The treated areas and the surrounding untreated skin (control area) of the animals were examined for erythema/eschar and oedema as well as for other local alterations approximately 1, 24, 48 and 72 hours after patch removal.
Number of animals:
3 females.

Results and discussion

In vivo

Results
Irritation parameter:
other: erythema as well as edema scores
Basis:
animal: No. 1, 2 and 3
Time point:
other: 1, 24, 48 and 72 hours after patch removal.
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
All areas to be treated with the test substance and all control areas were normal before the application and at each observation time.
Other effects:
No general toxic effects were noted.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
All exposed skin sites were normal at each examination term.
Executive summary:

The possible irritating or corrosive effects of the substance, following a single application to the intact skin of rabbits, was investigated in conformance with the OECD-Guideline 404 and the Directive 92/69/EEC, method B.4.

All exposed skin sites were normal at each examination term.

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