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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
L-2-hydroxy-2-phenylacetic acid
EC Number:
210-276-6
EC Name:
L-2-hydroxy-2-phenylacetic acid
Cas Number:
611-71-2
Molecular formula:
C8H8O3
IUPAC Name:
hydroxy(phenyl)acetic acid
Details on test material:
- Name of test material (as cited in study report): D-(-)-Mandelsaure, technisch rein
no further data

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Germany
- Weight at study initiation: 2.65-279 kg
- Housing: individually
- Diet: ca. 130 g/animal/day
- Water: ca. 250 ml/animal/day
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: untreated skin of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 80 % aqueous formulation (w/w)


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g of the suspension
- Concentration (if solution): 80 % aqueous formulation (w/w)
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: upper third of the back or flanks
- % coverage: 2.5 xm x 2.5 cm
- Type of wrap if used: test patches were secured in position with a porous dressing (four layers of absorbent gauze and porous bandage)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Remarks on result:
other: no signs of erythema were observed at any time
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Remarks on result:
other: no signs of edema were observed at any time

Any other information on results incl. tables

As no signs of irritation were observed, there is no need for classification of the test substance according to EU- and GHS-criteria. The test substance is not irritating to the skin.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS