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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
eye 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 405 (Acute Eye 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-(-)-Mandelsaeure
no further data

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Germany
- Weight at study initiation: 2.00-2.14 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

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eyes of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
single application
Observation period (in vivo):
24 hours, study was discontinued due to severe effects on the eyes
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: according to OECD guidelines 405


TOOL USED TO ASSESS SCORE: light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
4
Reversibility:
not fully reversible within: 24 hours
Remarks on result:
other: The study was discontinued after 24 hours because of severe irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hours
Remarks on result:
other: iris score could not be read due to severe corneal opacity
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 2
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours
Score:
2
Reversibility:
not fully reversible within: 24 hours

Any other information on results incl. tables

Due to the severe eye irritation observed, the study was discontinued after 24 hours. The test substance is there for classified as posing the risk of serious eye damage (R41) according to EU- and as eye irritant Cat.1 according to GHS-criteria.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information