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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
1996-11-12 until 1997-02-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study followed OECD Guideline under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner)
IUPAC Name:
Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner)
Details on test material:
- Name of test material (as cited in study report): Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner)
- Physical state: solid
- Analytical purity: >95%
- Storage condition of test material: in original container, at room temperature, in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Weight at study initiation: 1.3- 1.8 kg
- Age: Approx. 8 weeks
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 50 % rel. humidity
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12hdark, 12 h light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untrated eye served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 59.1 +/-3 mg
Duration of treatment / exposure:
no substance removal
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: as laid down in OECD Guideline 405


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24-72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24-72h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
see table
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance has not to be classified as irritant according to the EU regulations.
Executive summary:

An eye irritation study according to OECD Guideline 404 under GLP was conducted with Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner) on three New Zealand White Rabbits by administering 59 mg of the substance. The mean scores of the 24, 48 and 72 hour readings did not exceed the limit values according to Directive 93/21 EEC in any case.