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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
.
Justification for type of information:
see read-acorss justification attached in chapter 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl 4-hydroxybenzoate
EC Number:
204-399-4
EC Name:
Ethyl 4-hydroxybenzoate
Cas Number:
120-47-8
Molecular formula:
C9H10O3
IUPAC Name:
ethyl 4-hydroxybenzoate
Details on test material:
- Name of test material (as cited in study report): Solbrol A
- Physical state: solid
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
other: HC:NWZ
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: 3500 g
- Housing: Animals were housed individually
- Diet: ssniff K, ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Not required, the untreated sites of the same animal served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g test substance, moistened with water
Duration of treatment / exposure:
4 h
Observation period:
7 d
reading time points: 1, 24, 48, 72 h and 7 d
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: approximately 6 cm² on the back of the animal
- Type of wrap if used: The test substance was applied to a gauze patch, held in place by elastic tape that was permeable to air.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated skin sites were washed with water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Dermal application of the test substance did not result in erythema or edema in any of the animals tested at any observation time point.
Other effects:
no data on body weight and clinical observations

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified