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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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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:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(4-hydroxybenzoyloxy)-3-methylphenyl 4-hydroxybenzoate
EC Number:
601-643-5
Cas Number:
119959-84-1
Molecular formula:
C21H16O6
IUPAC Name:
4-(4-hydroxybenzoyloxy)-3-methylphenyl 4-hydroxybenzoate
Details on test material:
- Name of test material (as cited in study report): Bis-1,4-(p-Hydroxybenzoesaeure)-methylphenylendiester
- Physical state: solid
- Storage condition of test material: room temperature
- Analytical purity: 99.6% (HPLC)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: Young adult animals
- Weight at study initiation: 3.8 - 4.0 kg
- Housing: Single housing in stainless steel wire mesh cages with grating
- Diet: Kliba-Labordiaet, Provimi Kuba SA, Kaiseraugst, Switzerland ad libitum
- Water: Tap water ad libitum.
- Acclimation period: at least 1 week before study start

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
moistened with water
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the unchanged solid test substance (moistened with aqua bidest.; because of the natural moisture of the skin, distilled water was used so that the test has been carried out under as physiological conditions as possible).
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; application area: 2.5 x 2.5 cm
- Type of wrap if used: The test substance has been covered with a test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull(R) stretoh (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end application period with Lutrol and Lutrol/water (1:1).
- Time after start of exposure: 4h

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 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No skin findings were noted in all animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Considering the described cutaneous reactions as well as the average score for irritation, the test substance does not give indication of an irritant property to the skin under the test conditions chosen.
Executive summary:

The potential of the test substance to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 g of the test substance to the intact skin of 3 White New Zealand rabbits for 4 hours under semiocclusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed approximately 1, 24, 48 and 72 hours after

removal of the patch. No skin findings were noted in all animals; thus the study was terminated after 72 hours. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for erythema and for edema. Considering the described cutaneous reactions as well as the average score for irritation, the test substance does not give indication of an irritant property to the skin under the test conditions chosen.