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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Method followed similar to a recognised guideline; performed under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrahydro-4-methyl-2-phenyl-2H-pyran
EC Number:
303-662-1
EC Name:
Tetrahydro-4-methyl-2-phenyl-2H-pyran
Cas Number:
94201-73-7
Molecular formula:
C12H16O
IUPAC Name:
4-methyl-2-phenyloxane
Test material form:
other: liquid
Details on test material:
- Physical state: liquid
- Storage condition of test material: stored in the dark at about 4°C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: reognised animal source
- Age at study initiation: not reported
- Weight at study initiation: 2.3 - 2.5 kg
- Housing: individually housed in grid-bottomed metal cages.
- Diet (e.g. ad libitum): certified pelleted diet ad libitum
- Water (e.g. ad libitum): mains water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21
- Humidity (%): 39 - 65
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5ml test material applied to clipped backs of test animals.
Duration of treatment / exposure:
4 hours
Observation period:
skin reaction to the test article was assessed after one, 24, 48 and 72 hours. Additional assessments were carried out 7 and 14 days after dosing.
Number of animals:
4 females
Details on study design:
TEST SITE
- Area of exposure: doral surface of the trunk
- % coverage: not reported
- Type of wrap if used: Elastoplast elastic adhesive bandage 7.5cm wide.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes - test substance application site cleansed using cotton wool soaked in warm water
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hour
Score:
0.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hour
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hour
Score:
2.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hour
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 7 days
Score:
2.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 14 days
Score:
1.25
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hour
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hour
Score:
2.5
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hour
Score:
3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hour
Score:
3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 7 days
Score:
2.75
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 14 days
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
One hour after dosing all animals exhibited slight oedema (grade 2) and most exhibited very slight erythema (grade 1). By 24 hours all animals exhibited well-defined erythema (grade 2) and slight to moderate oedema (grades 2-3). Responses increased until at the 72 hour examination all animals exhibited moderate to severe erythema and moderate oedema (grade 3). Seven days after dosing most animals were noted to have the same degree of irritation, except one animal, which exhibited grade 2 erythema and oedema. At this examination all animals were also noted to have desquamation. Fourteen days after dosing all the animals still exhibited very slight to well-defined erythema (grades 1-2) and one animal had desquamation and skin thickening but no oedema was observed on any animal.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study the test substance is considered to be irritating to skin.
Executive summary:

The study was performed to assess the irritancy potential of the test substance to the skin of the New Zealand White rabbit. The study was performed to GLP and followed a method similar to the EU Method B.4. The test substance was applied over an area of approximately 2.5cm square to the clipped backs of 4 albino rabbits. The test substance was held in contact with the skin under a semi-occlusive patch for a 4 hour period. After this time the patches were removed and the skin reaction to the test substance was assessed after one, 24, 48 and 72 hours. Additional assessments were carried out 7 and 14 days after dosing to determine the degree of reversibility of the skin reaction. One hour after dosing all animals exhibited slight oedema (grade 2) and most exhibited very slight erythema (grade 1). By 24 hours all animals exhibited well-defined erythema (grade 2) and slight to moderate oedema (grades 2-3). Responses increased until at the 72 hour examination all animals exhibited moderate to severe erythema and moderate oedema (grade 3). Seven days after dosing most animals were noted to have the same degree of irritation, except one animal, which exhibited grade 2 erythema and oedema. At this examination all animals were also noted to have desquamation. Fourteen days after dosing all the animals still exhibited very slight to well-defined erythema (grades 1-2) and one animal had desquamation and skin thickening but no oedema was observed on any animal. The calculated mean score for erythema or eschar formation was 2.6. The calculated mean score for oedema was 2.8. It was concluded that the test material is irritating to the skin of the albino rabbit.