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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Experimental Toxicology and Ecology, BASF AG, Ludwigshafen, Germany

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrahydro-4-methyl-2-(2-methylprop-1-enyl)pyran
EC Number:
240-457-5
EC Name:
Tetrahydro-4-methyl-2-(2-methylprop-1-enyl)pyran
Cas Number:
16409-43-1
Molecular formula:
C10H18O
IUPAC Name:
tetrahydro-4-methyl-2-(2-methylprop-1-enyl)pyran

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Centre Lago S. A., 01540 Vonnas, France
- Age at study initiation: 6 - 7 months
- Weight at study initiation: 3.62 - 4.16 kg
- Housing: single
- Diet: Kliba-Labordiaet about 130 g/animal per day
- Water: tap water ad libitum
- Acclimation period: at least 5 days

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping of fur
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48, 72 hours and on day 7, day 14
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: patch of 2.5 cm x 2.5 cm moisted with 0.5 ml undiluted test substance
- Type of wrap if used: The test substance was covered with a test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull® stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 h

SCORING SYSTEM: according to guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
3.1
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7d (2 animals); 14d (1 animal)

Any other information on results incl. tables

Individual cutaneous examination and mean values:

 

 

Exposure period: 4h

Animal

Erythema

Edema

Additional findings

0h

01

2

2

15, 16

02

2

2

15, 16

03

2

2

15, 16

1h

01

3

2

15, 16

02

3

2

15, 16

03

3

2

15, 16

24h

01

3

1

15, 16

02

3

1

15, 16

03

3

1

15, 16

48h

01

3

1

15, 16, 24

02

3

1

15, 16, 24

03

3

1

15, 16, 24

72h

01

3

1

15, 16, 24

02

3

1

15, 16, 24

03

4

1

15, 16, 24

7d

01

2

0

SS, 15, 18

02

3

1

SS, 15, 16, 18, 24

03

3

0

SS, 15, 18, 24

14d

01

2

0

S, 15, 24

02

1

0

S, 15

03

2

0

15

Mean

24-72h

01

3.0

1.0

 

02

3.0

1.0

 

03

3.3

1.0

 

Mean

 

3.1

1.0

 

15 = erythema extending beyond the area of exposure

16 = edema extending beyond the area of exposure

18 = severe scaling extending beyond the area of exposure

24 = petechiae

S = scaling

SS = severe scaling

Applicant's summary and conclusion