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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: Guideline study (OECD)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
[(butoxymethylethoxy)methylethoxy]propan-1-ol
EC Number:
259-910-3
EC Name:
[(butoxymethylethoxy)methylethoxy]propan-1-ol
Cas Number:
55934-93-5
Molecular formula:
C13H28O4
IUPAC Name:
[(butoxymethylethoxy)methylethoxy]propan-1-ol
Details on test material:
- Name of test material (as cited in study report): Solvenon TPNB Test substance no. 01/0022-1
- Physical state: liquid clourless clear
- Analytical purity: report no. 01L00014
- Purity test date: Apr 14, 2000
- Stability under test conditions: guaranteed for the duration of the study
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen, Germany
- Age at study initiation: about 7 months
- Weight at study initiation: 3.20-3.39 kg
- Fasting period before study: none
- Housing: singel housing in stainless steel wire mesh cages with gating
- Diet: Kliba-Laboratory diet, Provima Kliba SA, Kaiseraugst, Swiss ad libitum
- 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 hrs

Test system

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Controls:
other:
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: upper third of the back or flanks
- Type of wrap if used: semiocclusive dressing


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


SCORING SYSTEM:
Erythema and Eschar Formation:
0 = No erythema
1 = Very slight erythema (barely perceptible)
2 = Well defined erythema
3 = Moderate to severe erythema
4 = Severe erythema (beet-redness) to slight, eschar formation (injuries in depth)

Edema Formation:
0 = No edema
1 = Very slight edema (barely perceptible)
2 = Slight edema (edges of area well defined by definite raising)
3 = Moderate edema (raised approx. 1 mm)
4 = Severe edema (raised more than 1 mm and extending beyond the area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(animal 1-3)
Time point:
other: 24 - 48 - 72 h
Score:
1.6
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: see table below for details
Irritation parameter:
edema score
Basis:
mean
Remarks:
(animal 1-3)
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Other effects:
Slight to moderate erythema, in 1 animal extending beyond the area of exposure, was observed in all animals during the course of the study. No edema was noted. The cutaneous reactions were reversible in all animals within 8 days after removal of the patch at latest. The average score (24 to 72 hours) for irritation was calculated to be 1.6 for erythema and 0.0 for edema.

Any other information on results incl. tables

Readings

Animal

Exposure period: 4 h

Erythema

Edema

Additional findings

1 h

1

1

0

2

2

0

3

2

0

24 h

1

2

0

15

2

2

0

3

2

0

48 h

1

2

0

15

2

2

0

3

1

0

72 h

1

1

0

2

2

0

3

0

0

SD

8 d

1

0

0

2

0

0

Mean

24h, 48h, 72 h

1

1.7

0

2

2.0

0

3

1.0

0

Mean

1.6

0

Symbols:

15  = Erytema extending beyond the area of exposure

SD = Study discontinued because the animal was free of symptomes

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU