Registration Dossier

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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methoxybutan-1-ol
EC Number:
219-741-8
EC Name:
3-methoxybutan-1-ol
Cas Number:
2517-43-3
Molecular formula:
C5H12O2
IUPAC Name:
3-methoxybutan-1-ol
Constituent 2
Reference substance name:
methoxybutanol
IUPAC Name:
methoxybutanol
Details on test material:
- Name of test material (as cited in study report): methoxybutanol
- Physical state: clear, colourless liquid
- Analytical purity: 99.5%
- Lot/batch No.: Hoe CG 0388 0A ZD00 0001
- Expiration date of the lot/batch: August 1996
- pH in water: 7
- Storage condition of test material: in the dark at room temperature in a fume cupbaord

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF Zucht
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.3-3.8 kg
- Fasting period before study: no
- Housing: Individually
- Diet: Altromin 2123 ad libitum and approximately 15 g hay/day
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature: 18±3°C
- Humidity: 55±20%
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light):

IN-LIFE DATES: From: 15-18 October 1991

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hrs
Observation period:
3 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: 2.5 cm x 2.5 cm cellulose patch on a piece of surgical plaster, which was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes; with lukewarm water
- Time after start of exposure: 4 hrs

SCORING SYSTEM: According to OECD guidelines

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 30-60 min
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24h
Remarks on result:
other: Slight erythema (2 on 0-4 scale) present 30-60 mins after end of application. No longer present at the 24 hour reading
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 30-60 min
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24h
Remarks on result:
other: Slight erythema (2 on 0-4 scale) present at 30-60 min after end of treatment
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 30-60 min
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24h
Remarks on result:
other: Very slight erythema (1 on a 0-4 scale) present 30-60 minutes after end of treatment
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: No edema observed at any time point
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 30-60 min
Score:
0
Max. score:
0
Reversibility:
other: No edema observed at any time point
Remarks on result:
other: No edema (0 on 0-4 scale) present at 30-60 min and beyond after end of treatment
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: No edema observed at any time point
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 30-60 min
Score:
0
Max. score:
0
Reversibility:
other: No edema observed at any time point
Remarks on result:
other: No edema (0 on 0-4 scale) present at 30-60 min and beyond after end of treatment
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: No edema observed at any time point
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 30-60 min
Score:
0
Max. score:
0
Reversibility:
other: No edema observed at any time point
Remarks on result:
other: No edema (0 on 0-4 scale) present at 30-60 min and beyond after end of treatment
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No erythema or oedema at 24, 48 or 72 hrs. Methoxybutanol is not a skin irritant.
Executive summary:

No erythema or oedema at 24, 48 or 72 hrs. Methoxybutanol is not a skin irritant.