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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methoxybutyl acetate
EC Number:
224-644-9
EC Name:
3-methoxybutyl acetate
Cas Number:
4435-53-4
Molecular formula:
C7H14O3
IUPAC Name:
3-methoxybutyl acetate
Constituent 2
Reference substance name:
butoxyl rein 98/100%
IUPAC Name:
butoxyl rein 98/100%
Details on test material:
- Name of test material (as cited in study report): Butoxyl rein 98/100%
- Physical state: Colourless clear fluid
- Analytical purity: 99.7%
- Purity test date: 8 November 1991
- Lot/batch No.: production date 21 August 1991
- Stability under test conditions: 5 years
- Storage condition of test material: darkness at room temperature in fume cupboard

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.9-3.2 kg
- Housing: individually
- Diet: Altromin 2123 ad libitum and approximately 15g hay per day
- Water: ad libitum
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ±3°C
- Humidity: 55±20%
- Air changes (per hr): not reported
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 22 October 1991 To: 25 October 1991

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm 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): warm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

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:
0
Remarks on result:
other: no erythema at any time point
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: no erythema at any time point
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: no erythema at any time point
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: no oedema at any time point
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: no oedema at any time point
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: no oedema at any time point
Other effects:
none

Any other information on results incl. tables

No signs of irritation were observed during the whole observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Butoxyl rein 98/100% is non irritant to skin.
Executive summary:

The skin irritancy potential of butoxyl rein 98/100 was assessed in 3 rabbits according to OECD guideline 404. Rabbits were exposed to 0.5mL of the test substance under a semi-occlusive dressing for 4 hours, after which the patches were removed and the skin decontaminated. The skin reaction was assessed according to the numerical scoring system at approximately 1, 24, 48 and 72 hours after application.

There were no signs of irritation in any rabbit and the mean scores for erythema and oedema were 0.00.

Butoxyl was considered to be not irritating to rabbit skin.