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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

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
adopted 1992
GLP compliance:
yes
Remarks:
(BASF AG, Dep. of Toxicology)

Test material

Constituent 1
Chemical structure
Reference substance name:
Butyl vinyl ether
EC Number:
203-860-7
EC Name:
Butyl vinyl ether
Cas Number:
111-34-2
Molecular formula:
C6H12O
IUPAC Name:
1-(ethenyloxy)butane

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. Thomae GmbH (FRG)
- Age at study initiation: young adult, no further data
- weight at study initiation: 3.73 (male), 3.98 (female), and 3.99 (females) kg
- Housing: singly
- certified diet and tap water ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin
Amount / concentration applied:
0.5 mL undiluted TS
Duration of treatment / exposure:
4 hour(s)
Observation period:
1, 24, 48, and 72 hours and 8 & 15 days after removal of the patches
Number of animals:
3
Details on study design:
The fur was clipped at least 24 hrs before treatment.
Application: A pad (2.5 cm x 2.5 cm) soaked with 0.5 mL of undiluted TS was placed to the shaved, intact rabbit's dorsal skin (secured by semi-occlusive dressing). At the end of the contact period excess test substance was washed off.
Observations, examinations: Skin reactions were examined 1, 24, 48, and 72 hours and 8 & 15 days after removal of the patches
Data evaluation: Skin reactions were scored according to the table of Draize contained in the OECD TG 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 15 d
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 15 d
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 15 d
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 8 days
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 15 d
Remarks on result:
other: scaling in 2 rabbits
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 15 days
Score:
0.3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: scaling in 3/3 rabbits, erythema score 1 in one rabbit (other score 0)
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, or 48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
The effects extended beyond the area of exposure.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The undiluted test substance was irritating to the rabbit skin.
Executive summary:

Guideline study

Three New Zealand White rabbits received dermal application 0.5 mL undiluted BVE to the shaved skin under semi-occlusive dressing for 4 h (washing at termination). Scoring was performed 1, 24, 48, and 72 hours and 8 & 15 days after removal of the patches. The mean score for erythema was 3.0, 2.7, and 2.7 24, 48, and 72 h after patch removal, respectively. Erythema was not reversible in one rabbit at termination and all three rabbits showed scaling of the skin (day 15). Edema reached only score 1 24 -72 h after patch removal and was reversible within 8 days.

Conclusion: The undiluted test substance was irritating to the rabbit skin.