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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: GLP compliant, guideline study, no restrictions, fully adequate for assessment,

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
tributene
IUPAC Name:
tributene
Constituent 2
Reference substance name:
C12-monoolefin, mixture of isomers
IUPAC Name:
C12-monoolefin, mixture of isomers
Constituent 3
Chemical structure
Reference substance name:
Trimebutine
EC Number:
254-309-2
EC Name:
Trimebutine
Cas Number:
39133-31-8
Molecular formula:
C22H29NO5
IUPAC Name:
2-(dimethylamino)-2-phenylbutyl 3,4,5-trimethoxybenzoate
Details on test material:
- Name of test material (as cited in study report): Tributene, C12-monoolefin, mixture of isomers
- Physical state: Colourless liquid
- Analytical purity: About 99%

Test animals

Species:
rabbit
Strain:
other: Small white Russian, Chbb-SPF
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr Karl Thomas GmbH, Biberach
- Age at study initiation: Not reported
- Weight at study initiation: 2.1-2.2 kg
- Housing: Individually in stainless steel cages
- Diet: K4 complete feed for rabbits (Ssniff Spezialfutter GmbH, D-4770 Soest) ad libitum
- Water: Tap water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20±1°C
- Humidity: 60±5%
- Air changes: 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light):

IN-LIFE DATES: From: 17 September 1986 To: 01 October 1986

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 cm3
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: mull patch (2.5 x 2.5 cm) covered with polyethylene film (6 x 6 cm), held with an elastic dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: According to OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Irritation index
Basis:
mean
Remarks:
according to VCI notes German Chemical Industry's Association safety data sheet
Time point:
other: 1,24,48,72 hours
Score:
5.92
Remarks on result:
other: 5.92/8.0
Irritation parameter:
erythema score
Basis:
mean
Remarks:
according to Appendix VI of 6th amendment (79/831/EEC)
Time point:
other: Not specified
Score:
3.33
Irritation parameter:
edema score
Basis:
mean
Remarks:
according to Appendix VI of 6th amendment (79/831/EEC)
Time point:
other: Not specified
Score:
2.56

Any other information on results incl. tables

Well-defined erythema (extending beyond application area) and severe oedema present in all 3 rabbits 1 hour after application ended. Moderate/severe to severe erythema with eschar formation persisted in all animals up to the 6 day reading and eschar was still present in 2 animals at the final 14 day reading. The degree of oedema gradually reduced and none persisted in any animal at the 9 day reading.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Tributene was strongly irritant (irritation index 5.92/8) to the skin of male rabbits.
Executive summary:

Tributene was strongly irritant (irritation index 5.92/8) to the skin of male rabbits when the test material was applied under occlusive conditions. The mean erythema and oedema scores (according to Appendix VI of the 6th amendment (79/831/EEC)) were 3.33 and 2.56 respectively.