Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study perfomed according to OECD and GLP guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1990

Materials and methods

Test guideline
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:
Reaction mass of [trans-1,1,4,4-Tetramethoxy-2-butene + cis-1,1,4,4-Tetramethoxy-2-butene]
EC Number:
900-110-7
Cas Number:
5370-08-1
Molecular formula:
C8H16O4
IUPAC Name:
Reaction mass of [trans-1,1,4,4-Tetramethoxy-2-butene + cis-1,1,4,4-Tetramethoxy-2-butene]

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
2 males, 1 female

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48
Score:
0
Max. score:
0
Reversibility:
fully reversible
Other effects:
no other effects observed

Any other information on results incl. tables

-

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not irritating
Executive summary:

Under the conditions of this experiment, C4-diacetal was found to cause a primary irritation score of 0.11, when applied to intact rabbit skin. Local signs (mean values from 1 hour to 72 hours) consisted of grade 0.25 erythema and grade 0.00 edema.

In the area of application, no staining of the treated skin by pigment or coloring of the test article was observed.

No corrosive effect occurred on the skin of any animal at measuring interval.

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