Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984-09-04 to 1984-09-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

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
Chemical structure
Reference substance name:
Dihydro-3-(tripropenyl)furan-2,5-dione
EC Number:
295-556-6
EC Name:
Dihydro-3-(tripropenyl)furan-2,5-dione
Cas Number:
92077-08-2
Molecular formula:
R-C4H3O3 , whereas R=C8-C10-alkyl-(branched, unsaturated)
IUPAC Name:
3-[(1E)-2-methyloct-1-en-1-yl]oxolane-2,5-dione

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Species: Albino New Zealand rabbits
Origin: Hoechst AG, Kastengrund, conventional breeding
Number of animals: 3
Identification of animals: numbered ear tags
Animal weight: 3,1 - 3,8 kg
Animal husbandry: in fully air-conditioned rooms in individual cages (battery cages)
Room temperature: 20 ± 2 °C
rel. Humidity: 55 ± 10%
Light time: 12 hours a day
Food: Altromin 2123 maintenance diet - Rabbits; Altromin GmbH, Lage / Lippe, ad libitum
Water: deionized, chlorinated water from automatic drinkers, ad libitum

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0,5ml
Duration of treatment / exposure:
4h
Observation period:
14d
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1.6
Max. score:
2
Reversibility:
fully reversible within: 14d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1.1
Max. score:
1.7
Reversibility:
fully reversible within: 14d
Other effects:
Skin dry, brittle and scaly after 14d

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The registered substance is considered to be skin irritating.
Executive summary:

The skin irritating potential of tripropenyl succinic anhydride was investigated according to test guidline OECD 404. Very slight to well-defined erythema and very slightly to moderate edema were seen on during the observation period. All the effects were fully reversible. The average values of erythema and edema scores at time points of 12, 48 and 72 h after treatment are 1.6 and 1.1, respectively. In addition, Skin dry, brittle and scaly were observed after 14d. Based on these findings, the registered substance is considered to be skin irritating.