Registration Dossier

Diss Factsheets

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 study according EU/OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
8-tert-butyl-2-(chloromethyl)-1,4-dioxaspiro[4.5]decane
EC Number:
601-507-5
Cas Number:
118135-28-7
Molecular formula:
C13H23ClO2
IUPAC Name:
8-tert-butyl-2-(chloromethyl)-1,4-dioxaspiro[4.5]decane

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-72h
Score:
2.7
Max. score:
3
Reversibility:
not fully reversible within: 14d
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-72h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 14d
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24-72h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 14d
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-72h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-72h
Score:
0.3
Max. score:
1
Reversibility:
not fully reversible within: 14d
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24-72h
Score:
0.7
Max. score:
1
Reversibility:
not fully reversible within: 14d

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU