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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1980

Materials and methods

Principles of method if other than guideline:
photomaximization test in humans, see details in remarks on material and methods
GLP compliance:
not specified
Type of study:
other: photomaximization test in humans

Test material

Constituent 1
Chemical structure
Reference substance name:
Phthalide
EC Number:
201-744-0
EC Name:
Phthalide
Cas Number:
87-41-2
Molecular formula:
C8H6O2
IUPAC Name:
1(3H)-Isobenzofuranone
Details on test material:
- Name of test material (as cited in study report): Phthalide

In vivo test system

Test animals

Species:
human
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Hydrophilic ointment USP
Concentration / amount:
5%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Hydrophilic ointment USP
Concentration / amount:
5%
No. of animals per dose:
25 humans
Positive control substance(s):
not required

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
no effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 25.0. Clinical observations: no effects.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
no effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 25.0. Clinical observations: no effects.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information