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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
7 Jun - 12 Jul 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The skin sensitization potential of the test substance at a 10% concentration w/w in alcohol:DEP (75:25) was assessed in a human repeat patch study. A total of 51 subjects participated in the study. Subjects were exposed to 10 induction patches containing 0.2 mL of the test substance at 10% w/w in alcohol:DEP (75:25) under occlusive conditions on a Monday, Wednesday and Friday schedule. Patches were removed 24 hours after each application and patch sites were graded at 48 hours after patch application prior to the next patch application. After a 2-weeks rest period, subjects were challenged with 0.2 mL test substance at 10% w/w in alcohol:DEP (75:25) (24 hour patch exposure). Challenge patch sites were graded at 24, 48 and 72 hours after patch application.
GLP compliance:
no

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:
1,3-dihydro-2-benzofuran-1-one

Method

Type of population:
general
Ethical approval:
confirmed, but no further information available
Subjects:
- Number of subjects exposed: 43 females, 8 males
- Age: 19-7 years
Controls:
Untreated skin served as control.
Route of administration:
dermal
Details on study design:
TYPE OF TEST USED: repeat insult patch test (HRIPT)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: Coverlet adhessive dressing (Beiersdorf Inc.)
- Vehicle / solvent: alcohol:DEP (75:25)
- Concentrations: 10%
- Volume applied: 0.2 mL
- Testing/scoring schedule:
Induction:
Monday, Wednesday and Friday for a total of 10 applications
patch sites were graded at 48 hours after patch application prior to the next patch application
Challenge:
after a 2-weeks rest period for 24 h
- Removal of test substance: 24 h

EXAMINATIONS
- Grading/Scoring system:
0 - No visible reaction
1 - Mild erythema
2 - Well-defined erythema, possible presence of barely perceptible edema
3 - Erythema and edema
4 - Erythema and edema with vesiculation and ulceration

Results and discussion

Results of examinations:
No skin reaction was observed after application of the 10% test substance solution throughout the study.

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the test substance at 10% w/w in alcohol:DEP (75:25) did not indicate any skin irritation or sensitization potential.