Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited documentation, no data on compound purity, animals were dosed at the ear for 24 hours

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Principles of method if other than guideline:
1 male + 1 female New Zealand White rabbit, ear, 500 mg/rabbit moisted with water, fixed with a tape, exposure time: 24 h, then cleaning with water, soap and oil, post exposure observation time: 14 days
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Phthalic anhydride
EC Number:
201-607-5
EC Name:
Phthalic anhydride
Cas Number:
85-44-9
Molecular formula:
C8H4O3
IUPAC Name:
1,3-dihydro-2-benzofuran-1,3-dione

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
White New Zealand rabbits, weight 3 - 4 kg

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: moisted with water
Controls:
not required
Amount / concentration applied:
Amount: 500 mg
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
2
Details on study design:
No further data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 0, 2 d, 7 d
Score:
0
Max. score:
4
Reversibility:
other: score was 0 at any time point
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
no data
Other effects:
no data

Any other information on results incl. tables

Both rabbits: no reaction was observed (score: 0).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

Method: application of 500 mg/animal of the test substance at the inside of rabbit ears of 2 animals

Result: substance is not irritating, no edema and no erythema was seen at any time point

Reference: Thyssen/Bayer AG (1979)