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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: similar to respective guideline but reported only in brief

Data source

Reference
Reference Type:
other: short report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Principles of method if other than guideline:
Single application of 500 mg of the substance moistened with oil, onto the shaved partly intact and partly scarificed back of each of 2 rabbits for 24 hours. The substance was held in place by a plaster. After removing of the plaster the animals were observed for up to 7 days.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
8,9,10,11-tetrachloro-12H-phthaloperin-12-one
EC Number:
244-007-9
EC Name:
8,9,10,11-tetrachloro-12H-phthaloperin-12-one
Cas Number:
20749-68-2
Molecular formula:
C18H6Cl4N2O
IUPAC Name:
8,9,10,11-tetrachloro-12H-isoindolo[2,1-a]perimidin-12-one
Test material form:
other: powder
Details on test material:
IUCLID4 Test substance: :
pure technical product

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
no data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: oil
Controls:
other: the opposite side served as control
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
2
Details on study design:
Single application of 500 mg of the substance moistened with oil, onto the shaved partly intact and partly scarificed back of each of 2 rabbits for 24 hours. The substance was held in place by a plaster. After removing of the plaster the animals were observed for up to 7 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: irritational effects: scarificed skin
Basis:
mean
Time point:
other: 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: irritational effects: intact skin
Basis:
mean
Time point:
other: up to 7 days
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritant / corrosive response data:
72 hours post application, only the scarificed area of both rabbits showed a marked reddening of the skin (scores not given) which were fully reversible within 7 days. No other irritating effects were observed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

Single application of 500 mg Macrolex Rot EG moistened with oil, onto the shaved partly intact and partly scarificed back of each of 2 rabbits for 24 hours. The substance was held in place by a plaster. After removing of the plaster the animals were observed for up to 7 days. 72 hours post application , omly the scarificed area of both rabbits showed a marked reddening of the skin (score 2/4) which were fully reversible within 7 days. Intact skin showed no reaction. Therefore, Macrolex Rot EG is evaluated as non-irritant to the intact skin of rabbits