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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
comparable to guideline study with acceptable restrictions
Remarks:
Observation period only 72 hours. Erythema not scorable for most animals at 24h reading.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: US Code of Federal Regulations, Title 16, Section 1500.41
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24h exposure, scoring only at 24h and 72h
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetramethyl 2,2'-[1,4-phenylenebis[imino(1-acetyl-2-oxoethane-1,2-diyl)azo]]bisterephthalate
EC Number:
271-176-6
EC Name:
Tetramethyl 2,2'-[1,4-phenylenebis[imino(1-acetyl-2-oxoethane-1,2-diyl)azo]]bisterephthalate
Cas Number:
68516-73-4
Molecular formula:
C34H32N6O12
IUPAC Name:
tetramethyl 2,2'-{1,4-phenylenebis[imino(1,3-dioxobutane-2,1-diyl)diazene-2,1-diyl]}diterephthalate
Test material form:
solid: particulate/powder
Details on test material:
Yellow powder
Investing the test material with regard to its particle size is no longer possible (study performed 25 years ago). The data owner informed the lead registrant that the test material does not fulfill the criteria of a nanomaterial according to the EU definition.
No purity provided in study report.

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24h
Observation period:
72h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: no data, just reference to guideline given
- % coverage: no data, just reference to guideline given
- Type of wrap if used: no data, just reference to guideline given

REMOVAL OF TEST SUBSTANCE
- Washing: not specified
- Time after start of exposure: 24h

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
other: partly reversible within 72h (score: 1). No scoring done for later time points.
Remarks on result:
other: Value for animals with intact skin.
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
24 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: Values for animals with intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
5 of 6 animals
Time point:
72 h
Score:
0.2
Max. score:
4
Remarks on result:
other: One animal could not be scored due to yellow staining. Values for animals with intact skin.

Any other information on results incl. tables

Only values from animals with intact skin were used for assessment.

Table 1: Individual skin irritation scores

Rabbit No.

Reaction

24 hours

72 hours

1

Erythema

?

0

 

Edema

0

0

2

Erythema

?

0

 

Edema

0

0

3

Erythema

?

0

 

Edema

0

0

4

Erythema

2

1

 

Edema

0

0

5

Erythema

?

0

 

Edema

0

0

6

Erythema

?

?

 

Edema

1

0

?: no scoring possible due to yellow staining of the skin

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met