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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Food and Drug Administration of the U.S.A. in The Federal Register (17 September 1964 § 191.11)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Reaction mass of disodium [N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-) and hydrogen[N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)
Molecular formula:
not applicable
IUPAC Name:
Reaction mass of disodium [N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-) and hydrogen[N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)
Test material form:
not specified

Test animals

Species:
other: albino rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped and abraded
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g dissolved in 0.5 ml of water to form a paste

VEHICLE
- Amount(s) applied: 0.5 ml
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours
Number of animals:
6 rabbits
Details on study design:
TEST SITE
- Area of exposure: trunk
- Type of wrap if used: 1 inch x 1 inch gauze, 2 single layers thick, secured with impervious material kept in place by adhesive tape

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3, #4, #5
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Intact skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0.66
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3, #4, #5
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0.66
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritant / corrosive response data:
All the rabbits except for the #6 have not shown signs of erythema or edema formation after exposure to test item. The rabbit #6 showed a very slight erythema and edema formation at 72 hours after exposure to test substance.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not irritant
Executive summary:

Method

The substance has been tested according to the procedure employed by the Food and Drug Administration of the U.S.A. in The Federal Register (17 September 1964 § 191.11).

Six rabbits were used in abraded and intact skin tests. The test substance was introduced under a square patch such as surgical gauze measuring 1 inch x 1 inch, two single layers thick. 0.5 g of the test substance were dissolved in 0.5 ml of water to forma a paste which was applied under the gauze.

The animals were immobilized with patches secured in place by adhesive tape. The entire trunk of the animal was then wrapped with an impervious material for the 24-hour period of exposure.

An equal number of exposures were made on areas of skin that have been previously-abraded. The abrasions were minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding. After 24 hours exposure, the patches were removed and the resulting reactions were evaluated. Readings were again made at the end of a total of 72 hours (48 hours after the first reading).

Conclusion

Not irritant