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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Principles of method if other than guideline:
Internal BASF method was used. A 50% aqueous preparation of the substance has been applied on the back and ear of rabbits for 20 hours, observations were reported after 24h, 48h, 5 days, 6 days 7 days and 8 days.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrogen [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
EC Number:
287-257-4
EC Name:
Hydrogen [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
Cas Number:
85443-67-0
Molecular formula:
C16 H11 Cr N5 O8 S .C11 H25 N O .H
IUPAC Name:
1-Propanamine, 3-[(2-ethylhexyl)oxy]-,(T-4)-[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]hydroxychromate(1-)
Details on test material:
Neozaponorange G
Chromium complex of the azo dye with amine salt

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male 2.66 kg, male 3.99 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
ca. 1 mg of a 50% aqueous test substance preparation
Duration of treatment / exposure:
20 hours
Observation period:
8 days
Number of animals:
2
Details on study design:
Application area: 2.5 x 2.5 cm
Application site: back
The test substance was not washed off.

Results and discussion

In vivo

Results
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Due to substance-colouring, it was not possible to evaluate skin scores. Erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Foi. Cosm. Tox. 13, 355, 1975). No findings reported 8 days after application. The test item was found to cause no irritation when applied to intact rabbit skin.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met