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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1975
Reliability:
3 (not reliable)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Principles of method if other than guideline:
A 10% and 5% water solution of the dye was applied 5 times in 5 days (Monday-Friday, 1 time a day) at a rate of 0.5 ml to the uninjured side and mechanically depilated skin of 6 rabbits.












GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
7-acetamido-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2-sulphonic acid, sodium salt
EC Number:
287-574-8
EC Name:
7-acetamido-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2-sulphonic acid, sodium salt
Cas Number:
85536-87-4
Molecular formula:
C20H19N3O11S3.xNa C20H(19-x)N3NaxO11S3
IUPAC Name:
7-acetamido-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2-sulphonic acid, sodium salt
Test material form:
solid: particulate/powder
Details on test material:
Reactive Orange 72/78

Test animals

Species:
rabbit
Strain:
other: Gelb-Silber
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5-2 Kg
- Housing: Individual cage
- Diet: ERKA 8300 (Robert Koch oHG/Hamm) mixed feeding ad libitum
- Water: tap water ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
physiological saline
Details on exposure:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: surgical gauze and elastic bandage PVC

Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
5 days
Frequency of treatment:
daily
Doses / concentrationsopen allclose all
Remarks:
0.5 mL of 10% solution
Remarks:
0.5 mL of 5% solution
No. of animals per sex per dose:
6 rabbits
Control animals:
yes, concurrent no treatment

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Dermal irritation:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified

Effect levels

Dose descriptor:
other: Erythema index
Effect level:
> 10 other: %
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: There were no signs of irritation and no signs of systemic toxicity

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The test substance is not irritating to the skin after 5 daily administrations to the rabbit skin at concentrations of 5 and 10%.
Executive summary:

In a test on dermal tolerance after repeated administration, the 10% and 5% dye-preparation was applied once daily for 5 days in an amount of 0.5 ml each to the mechanically depilated and uninjured flank skin of 6 rabbits.

No signs of irritation were observed.