Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from secondary source

Data source

Reference
Reference Type:
secondary source
Title:
Fiber Reactive Dyes Toxicological Profiles December 1981
Author:
U.S. Consumer Product Safety Commission
Year:
1981
Bibliographic source:
Fiber Reactive Dyes Toxicological Profiles December 1981,PB83-168732

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the eye irritation potential of Reactive ORANGE 4 in rabbits
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
1,5-Naphthalenedisulfonic acid, 2-[2-[6-[(4,6-dichloro-1,3,5-triazin-2-yl)methylamino]-1-hydroxy-3-sulfo-2-naphthalenyl]diazenyl]-, sodium salt (1:3)
EC Number:
602-402-7
Cas Number:
12225-82-0
Molecular formula:
C24H16Cl2N6O10S3.3Na
IUPAC Name:
1,5-Naphthalenedisulfonic acid, 2-[2-[6-[(4,6-dichloro-1,3,5-triazin-2-yl)methylamino]-1-hydroxy-3-sulfo-2-naphthalenyl]diazenyl]-, sodium salt (1:3)
Test material form:
solid
Details on test material:
Name of the test chemical: 1,5-Naphthalenedisulfonic acid, 2-[2-[6-[(4,6-dichloro-1,3,5-triazin-2-yl)methylamino]-1-hydroxy-3-sulfo-2-naphthalenyl]diazenyl]-, sodium salt (1:3)
Common Name: REACTIVE ORANGE 4
Molecular formula: C24H16Cl2N6O10S3.3Na
Molecular Weight: 781.473 g/mol
Substance Type:Organic
Physical State: Solid
Specific details on test material used for the study:
Name of the test chemical: 1,5-Naphthalenedisulfonic acid, 2-[2-[6-[(4,6-dichloro-1,3,5-triazin-2-yl)methylamino]-1-hydroxy-3-sulfo-2-naphthalenyl]diazenyl]-, sodium salt (1:3)
Common Name: REACTIVE ORANGE 4
Molecular formula: C24H16Cl2N6O10S3.3Na
Molecular Weight: 781.473 g/mol
Substance Type:Organic
Physical State: Solid

Test animals / tissue source

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

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
no data available
Duration of treatment / exposure:
no data available
Observation period (in vivo):
no data available
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
no data available
Details on study design:
no data available

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: no data available
Reversibility:
not specified
Remarks on result:
no indication of irritation
Other effects:
no data available

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
No irritation effects were observed when Reactive Orange 4 was instilled into rabbit eyes.
Hence, Reactive Orange 4 can be considered to be not irritating to eyes.
Executive summary:

The ocular irritation potential of Reactive Orange 4 was assessed in rabbits.

Reactive Orange 4 was instilled into the eyes of rabbits and observed for signs of irritation (dose, duration not mentioned).

No irritation effects were observed when Reactive Orange 4 was instilled into rabbit eyes.

Hence, Reactive Orange 4 can be considered to be not irritating to eyes.