Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 260-906-9 | CAS number: 57693-14-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
- EC Number:
- 260-906-9
- EC Name:
- Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
- Cas Number:
- 57693-14-8
- Molecular formula:
- C40H20CrN6O14S2.3Na
- IUPAC Name:
- trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
- Test material form:
- not specified
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 67 mg or 100 µl - Duration of treatment / exposure:
- no defined end of exposure
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- A single application of 0.1 ml (67 mg) ofthe test material was administered to the non irrigated eye of 3 rabbits. Ocular reactions were recorded 1, 24, 48 and 72 hours and 7 days after administration.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2, 3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Reversibility:
- fully reversible within: 7 d
- Other effects:
- none observed
Any other information on results incl. tables
Rabbit no. & sex |
65589 male |
65666 male |
65670 male |
||||||||||||
IPR = 3 |
IPR = O+ |
IPR = O+ |
|||||||||||||
time after treatment (h) |
1 |
24 |
48 |
72 |
7*24 |
1 |
24 |
48 |
72 |
7*24 |
1 |
24 |
48 |
72 |
7*24 |
CORNEA E = degree of opacity F = area of cornea involved |
0 0 |
1 2
|
1 1
|
0 0 |
0 0 |
0 0 |
1 1 |
1 1
|
0 0 |
0 0 |
0 0 |
1 1 |
1 1 |
0 0 |
0 0 |
score (E × F) × 5 |
0 |
10 |
5 |
0 |
0 |
0 |
5 |
5 |
0 |
0 |
0 |
5 |
5 |
0 |
0 |
iris D |
0 |
1 |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
score (D × 5) |
0 |
5 |
5 |
0 |
0 |
0 |
5 |
5 |
0 |
0 |
0 |
5 |
5 |
0 |
0 |
CONJUNCTIVAE A = redness B = chemosis C = discharge |
2 2 3sf |
2 2 2sf |
2 2 1sf |
2 1 1sf |
0 0 0sf |
2 2 2sf |
2 2 2sf |
2 1 1sf |
2 1 1sf |
0 0 0sf |
2 2 2sf |
2 2 2sf |
2 1 1sf |
2 1 0sf |
0 0 0sf |
score (A+B+C)× 2 |
14 |
12 |
10 |
8 |
0 |
12 |
12 |
8 |
6 |
0 |
12 |
12 |
8 |
6 |
0 |
total score |
14 |
27 |
20 |
8 |
0 |
12 |
22 |
18 |
6 |
0 |
12 |
22 |
18 |
6 |
0 |
IPR = Initial pain reaction; + = one drop of local anaesthetic instilled into both eyes 1 to 2 minutes before treatment ; Sf = black staining of the fur around the treated eye
Applicant's summary and conclusion
- Interpretation of results:
- other: eye irritant according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Eye irritant.
- Executive summary:
Method
A single application of 0.1 ml (67 mg) of test material was administered to the non irrigated eye of 3 rabbits. Ocular reactions were recorded 1, 24, 48, and 72 hours and 7 days after administration.
Results
The test material produced scattered and diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation. Black staining of the fur was noted around all treated eyes throughout the study. All treated eyes appeared normal at the 7-day observation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
