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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
A mixture of: pentasodium 7-amino-3-[[4-[[4-[[4-[[4-[(6-amino-1-hydroxy-3-sulfonato-2-naphthyl)azo]7-sulfonato-1-naphthyl]azo]phenyl]amino]-3-sulfonatophenyl]azo]6-sulfonato-1-naphthyl]azo]-4-hydroxynaphthalen-2-sulfonate; a mixture of: pentasodium 7-amino-8-[4-[4-[4-[4-(2-amino-5-hydroxy-7-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate and pentasodium 7-amino-8-[4-[4-[4-[4-(6-amino-1-hydroxy-3-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-hydroxy-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-amino-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate
EC Number:
415-350-3
EC Name:
A mixture of: pentasodium 7-amino-3-[[4-[[4-[[4-[[4-[(6-amino-1-hydroxy-3-sulfonato-2-naphthyl)azo]7-sulfonato-1-naphthyl]azo]phenyl]amino]-3-sulfonatophenyl]azo]6-sulfonato-1-naphthyl]azo]-4-hydroxynaphthalen-2-sulfonate; a mixture of: pentasodium 7-amino-8-[4-[4-[4-[4-(2-amino-5-hydroxy-7-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate and pentasodium 7-amino-8-[4-[4-[4-[4-(6-amino-1-hydroxy-3-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-hydroxy-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-amino-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Amount / concentration applied:
100 mg
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: overall at 24 and 48h
Score:
0.25
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: overall at 24 and 48h
Score:
0.8
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: overall at 24 and 48h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: overall at 24 and 48h
Score:
0
Max. score:
0
Other effects:
Lids were strongly swelled and strong secretion

Applicant's summary and conclusion

Interpretation of results:
other: not classified under Regulation 1272/2008
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS