[7-hydroxy-8-[(2-methoxyphenyl)azo]-2-naphthyl]trimethylammonium chloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Data source

Reference

Reference Type:

secondary source

Title:

OPINION ON Basic Red 76

Author:

Scientific Committee on Consumer Safety SCCS

Year:

2011

Bibliographic source:

Scientific Committee on Consumer Safety SCCS - adopted at its 10th plenary meeting of 22 March 2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

[7-hydroxy-8-[(2-methoxyphenyl)azo]-2-naphthyl]trimethylammonium chloride

EC Number:

269-941-4

EC Name:

[7-hydroxy-8-[(2-methoxyphenyl)azo]-2-naphthyl]trimethylammonium chloride

Cas Number:

68391-30-0

Molecular formula:

C20H22ClN3O2

IUPAC Name:

7-hydroxy-8-[(2-methoxyphenyl)diazenyl]-N,N,N-trimethylnaphthalen-2-aminium chloride

Constituent 2

Reference substance name:

Basic Red 76

IUPAC Name:

Basic Red 76

Details on test material:

- Name of test material (as cited in study report):Basic Red 76- Molecular formula (if other than submission substance):C20H22N3O2 Cl- Molecular weight (if other than submission substance):371.86g/mol- Substance type:Organic- Physical state:SolidPurityDetermined by HPLC = 98.1 % (AUC, HPLC), - Impurities (identity and concentrations):water content = 5.1%(w/w); Monomethyl sulphate 11.8% (w/w); o-anisidine = 5ppm; Sulphated ash 0.4% (w/w); Chloride 1.6% (w/w); Sodium = 630 ppm; Calcium = 590 ppm; Saccharose = 25.8%(w/w)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALSAge at study initiation: Adult New Zealand White albino male rabbits

Test system

Vehicle:

not specified

Controls:

yes

Amount / concentration applied:

100 mg of test substance

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours to 7 days

Number of animals or in vitro replicates:

3 rabbits – 1 male and 2 females

Details on study design:

TEST SITEArea of exposure: conjuctival sac of the left eye% coverage:Type of wrap if used:REMOVAL OF TEST SUBSTANCEWashing (if done): The substance remained in permanent contact with the eyes until rinsing with warm tap waterTime after start of exposure: 24 hours after instillation.SCORING SYSTEM: The eye irritation reactions were scored approximately 1, 24, 48 and 72 hours and 7 days after instillation of the test solution.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: upto 72 hrs

Reversibility:

fully reversible within: 72 hrs

Remarks on result:

other: mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis.

Irritant / corrosive response data:

Slight red staining of the treated eyes by the test item was observed in all animals at the 1- and 24- hour reading and persisted in two animals up to 48 hours and in one animal up to 72 hours after treatment.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

Eye irritation study was carried out on New Zealand White rabbits according to OECD 405 Guidelines to determine the irritation potency of Basic Red 76.The instillation of the undiluted Basic Red 76 into the eyes resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis.These effects were reversible and were no longer evident 72 hours after treatment. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. Slight red staining of the treated eyes by the test item was observed in all animals at the 1- and 24- hour reading and persisted in two animals up to 48 hours and in one animal up to 72 hours after treatment. The study was terminated seven days after instillation.Under the conditions of the study, Basic Red 76 was considered to be not irritating to rabbit eyes.

Executive summary:

Eye irritation study was carried out on New Zealand White rabbits according to OECD 405 Guidelines to determine the irritation potency of Basic Red 76.

 

100 mg of Basic Red 76 was instilled into the conjunctival sac of the left eye of the test animals. The substance remained in permanent contact with the eyes until rinsing with warm tap water, 24 hours after instillation. The right eyes served as controls. The eye irritation reactions were scored approximately 1, 24, 48 and 72 hours and 7 days after instillation of the test solution.

 

The instillation of the undiluted Basic Red 76 into the eyes resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis.

 

These effects were reversible and were no longer evident 72 hours after treatment. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. Slight red staining of the treated eyes by the test item was observed in all animals at the 1- and 24- hour reading and persisted in two animals up to 48 hours and in one animal up to 72 hours after treatment. The study was terminated seven days after instillation.

 

Under the conditions of the study, Basic Red 76 was considered to be not irritating to rabbit eyes.