2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium methyl sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Federal Hazardous Substances Labelling Act (Section 191.12)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium chloride

EC Number:

248-053-0

EC Name:

2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium chloride

Cas Number:

26850-47-5

Molecular formula:

C19H23ClN4O2S

IUPAC Name:

2-[(E)-{4-[Ethyl(2-hydroxyethyl)amino]phenyl}diazenyl]-6-methoxy-3-methyl-1,3-benzothiazol-3-ium chloride

Test material form:

solid

Details on test material:

see below

Test animals / tissue source

Species:

rabbit

Details on test animals or tissues and environmental conditions:

not specified

Test system

Details on study design:

Tests for eye irritation in albino rabbits were conducted as outlined in the Federal Hazardous Substances Labelling Act (Section 191.12 of the Regulations).

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Remarks on result:

other:

Remarks:

see box "irritant / corrosive response data"

Irritant / corrosive response data:

One hour - The conjunctiva of all rabbits showed a mild degree of inflammation (hyperaemia, grade 1); Chemosis was recorded as grade 1, and there was a discharge (lacrimation). In addition, the conjunctiva was coloured blue. In 24 and 36 hours, the local changes were essentially the same. After 48 hours, the bluish colour of the conjunctiva was less conspicuous. After 72 hours, the local changes (hyperaemia, Chemosis) had almost completely disappeared, but lacrimation continued in two of the six rabbits for approximately 10 days. One rabbit showed a 1 mm area of injury of the conjunctiva from 24 to 72 hours after treatment, as identified by the fluorescein test (possibly due to rubbing the eye against the cage).

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

In an in vivo eye irritation study the test item was applied to the eye of rabbits as outlined in the Federal Substances Labelling Act (Section 191.12 of the Regulations). By comparison of the eye changes reproduced in the "Guides" prepared by the Dermal Toxicity Branch of the Bureau of Scientific Standards and Evaluation, Food and Drug Administration, the material is not an eye irritant.

Executive summary:

In an in vivo eye irritation study the test item was applied to the eye of rabbits as outlined in the Federal Substances Labelling Act (Section 191.12 of the Regulations). By comparison of the eye changes reproduced in the "Guides" prepared by the Dermal Toxicity Branch of the Bureau of Scientific Standards and Evaluation, Food and Drug Administration, the material is not an eye irritant. Due to a poor documentation of the results this report was assigned with a Klimisch score of 4.