Bis[3-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Remarks:

In vivo

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

September 1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The test was conducted on a similar substance, the complete justification for the Read Across approach is reported at section 13. The original Reliability of the test is 2

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1974

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: U.S.A FDA Federal Register (17 September,1964 § 191.12)

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 1

IUPAC Name:

Similar Substance 1

Test animals / tissue source

Species:

rabbit

Strain:

other: albino rabbit

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
- Concentration: 0.1 ml

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Duration of treatment / exposure:

24 h

Observation period (in vivo):

1, 2, 3, 4, 7, 14, 21 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no
- Time after start of exposure: 24-hours

SCORING SYSTEM: The ocular reactions were scored by the method described by J.H. Draize in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" p 51

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: binocular loupe, hand slit-lamp, After the recording of observations at 24 hours, any or all eyes may be further examined after applying fluorescein.
After flushing out the excess fluorescin with sodium chloride solution or equivalent , injured areas appear yellow

Results and discussion

In vivo

Results

Irritation parameter:

other: dermal effects

Basis:

animal: all

Time point:

21 d

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: See Irritant/corrosive response data

Irritant / corrosive response data:

Corneal opacities developed in all six animals and were still present on day 21, with pannus formation in three animals. Ulceration of the cornea of animal number 2 was observed on day 3. Temporary iritis was observed in three animals. A diffuse deep crimson-red colouration of the conjunctivae and considerable swelling with the eyelids about half closed was observed in all six animals.

Any other information on results incl. tables

The test was conducted according to U.S.A FDA Federal Register (17 September,1964 § 191.12), the value reported in the summary table derived from the following calculation:

Cornea Score * Area of cornea involved*5

Iris score *5

Conjunctivae*Chemosis*Discharge*2

therfore no extrapolation is possible to the single scores associated to the grading after 24 48 and 72 hours, according to the CLP Regulation.

Nevertheless, at the end of the observation period (21 days ) all the animals showed not reversible effects, therefore an evaluation according to the CLP Regulation is possible.

Applicant's summary and conclusion

Interpretation of results:

other: Category 1 (irreversible effects on the eye) according to the CLP Regulation

Conclusions:

The test substance causes irreversible effects on rabbit eyes

Executive summary:

The substance has been tested for eye irritation/corrosion according to the U.S.A guideline Federal Register (17 September,1964 § 191.12) for 21 days of test period. Six albino rabbits are used and, under the test conditions, all the animals gave a positive response.

Corneal opacities developed in all six animals and were still present on day 21, with pannus formation in three animals. Ulceration of the cornea of animal number 2 was observed on day 3. Temporary iritis was observed in three animals. A diffuse deep crimson-red colouration of the conjunctivae and considerable swelling with the eyelids about half closed was observed in all six animals.

The test substance causes irreversible effects on rabbit eyes.