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

Endpoint summary

Description of key information

Not irritating for skin
Corrosive for eye

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

September 1985

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: GAUKLER: 0-6050 OFFENBACH/MAIN, FRG
- Weight at study initiation: 2.63 kg
- Housing: single housed in a cage made of stainless steel with wire mesh walk floors, floor area: 40 cm x 51 cm
- Diet: kliba 341, 4 mm, firma klingentalmuehle ag ch-4303 kaiseraugst. switzerland (about 130 g per animal per day)
- Water: 250 ml, tap water
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): fully air-conditioned room
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light from 6:00 AM to 6:00 PM

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution): 50 % aqueous formulation w/w

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g of the suspension

Duration of treatment / exposure:

1 hour

Observation period:

30 — 60 minutes after removal of the test patches and 24 h. 48 h, 72 h, after the beginning of application

Number of animals:

3 male rabbits

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm X 2.5 cm
- Type of wrap if used: 0.5 mm layer, test patches are secured in position with a porous dressing (four layers of absorbent gauze + porous bandage).

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1h, 24, 48, 72 h

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Interpretation of results:

other: Not classified according to the CLP Regulation

Conclusions:

The test substance is not irritating for rabbit skin.

Executive summary:

The substance has been tested for skin irritation according to the OECD guideline 404. The substance was applied to the shaved skin of 3 males rabbits. The test item was removed after 1 hour and the effects were observed for subsequently 72 hours. During the observation period no effects were seen into the shaved area of the rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

GLP compliance:

no

Species:

rabbit

Strain:

other: albino rabbit

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation

 

The skin irritation potential of the target substance was evaluated by means of Read Across approach. The complete justification for the Read Across approach is detailed at section 13.

No studies are available on the substance in itself, therefore the whole data set of the most similar substances were considered in order to perform the assessment. The substances considered for the evaluation are different salification of the Target substance.

A complete summary of the available data is attached. The results of the tests are concordant.

The study selected as the most representative and conservative was performed on Similar Substance 3 [DyStar Colours Distribution GmbH, 1985]. The test was conducted according to the OECD Guideline 404 and, under the test condition, the similar substance showed a very low interaction with rabbit skin.

All values of erythema and oedema are zero, therefore the substance is considered as not irritating for rabbit skin.

 

Eye Irritiation

 

The eye irritation potential of the target substance was evaluated by means of Read Across approach. The complete justification for the Read Across approach is detailed at section 13.

No studies are available on the substance in itself, therefore the whole data set of the most similar substances were considered in order to perform the assessment. The substances considered for the evaluation are different salification of the Target substance; the results of the available tests are variable from not irritant to corrosive as described in the complete summary attached.

The study selected as the most representative and conservative was performed on Similar Substance 1 [Huntsman Textile Effects GmbH, 1973]. 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

 

therefore no extrapolation is possible to the single score 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 effects not fully reversible, therefore an evaluation according to the CLP Regulation is possible.

Effects on eye irritation: corrosive

Justification for classification or non-classification

SKIN IRRITATION/CORROSION

A corrosive substance is a substance that produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least 1 tested animal after exposure up to 4 hour duration.

To classify a substance as irritant, the major criterion is that at least 2 of 3 tested animals have a mean score of ≥ 2,3 - ≤ 4,0.

Category 2:

- Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

- Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

- In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical eposure in a single animal but less than the criteria above.

No dermal effects were observed under the test conditions and the mean values from gradings at 24, 48 and 72 hours were 0 for all the animals.

Based on the esperimental results, the substance is not classified as skin irritant because in the performed tests it doesn't meet the classification criteria of the CLP Regulation EC n. 1272/2008.

EYE IRRITATION

Serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application.

Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.

Irreversible effects on the eye (Category 1):

If, when applied to the eye of an animal, a substance produces:

- at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or

- at least in 2 of 3 tested animals, a positive response of corneal opacity ≥ 3 and/or iritis > 1,5 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.

The effects on rabbit eye are not fully reversible within the observation period of 21 days, therefore the substance is classified as Eye Damage 1, H318: Causes serious eye damage, according to the CLP regulation 1272/2008.