Barium bis[5-chloro-4-ethyl-2-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate]

Endpoint summary

Description of key information

Studies on the irritating potential of the test item were not performed. Since both substances are Ba-salts with comparable structur and similar solubility, information on skin and eye irritation were derived from experimental data of a structural analogue. Several studies in rabbits were performed to evaluate irritating or corrosive properties of the test material to skin or eyes (OECD guideline 403, 404 and AFDO regulation). Application of the test substance did not provoke skin irritation. Treatment of rabbits eyes caused slight conjuctival irritation. All reaction resolved within 2 days or were below  the treshold of regualtion. Therefore, the substance is considered to be not-irritating.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

october 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well documented, GLP conform, according then in force OECD guideline (7 days post observation period only), acclimatization period not mentioned, in life data not given, rationale for vehicle (undiluted PEG 400) not given

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Chemisch pharmazeutische Fabrik Dr. K. Thomae, 88400 Biberach
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 2.3 - 2.7 kg
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: /

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 ·C
- Humidity (%): 55 ± 20 %
- Photoperiod (hrs dark / hrs light): 12 hours per day

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: PEG 400

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): pasted with 0.9 ml polyethylene glycol 400

VEHICLE (PEG 400, Riedel-de Häen Ag, Seelze)
- Amount(s) applied (volume or weight with unit): about 1 ml

Duration of treatment / exposure:

4h

Observation period:

30 - 60 minutes, and 24, 48 and 72 hours after removal of the patches

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal region
- % coverage: 25 cm2
- Type of wrap if used: surgical plaster and semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 4h, with luke warm water

SCORING SYSTEM: Draize

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: all time points

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

mean

Time point:

other: all time p oints

Score:

0

Max. score:

4

Irritant / corrosive response data:

Three days after the application 2 animals showed very slight up to well-defined erythema. The skin surfaces were slightly discolourered, and dry-rough and fine up to coarse scales were noted. Seven days after the application all signs of irritation were reversible.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: limited information on test substance, enviromental conditions and animals

Qualifier:

equivalent or similar to guideline

Guideline:

other: see below

Principles of method if other than guideline:

The procedure adopted was the technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

GLP compliance:

no

Remarks:

prior to GLP-introduction

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: russian breed
- Housing: singly in wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

eyes washed: 30 seconds
eyes unwashed: whole observation period

Observation period (in vivo):

observed after 24 hours and 2, 3, 4 and 7 days

Number of animals or in vitro replicates:

3 per sex

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 30 seconds with warm water
- Time after start of exposure: 30 sec

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: all time points

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: all time points

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: all time points

Score:

0

Max. score:

3

Irritant / corrosive response data:

The irritation index was found to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The primary-irritation index, which serves as a measure of the acute irritation provoked by the substance, was found to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae. Therefore the test item is to be considered as non-irritant to the eye of rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Read across justification

Irritating/corrosive properties of the test item were not examined. The test item shares high structural similarity to an analogue substance, since both are Ba-salts which differ inone additional ethyl-group only. Moreover, both substances are solid pigmets and poor soluble in water and octanol. Therefore, it is acceptable to derive information on skin and eye irritation from experimental data of the analogue substance.

Procedure and observations

Two key tests each and several supporting studies were performed to evaluate the irritating potential of the test substance to skin and eyes.

In the first, pre-GLP study, six rabbits (3/sex/dose) were each administered a single dose of 0.5 g given as 50% suspension of the test substance onto shaved skin of back and flanks (Ciba 1974). Occlusive application of the test material to intact rabbit skin for 24 hours did not cause any reaction on animals skin.

The second, GLP and OECD guideline study was conducted in 1993 (Hoechst 1993). The test material (0.5g, 50% solution) was applied onto shaved, intact dorsal skin of 6 rabbits (3/sex/dose) for 4h under semi-occlusive conditions. After removal of the test substance effects and symptoms were scored at 0.5, 1, 24, 48 and 72h. Slight erythema formation was observed. All effects resolved fully within 7 days.

In addition, several supporting studies on skin irritation studies are available (Hoechst 1973, 1982 and 1988). In two of these tests the test item did not cause any skin reaction; in a third assay slight erythema were observed. All symptoms resolved within post observation period. All of the supporting studies are described very briefly, include no or only limited data on method and animals or were performed with a mixture of unknown composition. Therefore, these tests are considered as not reliable or not assignable.

To evaluate the eye irritation potential of the test material, six rabbits (3/sex/dose) were each administered a single ocular dose of 100 mg of the test substance and observed for seven days after instillation (Ciba 1974). In half of the animals the eye was rinsed 30 sec after installation, the eyes of the remaining animals were not rinsed. The substance did not cause any effect. Neither swelling, not redness or chemosis were observed.

In a second key study (Hoechst 1993) 0.1 g test material were administrated into the conjunctival sac of one each rabbits eye. The eyes were not rinsed and effects were scored 1, 24, 48 and 72h after application. The single instillation of the test material into the eye of the rabbits elicited slight swelling and injected blood vessels which was not fully reversible within 2 days.

In addition, several supporting studies on eye irritation tests are available (Hoechst 1973, 1982 and 1988). In all of these assays the test substance induced slight sweling and redness. All symptoms resolved latest within 48h.

There are no data available about irritation to the respiratory system.

Discussion

Application of the test substance onto skin did not cause corrosion or irritation. Appllication into the conjunctival sac of the eye caused slight conjuctival irritation which was latest reversible within 2 days and which was below the treshold of regulation.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified as irritating for skin or eyes under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for irritation under Regulation (EC) No. 1272/2008,as amended for the second time in Directive (EC 286/2011).