Dilithium disodium (5,5'-diamino-(μ-4,4'-dihydroxy-1:2-κ-2,O4,O4',-3,3'-[3,3'-dihydroxy-1:2-κ-2-O3,O3'-biphenyl-4,4'-ylenebisazo-1:2-(N3,N4-η:N3',N4'-η)]-dinaphthalene-2,7-disulfonato(8)))dicuprate(2-)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-11-01 to 1991-01-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline-conform study under GLP without deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dilithium disodium (5,5'-diamino-(μ-4,4'-dihydroxy-1:2-κ-2,O4,O4',-3,3'-[3,3'-dihydroxy-1:2-κ-2-O3,O3'-biphenyl-4,4'-ylenebisazo-1:2-(N3,N4-η:N3',N4'-η)]-dinaphthalene-2,7-disulfonato(8)))dicuprate(2-)

EC Number:

407-230-4

EC Name:

Dilithium disodium (5,5'-diamino-(μ-4,4'-dihydroxy-1:2-κ-2,O4,O4',-3,3'-[3,3'-dihydroxy-1:2-κ-2-O3,O3'-biphenyl-4,4'-ylenebisazo-1:2-(N3,N4-η:N3',N4'-η)]-dinaphthalene-2,7-disulfonato(8)))dicuprate(2-)

Cas Number:

126637-70-5

Molecular formula:

Hill formula: C32 H16 Cu2 Li2 N6 Na2 O16 S4 CAS formula: C32 H16 Cu2 N6 O16 S4. 2Li 2Na

IUPAC Name:

dicopper(2+) dilithium(1+) disodium 4,4'-bis[2-(8-amino-1-oxido-3,6-disulfonatonaphthalen-2-yl)diazen-1-yl]-[1,1'-biphenyl]-3,3'-bis(olate)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Remarks:

Distilled water

Details on dermal exposure:

TEST SITE
- Area of exposure: 25 cm2 (5x5 cm) for males and 18 cm2 (3.5x3.5 cm) for females
- % coverage: ca 10%
- Type of wrap if used: The formulation was applied by application on a gauze patch fixed successively to aluminium foil and flexible bandage, with drops of petrolatum.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was removed with tissue moistened with tap-water.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight.
- Concentration (if solution): 200 mg/ml
- Constant volume or concentration used: yes, 10 ml/kg body weight.
- For solids, paste formed: no

VEHICLE
- Amount(s) applied (volume or weight with unit): 10 ml/kg body weight
- Concentration (if solution): distilled water was used
- Lot/batch no. (if required): distilled water was used

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
Mortality/Viabity: At periodic intervals on the day of dosing (day 1) and twice daily thereafter for 14 days.
Weighing: Days 1 (pre-administration), 8 and 15.
Symptoms: At periodic intervals on the day of dosing (day 1) and once daily thereafter for 14 days. All signs of reaction to treatment were recorded with particular attention paid to changes in the skin (treated skin), fur, eyes and mucous membranes, as well as to behaviour pattern, tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, others see above

Statistics:

No statistics applied.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: No clinical signs of ill health or behavioural changes were seen during the observation period. No signs of skin irritation were observed on the treated area during the study period.

Gross pathology:

No treatment-related sign of toxicity. Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities.

Other findings:

All animals showed blue staining of the treated skin by the test substance.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 value of the substance in rats was established as exceeding 2000 mg/kg body weight. No classification of the test item as to its dermal toxicity properties according to both the old EEC Directive 83/467/ECC and the new CLP regulation EC 1272/2008.