Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The study is comparable to OECD 402 with acceptable restrictions mostly due to reduced reporting in times prior to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate

EC Number:

226-109-5

EC Name:

Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate

Cas Number:

5281-04-9

Molecular formula:

C18H14N2O6S.Ca

IUPAC Name:

calcium 3-hydroxy-4-[(1E)-2-(4-methyl-2-sulfonatophenyl)diazen-1-yl]naphthalene-2-carboxylate

Test material form:

solid: nanoform

Details on test material:

C.I. Pigment Red 57:1 with "Harzseife" (resinate);
- Name of test material (as cited in study report): Litholrubin 4630
- Analytical purity: 100 %
- Physical state: solid

Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.

Specific details on test material used for the study:

- Name of test material (as cited in study report): Litholrubin 4630

C.I. Pigment Red 57:1, with "Harzseife" (resinate)
- Analytical purity: 100 %
- Physical state: solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeder (Wiga)
- Mean weight at study initiation: males: 133 g, females: 114g

ENVIRONMENTAL CONDITIONS
- not reported

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal, p.c., 50 cm²

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5 g/kg animal
- Concentration (if solution): 50 % aequous solution
- For solids, paste formed: yes

Duration of exposure:

24 h

Doses:

2500 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No weighing was done. Observation was several times at the day of exposure and presumably daily exception of weekends and holidays afterwards.
- Necropsy of survivors performed: yes

Statistics:

None

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 500 mg/kg bw

Mortality:

0/10 animals died after the 24 h exposure

Clinical signs:

other: no abnormalities detected

Gross pathology:

no abnormalities detected

Other findings:

- Other observations: after 24h red substance residues, redness not detectable, after 8 days red substance residues.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met