Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

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

Constituent 1
Chemical structure
Reference substance name:
Barium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate
EC Number:
231-494-8
EC Name:
Barium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate
Cas Number:
7585-41-3
Molecular formula:
C18H13ClN2O6S.Ba
IUPAC Name:
barium 4-[(5-chloro-4-methyl-2-sulfonatophenyl)diazenyl]-3-hydroxy-2-naphthoate
Test material form:
solid: nanoform
Details on test material:
- Name of test material (as cited in study report): Litholscharlach 3700 / C.I.Pigmentred 48:1, Monoazofarbstoff.
- Analytical purity: 100 %

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): Litholscharlach 3700 / C.I.Pigmentred 48:1, Monoazofarbstoff.
- Analytical purity: 100 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Wiga, Ottobrunn, D.
- Mean weight at study initiation: males 137 g, females 123 g

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 suspension
- 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:
LD50 was estimated approximately

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Mortality:
0/10 animals died after the 24h h exposure
Clinical signs:
no abnormalities detected
Body weight:
Not reported
Gross pathology:
No abnormalities detected
Other findings:
- After 24 hours: 10/10 red substance residues, local erythema not detectable.
- After 8 days: 10/10 animals: pink-coloured substance residues

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met