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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
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 401 (Acute Oral 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): C.I.Pigmentred 48:1, Monoazofarbstoff / Litholscharlach 3700
- Analytical purity: 100 %

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
-Source: Gassner (Breeder)
- Mean weight at study initiation: males 204 g; females 174 g

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 % aequeous suspension of CMC. A higher concentration than 20 % could not be applicated for technical reasons.
Doses:
3200 mg/kg b.w.; 6400 mg/kg b.w.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Weighing was only performed at the beginning of the study for dose calculation. Observation of clinical signs was several times on the day of administration and once daily afterwards with the exception of weekends and on holidays.
- Necropsy of survivors performed: yes
Statistics:
No statistics were perfomed because (not necessary)

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 400 mg/kg bw
Mortality:
no mortality observed
Clinical signs:
Red feces.
Gross pathology:
no abnormalities detected

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met