Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
Manganese, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex
EC Number:
226-102-7
EC Name:
Manganese, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex
Cas Number:
5280-66-0
Molecular formula:
C18H11N2O6SClMn
IUPAC Name:
10-carboxy-19-chloro-18-methyl-15,15-dioxo-12λ³,14λ³-dioxa-15λ⁶-thia-1λ⁴,22-diaza-13-manganapentacyclo[11.9.0.0²,¹¹.0³,⁸.0¹⁶,²¹]docosa-1(22),2(11),3,5,7,9,16,18,20-nonaene-13,13-bis(ylium)-12,14-diide
Test material form:
solid: nanoform
Details on test material:
- Name of test material (as cited in study report): Litholechtscharlach 4290, C.I.Pigmentred 48:4, Monoazofarbstoff.
- 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): Litholechtscharlach 4290, C.I.Pigmentred 48:4, Monoazofarbstoff.
- Analytical purity: 100 %
- Physical state: solid

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 212 g, females 174 g

ENVIRONMENTAL CONDITIONS: not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
10% aqueous suspension
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: Due to technical reasons a higher concentration than 10% could not be applicated.
Doses:
1000 mg/kg bw and 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: 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 performed because it is not necessary.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Mortality:
No mortality observed.
Clinical signs:
other: Red feces.
Gross pathology:
No abnormalities observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met