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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Principles of method if other than guideline:
Acute toxicity upon intraperitoneal injection in mice with 7 day observation period.
GLP compliance:
no
Limit test:
no

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:
- Physical state: solid
- Name of test material (as cited in study report): Litholechtscharlach 4300, C.I.Pigmentred 48:4, 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): Litholechtscharlach 4300, C.I.Pigmentred 48:4, Monoazofarbstoff.
- Analytical purity: 100 %

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
aqueous suspension
Details on exposure:
The concentration in the suspenstion was not the same for all dose groups. Volume applied was 10 ccm per kg bw
Doses:
3000, 1600, 800 and 200 µg/kg bw
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 1 400 mg/kg bw
Based on:
test mat.
Mortality:
At 3000 mg/kg bw, mortality occured within 1 day after dosing. At 1600 mg/kg bw, it occured within 3 days after dosing.
Clinical signs:
Dyspnea, spastic gait, atony; Symptoms occured immediately after dosing. Surviving animals recovered within 6 days.
Gross pathology:
Precipitates of the substance were found in the abdomen. The liver was clay coloured at the top dose.

Applicant's summary and conclusion