Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Manganese, 3-hydroxy-4-[(1-sulfo-2-naphthalenyl)azo]-2-naphthalenecarboxylic acid complex
EC Number:
252-525-1
EC Name:
Manganese, 3-hydroxy-4-[(1-sulfo-2-naphthalenyl)azo]-2-naphthalenecarboxylic acid complex
Cas Number:
35355-77-2
Molecular formula:
C21H12MnN2O6S
IUPAC Name:
manganese(2+) hydrogen 3-oxido-4-[(E)-(1-sulfonatonaphthalen-2-yl)diazenyl]naphthalene-2-carboxylate

Test animals

Species:
rat
Strain:
other: Tif:RAI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 6 and 7 weeks old
- Weight at study initiation: 160 to 180 g
- Fasting period before study: one night before starting the treatment
- Housing: the animals were segregated and housed in Macrolon cages in groups of 5.
- Diet: The animals received water and food ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 50 %

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
- Concentration used: 30% (w/v)
Doses:
4640, 6000 mg/kg bw (no higher doses were possible)
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured
Clinical signs:
Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The animals had recovered wihtin 5 days.
Body weight:
no data
Gross pathology:
No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 of the test substance in rats of both sexes observed over a period of 7 days is greater than 6000 mg/kg.
Executive summary:

Groups of twenty, 6 to 7 weeks old Tif. RAI rats (10/sex) were given a single oral dose of the test substance in carboxymethyl cellulose (CMR) at doses of 4640 and 6000 mg/kg bw (no higher doses were possible) and observed for 7 days. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The animals had recovered within 5 days and no death occured at any dosage levels used. The acute oral LD50 of the test substance after a single oral administration to rats is greater than 6000 mg/kg bw.