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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1984-08-08 - 1984-12-18
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non GLP, scientifically acceptable study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Objective of study:
excretion
Test guideline
Qualifier:
no guideline followed
GLP compliance:
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
Radiolabelling:
no

Test animals

Species:
rat
Strain:
other: Til:RAI f SPE
Sex:
male
Details on test animals or test system and environmental conditions:
ENVIRONMENTAL CONDITIONS
- Temperature: 21 +/- 1 °C
- Humidity: 65 % +/- 5 %

Administration / exposure

Route of administration:
oral: gavage
Duration and frequency of treatment / exposure:
single treatment
Doses / concentrations
Remarks:
Doses / Concentrations:
1 m³ of the formulation per animal corresponding to 33.17 mg/animal of the test substance
No. of animals per sex per dose / concentration:
4 rats divided into two groups
Control animals:
yes
Details on study design:
rats received a single oral dose of 33.7 mg/animal of the test item and 10.0 mg/animal of β-naphthylamine. The residues of β-naphthylamine in urine of rats were measured after 24 hours and 48 hours.
Details on dosing and sampling:
PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine
- Time and frequency of sampling: 24h, 72h


Statistics:
none

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on excretion:
No residues of β-naphthylamine (<0.06 mg/dm3) were found in urine of rats within 48 hours after a single oral treatment with the test substance at a dose of 33.17 mg/animal. After a single oral treatment with β-naphthylamine at a dose of 10 mg/animal, residues of β-naphthylamine were found to range between 3.5 and 5.1 mg/dm3 in the 0-24 hours samples and to decrease to 0.14-0.24 mg/dm3 in the 24-48 hours samples.

Any other information on results incl. tables

Residues of  β-naphthylamine in urine of rats after treatment with β-naphthylamine and with the test substance

Test substance

Animal No.

Animal weight g

Application dosis mg/animal

β-naphtylamine mg/dm3

0-24h

24-48h

β-naphthylamine

              84185

plus      84186

201.4

199.2

10.0

10.0

3.5

0.14

              84187

plus      84188

210.4

201.2

10.0

10.0

5.1

0.24

Test substance

              84177

plus      84178

205.7

199.4

33.17

33.17

<0.06

<0.06

              84179

plus      84180

198.4

203.8

33.17

33.17

<0.06

<0.06

Control

              84189

plus      84190

197.3

208.4

-

-

<0.06

<0.06

              84191

194.4

-

<0.06

<0.06

Applicant's summary and conclusion