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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972
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:
1972
Report date:
1972

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:
Amines, C10-14-branched and linear alkyl, bis[2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-)
EC Number:
285-082-8
EC Name:
Amines, C10-14-branched and linear alkyl, bis[2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-)
Cas Number:
85029-57-8
Molecular formula:
C32H22CrN10O8.C10-14H21-29NH2
IUPAC Name:
Amines, C10-14-branched and linear alkyl, bis[2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-)
Specific details on test material used for the study:
Name as cited in study report: Neozaponrot BE
Substance number as cited in study report: 53-055R
Appearance: the substance is deep purple
FORM AS APPLIED IN THE TEST: watery suspension (30%)

Test animals

Species:
rat
Strain:
other: Gassner
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 243 g (M) and 192 g (F)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30% suspension

MAXIMUM DOSE VOLUME APPLIED:
33.3 mL /kg

Doses:
8000 and 10000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1 hour, 24 hours, 48 hours, 7 days and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Mortality:
No mortality observed during the 14 day observation period
Clinical signs:
other: Fast breathing during the first 3 hours after application
Gross pathology:
8000 mg/kg bw: Mild red staining of organs and in 3 animals parasital infection of the caecum (oxyuren)
10000 mg/kg bw: Mild red staining of organs and in 2 animals parasital infection of the caecum (oxyuren)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met