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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
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:
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

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