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Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to chapter 13 for the read-across justification.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
12 Sept. 1973 to 03 Sept. 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
According to BASF-internal standard: 5 Sprague-Dawley rats (per sex and per dose) were exposed to the test substance via oral gavage at a dose of 5000 mg/kg bw. After an observation period of 7 days animals were necropsied and examined for clinical signs.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Name of the test substance used in the study report: Neozapongelb R (TDA) Chromium-1.2-complex

performed under old CAS 73297-13-9
new CAS 85029-58-9, same structure
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Mean body weight: males 176 g; females 166 g
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
Aqueous test substance preparation with CMC
Form of administration: suspension
Test concentration used: 16% (w/v)
Due to technical reasons, a higher test substance concentration (more than 16%) could not be administered.
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Feces brown coloured.
Gross pathology:
Nothing abnormal detected.
Interpretation of results:
GHS criteria not met
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
27 Feb. 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Name of test substance as cited in report: Neozapon-orange Vers. 1187 (pulvrig)
- Substance number as cited in report: 79-594

FORM AS APPLIED IN THE TEST
Suspension
Species:
rat
Strain:
Sprague-Dawley
Remarks:
Wiga
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males, 170-190 g; females: 160-170 g
- Fasting period before study: 15 to 20 hours
- Diet: Herilan MRH-Haltung; H Eggersmann KG
Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle (%, g/v): from low to high dose: 16.5; 24.2; 35.6; 35.6; 35.6
- Amount of vehicle (mL/kg): from low to high dose: 5.0; 5.0; 5.0; 7.3; 10.8

MAXIMUM DOSE VOLUME APPLIED:
10.8 mL/kg
Doses:
825; 1210; 1780; 2610; 3830 mg/kg
No. of animals per sex per dose:
5, except for the 2610 mg/kg dose in males which was tested in 4 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: < 15min, 15 min, 30 min, 1 hour, 4 hours, 1 day, 2 days, 5 days, 6 days, 7 days, 8 days, 9 days, 12 days, 13 days, 14 days
- Frequency of weighing: 2-4, 7 and 13 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 400 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
1 200 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
1 600 mg/kg bw
Based on:
test mat.
Mortality:
- 825 mg/kg: no mortality was observed
- 1210 mg/kg: males, 3 animals died after 7 days; females, 3 animals died after 7 days
- 1780 mg/kg: males, 1 animal died after 7 days; females, 4 animals died after 7 days
- 2610 mg/kg: males, 4 (all) animals died after 7 days; females, 5 (all) animals died after 7 days
- 3830 mg/kg: males, 5 (all) animals died after 7 days; females, 5 (all) animals died after 7 days
Clinical signs:
- 825 mg/kg: Observed symptoms included orange faeces, orange urine, diarrhoea
- 1210 mg/kg: Observed symptoms included orange faeces, orange urine, diarrhoea
- 1780 mg/kg: Observed symptoms included orange faeces, orange urine, diarrhoea
- 2610 mg/kg: Observed symptoms included orange faeces, orange urine, diarrhoea, dyspnoea, apathy, stagger, worse general condition
- 3830 mg/kg: Observed symptoms included orange urine, diarrhoea
Body weight:
No treatment-related effects observed
Gross pathology:
- Animals that died during the study: heart, acute dilation of the atria; acute hyperaemia; organs/adipose tissue/musculature: substance stained.
- Sacrificed animals: no effects observed
Interpretation of results:
Category 4 based on GHS criteria
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
5 May 1972 to 12 May 1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Principles of method if other than guideline:
Gassner rats were exposed to the test substance (5 animals/sex/dose) at dosages of 200, 2500, 3200, 4000, 5000, 6400, 8000 and 10000 mg/kg. After an observation period of 7 days surviving animals were sacrificed and pathological examination.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Name of test substance as cited in report: Neozaponorange RE (60-2819)
Species:
rat
Strain:
other: Gassner
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: Males, on average 244 g; females, on average 175 g
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Application form: 30% aqueous suspension with carboxymethyl cellulose
Doses:
PRETEST
3200 and 6400 mg/kg

MAIN TEST
2000, 2500, 3200, 4000, 5000, 6400, 8000 and 10000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
PRETESTS
- Duration of observation period following administration: 14 days

MAINTEST
- Duration of observation period following administration: 7 days
- Frequency of observations: 1 hour, 1 day, 2 days, 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, (histo)pathology
Preliminary study:
MORTALITY
- 3200 mg/kg: 0/5 males and 2/5 females died
- 6400 mg/kg: 3/5 males and 5/5 females died
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 500 mg/kg bw
Based on:
test mat.
Mortality:
- 2000 mg/kg: no mortality observed
- 2500 mg/kg: no mortality observed
- 3200 mg/kg: no mortality observed
- 4000 mg/kg: male: 1/5 at 7 days; no mortality among females
- 5000 mg/kg: no mortality among males; female: 3/5 at 7 days
- 6400 mg/kg: male: 1/5 at 2 days, 4/5 at 7 days; female, 1/5 at 2 days, 5/5 at 7 days
- 8000 mg/kg: male: 1/5 at 2 days, 5/5 at 7 days; female, 1/5 at 2 days, 5/5 at 7 days
- 10000 mg/kg: male: 1/5 at 2 days, 5/5 at 7 days; female, 1/5 at 2 days, 5/5 at 7 days
Clinical signs:
All treated animals showed immediately after application chewing movements and crouched after approximately 4 hours. From 4 days irregular breathing, orange colouring of the fur, eyes, ears, arms, legs, faeces and urine were observed. The animals from the 5000 and 6400 mg/kg group were without symptoms from day 7, the animals from the 2000 to 4000 mg/kg group were without symptoms from day 5.
Gross pathology:
- Animals that died during the study: Finding included acute dilution of both heart chambers; general congestion hyperaemia; thin, pulpy and red-brown/orange stained stomach contents; diarrheal reddish contents in the intestines (containing blood in one case); red/orange coloured musculature and adipose tissue, very thin appearance and bloody erosions in the glandular stomach area.
- Animals that were sacrificed at the end of the study: Organs were slightly reddish coloured.
Interpretation of results:
GHS criteria not met

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of Amines, C10-14-branched and linear alkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-) (1:1) and Amines, C10-14-branched and linear alkyl, bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-) and Amines, C10-14-branched and linear alkyl, [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)
EC Number:
943-133-8
Molecular formula:
C32H22CrN10O8.C10-14H21-29NH2 / C34H24CrN8O6.C10-14H21-29NH2 / C33H23CrN9O7.C10-14H21-29NH2
IUPAC Name:
Reaction mass of Amines, C10-14-branched and linear alkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-) (1:1) and Amines, C10-14-branched and linear alkyl, bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-) and Amines, C10-14-branched and linear alkyl, [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)
Test material form:
solid

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
1 200 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Result read-across source CAS No. 84961-40-0
Remarks:
Correction for molecular weight not necessary.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 400 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Result read-across source CAS No. 84961-40-0
Remarks:
Correction for molecular weight not necessary.
Sex:
male
Dose descriptor:
LD50
Effect level:
1 600 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Result read-across source CAS No. 84961-40-0
Remarks:
Correction for molecular weight not necessary.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Result read-across source CAS No. 85029-58-9
Remarks:
Correction for molecular weight not necessary.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Result read-across source CAS No. 84961-59-0
Remarks:
Correction for molecular weight not necessary.

Applicant's summary and conclusion