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-)

Acute Toxicity: oral

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-reference

Cross-reference 1

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:

other: Feces brown coloured.

Gross pathology:

Nothing abnormal detected.

Interpretation of results:

GHS criteria not met

Cross-reference 2

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:

other: - 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:

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

Cross-reference 3

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:

other: 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

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

Materials and methods

Test material

Test material information

Constituent 1

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 levels

Effect levels 1

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.

Effect levels 2

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.

Effect levels 3

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.

Effect levels 4

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.

Effect levels 5

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.