Reaction products of diazotized 2-amino-4-(methylsulfonyl)-phenol with 2-(3-Chlorophenyl)-2,4-dihydro-5-methyl-3H-pyrazol-3-one and Methyl-7-hydroxy-1-naphthylcarbamate – and chromium (III) 2:1, salted by ammonium, sodium and acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions. Observation period was 8 instead of 14 days. No information about test substance purity was given.

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)

Version / remarks:

(adopted 1981)

Deviations:

yes

Remarks:

Observation period: 8 instead of 14 days.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Orasol Brown 2GL

IUPAC Name:

Orasol Brown 2GL

Details on test material:

Purity: no data.

Test animals

Species:

rat

Strain:

other: RAI (outbred, SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: "young", no further data
- Weight at study initiation: 111-139 g
- Fasting period before study: fasted overnight.
- Housing: groups of 5 in Makrolon cages.
- Diet (ad libitum): standard diet of Nafag.
- Water (ad libitum): drinking water.
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 1
- Humidity (%): 55+/- 5
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5% in tap water

Details on oral exposure:

VEHICLE
- Concentration in vehicle (% in 0.5% CMC in tap water)
500 mg/kg bw: 2.5%
1000 mg/kg bw: 5%
3000mg/kg bw: 15%
5000 mg/kg bw: 25%
10000 mg/kg bw: 50%

Doses:

500, 1000, 3000, 5000, 10000 mg/kg bw

No. of animals per sex per dose:

5 (highest dose group: 3 male, 2 female)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 8 days
- Frequency of observations and weighing: before treatment and at day 8.
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, body weight

Statistics:

The LD50 was calculated by the method of Miller-Tainter (Proc. Soc. Exp. Biol. Med. 57, 261, 1944).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 350 mg/kg bw

Based on:

test mat.

95% CL:

2 167 - 4 537

Remarks on result:

other: No mortalities in the 2 lowest dose groups, while all animals died in the high dose group. Treatment with 3000 mg/kg bw led to the death of 2 males and 3 females, while treatment with 5000 mg/kg bw led to 3 males and 5 females.

Mortality:

500, 1000 mg/kg bw: no mortality.
3000 mg/kg bw: 2/5 male, 3/5 female. (death occured at day 2,3)
5000 mg/kg bw: 3/5 male, 5/5 female. (death occured at day 3,5,7,8)
10000 mg/kg bw: 3/3 male, 2/2 female. (death occured at day 4,6,8)

Clinical signs:

other: 3000 mg/kg bw: ataxia, sedation, piloerection 5000 mg/kg bw: ataxia, sedation, piloerection, diarrhoea 10000 mg/kg bw: ataxia, sedation, piloerection, diarrhoea, ventricumbency, muscular weakness

Other findings:

All test groups: brown stained feces.

Any other information on results incl. tables

In an acute toxicity study 5 RAI rats per sex and per dose were treated (oral, gavage) with 500, 1000, 3000, 5000, 10000 mg test substance/kg bw. In the two lowest dose groups no mortality occured. After treatment with 3000 mg/kg 2/5 male and 3/5 females died, while treatment with 5000 mg/kg bw led to 3/5 male and 5/5 female deaths. In the high dose group all animals died within 8 days after treatment. The LD50 was deduced to be 3350 mg/kg bw. Similar clinical signs were seen in dose groups from 3000 mg/kg bw on, that were ataxia, sedation, piloerection. In addition diarrhoea was observed in the 5000 and 10000 mg/kg bw group. Ventricumbency and muscular weakness was observed in the high dose group.