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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
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

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.

Applicant's summary and conclusion