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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:
1984
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:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Acid Black 076
IUPAC Name:
Acid Black 076
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Han
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: KFM, 4414 Fullinsdorf, CH
- Age at study initiation: young adult
- Weight at study initiation: 160 to 205 g
- Fasting period before study: access of food only was prevented from approximately 18 hours prior and four hours after the dosingl water bottles were withdrawn two hours prior and four hours after dosing
- Housing: individually in Macrolon cages
- Diet: standard laboratory pelleted diet (KLIBA no. 24-343-4 from Klingentalmuhle AG., Basle); ad libitum.
- Water: ad libitum
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 2 °C
- Humidity: 30 to 70 %
- Air changes: 15 air changes/hour.
- Photoperiod: 12 hours cycle dark/light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
20 ml/kg bw
Doses:
10000 mg/kg bw
No. of animals per sex per dose:
- Preliminary study: two animals per sex per dose
- Main study: five animals per sex per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: animals were monitored for clinical signs and mortality soon after dosing, then at hourly intervals for the remainder of day 1; on the subsequent days the animals were observed once in the morning and once in the late afternoon
- Frequency of weighing: individual body weights on days 1, 7 and 14
- Necropsy of survivors performed: yes, surviving animals were killed after two weeks
- Other examinations performed: all animals which died during the study and those killed after two weeks were subjected to a macroscopic postmortem examination; the macroscopic appearance of the abnormal organs was recorded.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
Preliminary test: no mortality observed
Main test: one male rat and three female rats
Clinical signs:
The animals were flaccid, weak and showed decreased movement, exophthalamus, rough coat, gasping labored and decreased respiration, and diarrhea.
Body weight:
See Table 2: Results of the main study, in "Any other information on results", below.
Gross pathology:
No special findings

Any other information on results incl. tables

Table 1: Results of the preliminary study.

Dose (mg/kg) Mortality ratio (no. deaths/no. dosed) Time of death after dosing
males females combined
10000 0/2 0/2 0/4 -

Table 2: Results of the main study.

Sex Dose (mg/kg) Body weight (g) at Mortality ratio (no. deaths/no. dosed) Time of death after dosing (hours)
dosing 1 week 2 weeks
M 10000 163.0 183.4 235.0 1/5 26
F 10000 198.0 207.5 220.0 3/5 5, 5, 14

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC) no. 1272/2008
Conclusions:
The LD50 for oral administration of the test item was found to exceed 10000 mg/kg body weight.
Executive summary:

The acute oral toxicity of the test item was evaluated in an experimental study equivalent to the OECD Guideline 401 (1987). A preliminary study was carried out to establish a dosing regimen: two male and two female Wistar rats were administered 10,000 mg test item/kg bw and monitored for mortality. In the main study, five male and five female Wistar rats were administered 10,000 mg test item/kg bw by oral gavage. Clinical symptoms and mortality were monitored after administration for an observation period of 14 days, thereafter all animals were submitted to necropsy and macroscopic examination.

No mortality was observed among animals in the preliminary study. In the main study, 1 male and 3 females died before the end of the observation period. The male mortality occurred 26 hours after dosing; the female mortalities occurred 5, 5 and 14 hours after dosing. Mean body weights of surviving males and females increased throughout the observation period. The LD50 of the test item was found to exceed 10000 mg test item/kg body weight.