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Description of key information

LD50 (male and female) > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From July 20 to August 04, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen.
- Females nulliparous and non-pregnant: yes.
- Age at study initiation: 8 weeks for male, 9 - 10 weeks for female.
- Weight at study initiation: average 199 g for male and average 173 g for female.
- Housing: conventional Makrolon cages, type III
- Fasting period before study: ca 16 hours before and 4 hours after dosing.
- Diet: standard diet "fixed-formula" Altromin 1324 Pellets, ad libitum.
- Water: libitum.
- Acclimation period: 5 days adaptation.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 5 %
- Photoperiod: 12 hrs dark / 12 hrs light.
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
- Volume of administration: 10 mg/kg bw
- Preparation: test substance was formulated in the application medium immediately before the treatment.
- Administration: first animals of a gender (male) were treated with the intended dose. As soon as it could be seen that the dose did not result in a high lethality, the female animals were treated to determine any gender differences.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: on the day of application (day 1), animals were examined several times daily; once on weekends and public holidays in the following 14-day observation period, recording the type, beginning, duration and intensity of the clinical symptoms as well as possible dead animals away.
- Frequency of weighing: immediately before application (day 1), after one week and at the end of the 14-day observation period the animals were individually weighed. The individual application volume was calculated by means of the body weight obtained immediately before the application.
- Necropsy of survivors performed: yes.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
No poisoning phenomena were observed during the 14-day observation time. Eight hours up to a day after the administration of test substance, blue discolouration of faeces was seen.
Body weight:
The growth was not influenced in male and female rats.
Gross pathology:
No abnormalities were observed.
Interpretation of results:
other: not classified, according to the CLP Regulation (EC) No 1272/2008
Conclusions:
LD50 (male and female) > 2000 mg/kg bw
Executive summary:

Oral acute toxicity potential of test material was tested in rats, following procedures outlined in OECD guideline 401. A single dose of 2000 mg/kg bw was administered by gavage. Animales were observed for 14 days after dosing.

No death occurred during the main test and no poisoning phenomena were observed during the 14-day observation time. Eight hours up to a day after administration of test substance, blue discolouration of faeces was reported. No abnormalities were revealed by necropsy.

Conclusion

LD50 (male and female) > 2000 mg/kg bw

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

ORAL ACUTE TOXICITY

The oral acute toxicity potential of Acid Blue 193 was tested in rats, following the procedures outlined in OECD guideline 401. No death occurred during the main test and no poisoning phenomena were observed during the 14-day observation time. Eight hours up to a day after the administration of the tested substance a corresponding blue color of the dye administered was found in the faeces. No abnormalities were revealed by necropsy.

A second test is available on the substance for oral acute toxicity potential. Only limited details on the tested substance are available, thus a reliability cannot be assigned.

Also in this case, the study was based on recommendations of OECD guideline 401. Based on the mortality data recorded in the preliminary test, the main experiment was conducted at the dose level of 2000 mg/kg. No death occurred during the main test.

The following findings were noted: hunched posture, lethargy and pilo-erection in all animals on the day of dosing and on day one. Staining of the fur was also apparent in all animals during this period. In addition, all animals showed decreased respiratory rate, diahorrea and tiptoe gait at the 4-hour observation. Occasional signs of ataxia and ptosis were also noted at this time. AlI animals recovered and appeared normal on day 2 and throughout the remainder of the study period. Normal bodyweight gains were recorded for all animals during the study period.

All animals were necropsied on day 14. Occasional abnormalities wene noted in the kidneys and lungs. A mottled, green abnormal appearance was noted in the kidneys of one male and three females. Congestion of the lungs was noted in three males and one female.

Therefore, the LD50 was stated to be greater than 2000 mg/kg, confirming the main experimetn study outcomes.

In addition, an old sheet of testing results is available. No details about testing method and procedures are included into the document available, thus a reliability cannot be evaluated. The test item was administrated to rats as a suspension: 2-30 % aqueous solution. Clinical signs recorded were dyspnea, diahorrea, blue color of the coat. Acute heart dilatation especially on the right, dilated stomach, organs stained were indicated as macroscipical effects observed during gross pathology examination. The LD50 was indicated to be 5600 mg/kg bw.

DERMAL ACUTE TOXICTY

Data from a sheet of testing results are available on the acute dermal toxicity potential of Acid Blue 193. However, no details about testing method and procedures are included into the document available, therefore the reliability of data cannot be evaluatedn and study results have not been taken into consideration from the classification point of view; the study is here included only for completeness sake.

The test item was administrated to rats as a suspension of 50 % aqueous solution. Neither clinical signs, either gross pathology effects were recorded. The LD50 was indicated to be higher than 2500 mg/kg bw.

Justification for classification or non-classification

According to the CLP Regulation (EC) No 1272/2008, 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

The oral LD50 value was established to be greater than 2000 mg/kg body weight, therefore test substance is above the threshold for classification for acute oral toxicity (oral acute toxicity category 4: 300 < ATE ≤ 2000 mg/kg bw).