CA SL66

Endpoint summary

Description of key information

LD50 oral acute rat > 1500 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:

other: read across from supporting substance

Adequacy of study:

key study

Study period:

April 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: First attachments of 30 July 1996 DIRECTIVE 96/54/EC (L 248)

Deviations:

no

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: authorized vendor
- Weight at study initiation: 175 ± 5 g
- Housing: Makrolon cage (48 x 27 x 20 cm), with bedding of wood chips.
- Diet: free access to an experimental diet for rats, provided by an accredited supplier.
- Water: tap water bottles ad libitum
- Acclimation period: 7 days
- Health check: during acclimatation period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C (± 2°C).
- Humidity (%): 55% (± 25%)
- Air changes (per hr): 15 air change per hour with filtered air (5 µm)
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg for 20 ml of water
- Amount of vehicle : 2 ml of solution for 100 mg of body weight

Doses:

2000, 200, and 25 mg/Kg bw

No. of animals per sex per dose:

3 animals per each sex per dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed:
Skin, hair, eyes, mucous membranes, respiratory, circulatory system, central and autonomic nervous system, somatomotor activity and behavior patterns. Particular attention to: tremors, convulsions, salivation, diarrhea, lethargy, sleep and coma.

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 1 500 mL/kg bw

Based on:

act. ingr.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 500 mg/kg bw

Based on:

act. ingr.

Mortality:

no mortality observed

Clinical signs:

no clinical signs observed

Body weight:

no body weight lost

Gross pathology:

no patology observed after necropsy

sacrifice:

All survived animals are killed by CO2 administration

The test was conducted as a limit test, since no mortality was recorded, no further test or analysis are necessary

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance was tested with a limit test method and acute oral toxicity for rats is LD50 > 1500 mg/kg bw based on active ingredient

Executive summary:

The substance was tested for acute toxicity on Wistar rats. No signs of toxicity are observed during the experiment at dose of 2000 mg/kg bw. The substance is not toxic for oral administration.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

1 500 mg/kg bw

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 exposure pattern is covered by one study on the similar substance 1.

Despite the oral toxicity has been performed just as a limit test at 2000 mg/Kg bw and the purity of the sample is about 75%, the fact that no effects at 1500 mg/Kg bw of active material has been observed it can be concluded that the substance doesn't arise any concern for acute toxicity .

Based on Read Across with similar substance 1, also Acid Brown 348 can be considered as non toxic for acute oral toxicity.

Read across is discussed more in detail in the read across document in section 13

Justification for selection of acute toxicity – oral endpoint

The study is well described

Justification for classification or non-classification

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 shown in Table 3.1.1 of CLP Regulation. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE). The limit value that can trigger to Classification is 2000 mg/Kg for oral and dermal exposure pattern and 5 mg/l for inhalation exposure pattern. Based on the consideration in the discussion above, no classification for acute toxicity oral is warranted under Regulation 1272/2008