[No public or meaningful name is available]

Endpoint summary

Description of key information

Acute toxicity, oral route: LD₅₀ > 2000 mg/kg bw.

Acute Toxicity, other routes - Intraperitoneal route: LD₅₀ > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

April 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Justification for type of information:

Source study has a Klimisch Score = 2.
For further information see the read across justification attached in section 13.

Principles of method if other than guideline:

Acute toxicity in rats assessed in a limit test at dose of 2000 mg/kg by oral route. Observations were continued for up to 14 days.

GLP compliance:

no

Test type:

standard acute 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: Bantin and Kingman Ltd.
- Weight at study initiation: 195 - 300 g
- Fasting period before study: 18 - 20 h before treatment
- Housing: in groups of 5 by sex
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity: 50 ± 10%
- Photoperiod: natural lighting conditions

Route of administration:

oral: gavage

Vehicle:

water

Doses:

2000 mg/kg bw based on the individual fasted body weight of the animals at the time of treatment.

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: observations for overt toxicity and mortality at 15 min, 1, 2 and 4 hours after treatment and subsequently once daily for 14 days; body weights of survivors at 7 and 14 days after treatment.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: no signs of overt toxicity.

Interpretation of results:

GHS criteria not met

Conclusions:

LD0 = 2000 mg/kg bw - LD50 > 2000 mg/kg bw

Executive summary:

Method:

Test substance was administered to 5/rat/sex by gavage at dose of 2000 mg/kg bw. Test animals were observed for 14 days after dosing.

Results:

No mortality was recorded, thus LD₀ = 2000 mg/kg bw. and LD₅₀ > 2000 mg/kg bw.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

November 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Justification for type of information:

Source study has a Klimisch Score = 2.
For further information see the read across justification attached in section 13.

Principles of method if other than guideline:

Acute toxicity in rats assessed in limit test at dose of 5000 mg/kg by oral route. Observations were continued for up to 14 days.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5 % in water

Details on oral exposure:

Concentration in vehicle: 50 % m/v
Maximum volume applied: 10 ml/kg

Doses:

5000 mg/kg

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

Duration of observation period following administration: 14 days

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Brown urine

Interpretation of results:

GHS criteria not met

Conclusions:

LD0 = 5000 mg/kg bw - LD50 > 5000 mg/kg bw

Executive summary:

Method:

Test substance was administered to 5/rat/sex by gavage at dose of 5000 mg/kg bw. Test animals were observed for 14 days after dosing.

Results:

No mortality was recorded, thus LD₀ = 5000 mg/kg bw and LD₅₀ > 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as LD₅₀ (oral, dermal) or LC₅₀ (inhalation) values as well as acute toxicity estimates (ATE).

According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:

For acute toxicity, oral route:

• Category 1: ATE <= 5 mg/kg bw


• Category 2: 5 < ATE <= 50 mg/kg bw


• Category 3: 50 < ATE <= 300 mg/kg bw


• Category 4: 300 < ATE <= 2000 mg/kg bw

The LD₅₀ of the test substance was determined to be > 2000 mg/kg bw. in the chosen reference test, which is outside the above criteria. Therefore, the test substance is not classified for acute toxicity by oral exposure.

Oral LD₅₀ above 2500 mg/kg bw was found, thus target substance was not classified for acute oral toxicity in the CLP Regulation (EC n. 1272/2008).