Evernia furfuracea, ext.

Endpoint summary

Description of key information

Acute toxicity, oral in rats: LD50 = 5020 mg/kg bw (read-across from treemoss concrete, equivalent or similar to OECD 401, non-GLP, K, Rel. 2)

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:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

Mice were given a single oral dose of test substance up to 5 mL/kg bw and then observed for 14 days.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Name of test material: TRNO-25

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

4, 4.5 and 5 mL/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed for mortality and clinical signs at least daily for 14 days

Preliminary study:

Not applicable

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

4.33 mL/kg bw

Based on:

test mat.

95% CL:

>= 4.01 - <= 4.68

Mortality:

3/10 at 4 mL/kg bw
5/10 at 4.5 mL/kg bw
9/10 at 5 mL/kg bw

Clinical signs:

No data

Body weight:

No data

Gross pathology:

No data

Other findings:

None

None

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the test conditions, oral LD50 of test substance is 4.85 g/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 and classified category 5 (H303) according to GHS.

Executive summary:

In an acute oral toxicity study, 10 rats/dose were given a single oral dose of test item at 4, 4.5 and 5 mL/kg bw. Animals were then observed for mortality and clinical signs at least daily for 14 days.

3/10, 5/10 and 9/10 deads were observed at 4 mL/kg bw, 4.5 mL/kg bw and 5 mL/kg bw, respectively. The calculated LD50 was 4.33 mL/kg bw with 90% confidence limits of 4.01-4.68 mL/kg bw, corresponding to 4.85 g/kg bw and 90% confidence limits of 4.52-5.28 g/kg bw with a density of 1.1278.

 

Under the test conditions, oral LD50 of test substance is 4.85 g/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 and classified category 5 (H303) according to GHS.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

5 020 mg/kg bw

Quality of whole database:

Adequate for hazard assessment

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

Acute toxicity: via oral route

In an acute oral toxicity study, 10 rats/dose were given a single oral dose of test item at 4, 4.5 and 5 mL/kg bw. Animals were then observed for mortality and clinical signs at least daily for 14 days.

3/10, 5/10 and 9/10 deads were observed at 4 mL/kg bw, 4.5 mL/kg bw and 5 mL/kg bw, respectively. The calculated LD50 was 4.33 mL/kg bw with 90% confidence limits of 4.01-4.68 mL/kg bw, corresponding to 5.02 g/kg bw and 90% confidence limits of 4.65-5.43 g/kg bw with a density of 1.1595.

 

Under the test conditions, oral LD50 of test substance is 5.02 g/kg bw therefore target substance is not classified according to the Regulation (EC) N° 1272-2008 and classified category 5 (H303) according to GHS because the low limit of the 95% confidence interval is below 5 g/kg bw.

Justification for classification or non-classification

Harmonized classification:

The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Acute toxicity via Oral route:

Based on the available information, the registered substance is:

- not classified according to the Regulation (EC) No. 1272/2008 and classified category 5 (H303) according to GHS because the low limit of the 95% confidence interval of the LD50 is below 5 g/kg bw.

Acute toxicity via Dermal route:This information is not available

Acute toxicity via Inhalation:This information is not available.

Specific target organ toxicity: single exposure (Oral):

The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C ≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw ≥ C > 300 mg/kg bw). No classification is required.

Specific target organ toxicity: single exposure (Dermal): This information is not available

Specific target organ toxicity: single exposure (Inhalation): This information is not available.

Based on its physical state, the registered substance is not classified for aspiration hazard.