p-anisic acid

Endpoint summary

Description of key information

Oral (equivalent or similar to OECD 401), rat: LD50 > 5000 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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

The study was conducted before a guideline was adopted.

Principles of method if other than guideline:

Two groups of male rats (n = 10) received a single treatment of 3100 or 5000 mg/kg bw orally by gavage. Animals were observed for 14 days after treatment. Mortalities and clinical signs were recorded.

GLP compliance:

no

Remarks:

study performed before implementation of GLP

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation: 160 - 180 g
- Housing: 5 animals/cage

Route of administration:

oral: gavage

Vehicle:

peanut oil

Doses:

3100 and 5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

At 5000 mg/kg bw two animals died on day 4. No mortalities occurred at 3100 mg/kg bw.

Clinical signs:

other: At 5000 mg/kg all animals showed clinical signs (diarhoea and increased diuresis). No clinical signs were noted at 3100 mg/kg bw.

Gross pathology:

no data available

Interpretation of results:

GHS criteria not met

Conclusions:

In this study conducted prior to implementation of current guidelines in male rats an LD50 of > 5000 mg/kg bw was derived.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

The available information comprises an adequate and reliable study (Klimisch score 2), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

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

A reliable study regarding acute oral toxicity is available for the test substance. The acute oral toxicity of the test substance was assessed in a study performed equivalent or similar to OECD Guideline 401 (Bayer, 1979). Two groups of 10 male Wistar rats were treated with the test material at dose levels of 3100 and 5000 mg/kg bw. The test material was administered by gavage using peanut oil as vehicle. The animals were observed for 14 days. At the high dose two animals died on day 4 and all animals showed clinical signs of toxicity (diarhoea and increased diuresis). Neither mortalities nor clinical signs were noted at 3100 mg/kg bw.

The acute oral LD50 value of the test material was therefore > 5000 mg/kg bw.

Justification for classification or non-classification

The available data on acute toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.