3-pyridylmethanol

Endpoint summary

Description of key information

Acute oral toxicity:

The LD50 value of the test item was determined to be higher than 2000 mg/kg after single oral administration in female rats.

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:

5 May 2017 - 6 September 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2001

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI (Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 9 weeks
- Weight at study initiation: 155 - 183 g
- Housing: individually in type III Makrolon*1 cages with a shelter on softwood bedding material and a play tunnel
- Diet: ad libitum, V1534, ssniff Spezialdiaten GmbH, Germany)
- Water, ad libitum, community water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.8 - 23.3
- Humidity (%): 38.1 - 78.6

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

CLASS METHOD
- Rationale for the selection of the starting dose: existing information concerning the toxic potential of pyridine (Smyth, 1951 and Anderson, 1987)

Doses:

300 mg/kg bw and 2000 mg/kg bw

No. of animals per sex per dose:

300 mg/kg bw: 2 x 3
2000 mg/kg bw: 6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations once daily, weighing on day 1 (before treatment), 2, 4, 6, 8, 11, 13 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, pathology

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was seen.

Clinical signs:

All rats treated with 2000 mg/kg bw showed locomotor disturbance and piloerection on day 1 which started 2 hours after treatment.

Body weight:

There were no effects on the body weight development throughout the study.

Gross pathology:

No organ alterations were identified during the gross pathological examination.

Other findings:

No other findings.

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 value of the test item was determined to be higher than 2000 mg/kg bw after single oral administration in female rats.

Executive summary:

The objective of the study according to OECD guidline 423 was to identify potential toxic effects of the test item after single oral administration to rats in a stepwise procedure. The study was started with 300 mg/kg bw in 3 female rats, continued with further 3 females treated with 300 mg/kg bw. Due to the fact, that no mortality was seen after treatment with 300 mg/kg bw, 6 further females were treated with 2000 mg/kg bw. Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy. 

No mortality occurred during the course of this study. All rats treated with 2000 mg/kg bw showed locomotor disturbance and piloerection on day 1 which started 2 hours after treatment. The body weight development was inconspicuous throughout the study.The gross pathological examination revealed no organ alterations. The LD50 value of the test item was determined to be higher than 2000 mg/kg bw after single oral administration in female rats.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 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

Acute oral toxicity:

The objective of the study according to OECD guidline 423 was to identify potential toxic effects of the test item after single oral administration to rats in a stepwise procedure. The study was started with 300 mg/kg in 3 female rats, continued with further 3 females treated with 300 mg/kg. Due to the fact, that no mortality was seen after treatment with 300 mg/kg, 6 further females were treated with 2000 mg/kg. Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy. 

No mortality occurred during the course of this study. All rats treated with 2000 mg/kg showed locomotor disturbance and piloerection on day 1 which started 2 hours after treatment. The body weight development was inconspicuous throughout the study.The gross pathological examination revealed no organ alterations. The LD50 value of the test item was determined to be higher than 2000 mg/kg after single oral administration in female rats.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Based on this data, the substance is not considered not to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EC) No 2017/776.