Essential oil of Myroxylon balsamum var. pereirae (Fabaceae) obtained from the exudate by dry distillation

Endpoint summary

Description of key information

In an acute oral toxicity study on rats, the Oral LD50 was found to be superior to 5 mL/kg. (pre- GLP, Rel. K2)

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:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Pre-GLP study performed similar to OECD Guideline 401 with minor deviations: no data on source of animals and environmental conditions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no data on source of animals and environmental conditions

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

pre-GLP

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Used as supplied

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 118-137 g
- Fasting period before study: Overnight
- Housing: Animals were housed in groups of five males or five females in suspended stainless steel wire mesh cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

None

Doses:

5 mL/kg bw

No. of animals per sex per dose:

Five

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for toxic symptoms and mortality were made at ½, 1, 2, 4 and 24 hours, and then daily for 14 days after dosing. Animals were weighed initially and at 14 days.
- Necropsy of survivors performed: Yes; gross pathological examination was performed for all animals.

Statistics:

No data

Preliminary study:

Not applicable

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Mortality:

Only 1 male died within a 48-hour period.

Clinical signs:

Toxic symptoms consisted of slight salivation, slight ataxia, slight respiratory depression and a slight decrease in spontaneous activity started 1 hour after dosing and persisted through 4 hours. By 24 hours, all animals appeared normal except one male which was unconscious and died within 48 hours.

Body weight:

Mean body weight gains in females and males were 44 and 88 g, respectively.

Gross pathology:

No gross pathological changes were noted upon necropsy.

Other findings:

None

None

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the oral LD50 of the test substance is >5 mL/kg bw in rats. Therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the Globally Harmonised System of classification and labelling of chemicals (GHS). No signal word or hazard statement is required.

Executive summary:

In an acute oral toxicity study performed similar to the OECD Guideline 401, a single dose of 5 mL/kg bw of undiluted test substance was given by oral gavage to a group of 5 male and 5 female Sprague Dawley rats. Animals were then observed for mortality, clinical signs and body weight changes for 14 days, and were all sacrificed for macroscopic examinations.

Only 1 male died within a 48-hour period. Toxic symptoms consisted of slight salivation, slight ataxia, slight respiratory depression and a slight decrease in spontaneous activity started 1 hour after dosing and persisted through 4 hours. By 24 hours, all animals appeared normal except one male which was unconscious and died. Mean body weight gains in females and males were 44 and 88 g, respectively. No gross pathological changes were noted upon necropsy.

Rat Oral LD50 >5 mL/kg bw.

Under the test conditions, the oral LD50 of the test substance is >5 mL/kg bw in rats. Therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the Globally Harmonised System of classification and labelling of chemicals (GHS). No signal word or hazard statement is required.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

5 000 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

In an acute oral toxicity study performed similar to the OECD Guideline 401, a single dose of 5 mL/kg bw of undiluted test substance was given by oral gavage to a group of 5 male and 5 female Sprague Dawley rats. Animals were then observed for mortality, clinical signs and body weight changes for 14 days, and were all sacrificed for macroscopic examinations.

Only 1 male died within a 48-hour period. Toxic symptoms consisted of slight salivation, slight ataxia, slight respiratory depression and a slight decrease in spontaneous activity started 1 hour after dosing and persisted through 4 hours. By 24 hours, all animals appeared normal except one male which was unconscious and died. Mean body weight gains in females and males were 44 and 88 g, respectively. No gross pathological changes were noted upon necropsy.

Rat Oral LD50 >5 mL/kg bw.

Justification for classification or non-classification

Self classification:

Acute toxicity via Oral route:

Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 5 mL/kg bw