Absolute of Dipteryx odorata (Fabaceae) obtained from beans by organic solvents treatment and subsequent ethanol extraction

Endpoint summary

Description of key information

- Oral LD50: 1380 mg/kg bw (K, Rel.2)

- Dermal LD50: 1260 mg/kg bw (WoE, 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:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Reason / purpose for cross-reference:

reference to other study

Principles of method if other than guideline:

- Standard acute method (limit test)

GLP compliance:

no

Remarks:

(pre-GLP)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data

Doses:

840, 1310, 2050, 3200 and 5000 mg/kg bw

No. of animals per sex per dose:

10 animals/dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Clinical observations, observations for mortality and toxic effects were made daily for 14 days
- Necropsy of survivors performed: No data

Statistics:

None

Preliminary study:

Not applicable

Sex:

not specified

Dose descriptor:

LD50

Effect level:

ca. 1 380 mg/kg bw

Based on:

test mat.

95% CL:

> 1 040 - < 1 720

Mortality:

- At 840 mg/kg bw: 1/10
- At 1310 mg/kg bw: 7/10
- At 2050 mg/kg bw: 9/10
- At 3200 mg/kg bw: 8/10
- At 5000 mg/kg bw: 10/10

Clinical signs:

other: - At 840 mg/kg bw: piloerection - At 1310 and 2050 mg/kg bw: lethargy and piloerection - At 3200 and 5000 mg/kg bw: lethargy, ataxia and loss of righting reflex.

Gross pathology:

No data

Other findings:

None

None

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the test conditions, the oral LD50 for test substance is 1380 mg/kg bw in rats. Therefore the test substance is classified as harmful if swallowed according to the criteria of the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

Executive summary:

In an acute oral toxicity study, Tonka Absolute was administered by oral route at a dose level of 840, 1310, 2050, 3200 and 5000 mg/kg bw in rats (ten/dose). Animals were observed for mortality and clinical signs for 14 days.

Mortality was observed at all tested doses. Piloerection, Lethargy, ataxia and loss of righting reflex were observed. In this study, the oral LD50 of Tabac absolute was 13800 mg/kg bw in rats.

Under the test conditions, the oral LD50 for test substance is 1380 mg/kg bw in rats. Therefore the test substance is classified as harmful if swallowed according to the criteria of the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and according to the GHS.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 380 mg/kg bw

Quality of whole database:

Only basic data given in the available studies. However, it was considered sufficiently robust to cover this endpoint.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Principles of method if other than guideline:

- Standard acute method (limit test)

GLP compliance:

no

Remarks:

(pre GLP)

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data.

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

No data.

Duration of exposure:

24 h

Doses:

320, 1250, 2500 and 5000 mg/kg bw

No. of animals per sex per dose:

2 animals at 320 mg/kg bw
4 animals at 1250 mg/kg bw
4 animals at 2500 mg/kg bw
2 animals at 5000 mg/kg bw

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Clinical observations, observations for mortality and toxic effects were made daily for 14 days
- Necropsy of survivors performed: No data

Statistics:

None

Preliminary study:

Not applicable

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

ca. 1 260 mg/kg bw

Based on:

test mat.

Mortality:

- At 320 mg/kg bw: 0/2
- At 1250 mg/kg bw: 3/4
- At 2500 mg/kg bw: 2/4
- At 5000 mg/kg bw: 2/2

Clinical signs:

other: - Clinical signs: none at 320 mg/kg bw. Anorexia and diarrhea observed at all higher doses. - Dermal reactions: moderate redness in 2, slight redness in 3.

Gross pathology:

No data available.

Other findings:

No data.

None

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the test conditions, the dermal LD50 for test substance is 1260 mg/kg bw in rabbits. Therefore the test substance is classified as harmful in contact with skin according to the criteria of the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

Executive summary:

In an acute dermal toxicity study, Tonka Absolute was given by dermal application at a dose level of 320, 1250, 2500 and 5000 mg/kg bw in rabbits. Animals were observed for mortality and clinical signs for 14 days.

Mortality occurred during the study (3/4 at 1250 mg/kg bw, 2/4 at 2500 mg/kg bw and 2/4 at 5000 mg/kg bw). Anorexia and diarrhea were observed at all higher doses, slight redness in three rabbits and moderate in two others. In this study, the dermal LD50 of Tonka Absolute was 1260 mg/kg bw in rabbits.

Under the test conditions, the dermal LD50 for test substance is 1260 mg/kg bw in rabbits. Therefore the test substance is classified as harmful in contact with skin according to the criteria of the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 260 mg/kg bw

Quality of whole database:

Only basic data given in the available studies. However, it was considered sufficiently robust to cover this endpoint.

Additional information

Acute toxicity by orale route:

One study was available and considered as the key study (Moreno, 1973). In this study, Tonka Absolute was administered by oral route at 840, 1310, 2050, 3200 and 5000 mg/kg bw in rats (ten/dose). Animals were observed for mortality and clinical signs for 14 days.

Mortality was observed at all tested doses. Piloerection, Lethargy, ataxia and loss of righting reflexwere observed. In this study, the oral LD50 of Tabac absolute was 1380 mg/kg bw in rats.

The oral LD50 for test substance is 1380 mg/kg bw in rats.

Acute toxicity by dermal route:

One study was available and considered as the key study (Moreno, 1973). In this study, Tonka Absolute was given by dermal application at a dose level of 320, 1250, 2500 and 5000 mg/kg bw in rabbits.Animals were observed for mortality and clinical signs for 14 days.

Mortality occurred during the study (3/4 at 1250 mg/kg bw, 2/4 at 2500 mg/kg bw and 2/4 at 5000 mg/kg bw). Anorexia and diarrhea were observed at all higher doses, slight redness in three rabbits and moderate in two others.In this study, the dermal LD50 of Tonka Absolute was 1260 mg/kg bw in rabbits.

The dermal LD50 for test substance is 1260 mg/kg bw in rabbits.

Justification for classification or non-classification

Harmonized classification:

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

Self classification:

Acute toxicity (Oral):

Based on the available information, the substance is:

- classified into category 4 (H302), according to the CLP and to the GHS.

Acute toxicity (Dermal):

Based on the available information, the substance is:

- classified into category 4 (H312) according to the CLP and to the GHS.

Acute toxicity (Inhalation):

No information was available. Not required for substances at the REACH Annex VII tonnage level.

Specific target organ toxicity: single exposure (Oral):

The classification criteria according to the Annex I 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.

The criteria for Transient Organ effects (STOT-SE Category 3) according to the CLP and to the GHS are not metsince narcotic effects were not observed in the acute oral toxicity study.

Specific target organ toxicity: single exposure (Dermal):

The classification criteria according to the CLP and to the GHS as specific target organ toxicant (STOT)– single exposure, dermal 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 (dermal) for a Category 1 classification (C≤ 1000 mg/kg bw) and at the guidance value (dermal) for a Category 2 classification (2000 mg/kg bw ≥ C > 1000 mg/kg bw). No classification is required.

The criteria for Transient Organ effects (STOT-SE Category 3) according to Annex I of the Regulation (EC) No. 1272/2008 are not met since narcotic effects were not observed in the acute dermal toxicity study.

Specific target organ toxicity: single exposure (Inhalation):

No information was available. Not required for substances at the REACH Annex VII tonnage level.

Aspiration hazard:

The substance is not a hydrocarbon and no effects were observed on lungs in oral studies, therefore the criteria for aspiration toxicity according to the CLP and to the GHS are not met.