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

Acute Toxicity: dermal

Administrative data

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.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1973

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for 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:

Method according to the typical testing for acute dermal toxicity test: topical application of substance on rabbits at several doses.

GLP compliance:

no

Remarks:

(pre-GLP)

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

No data

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 320, 1250, 2500 and 5000 mg/kg bw

Duration of treatment / exposure:

Single treatment (24 h exposure)

Observation period:

14 days

Number of animals:

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

Details on study design:

No data

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Remarks on result:

probability of moderate irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Remarks on result:

probability of moderate irritation

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Remarks on result:

probability of weak irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Remarks on result:

probability of moderate irritation

Irritant / corrosive response data:

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
- Dermal reactions: moderate redness in 2, slight redness in 3.

Other effects:

Clinical signs: none at 320 mg/kg bw. Anorexia and diarrhea observed at all higher doses.

Acute dermal LD50 of test material is 1380 mg/kg bw

Interpretation of results:

study cannot be used for classification

Conclusions:

Under the test conditions, the test substance induced slight to moderate skin irritation in rabbits.

Executive summary:

In an acute dermal toxicity study, Tonka Absolute wasgiven 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 test substance induced slight to moderate skin irritation in rabbits.

This study was conducted according to a non-standard method and adequate scoring of skin effects was not provided, therefore it was not possible to take a decision on the classification based solely on this study.

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

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

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

951-766-6

Molecular formula:

Not relevant, UVCB substance

IUPAC Name:

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

Test material form:

other: Crystal

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data.

Administration / exposure

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

Results and discussion

Preliminary study:

Not applicable

Effect levels

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.

Any other information on results incl. tables

None

Applicant's summary and conclusion

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.