Gum of Cistus ladaniferus (Cistaceae) obtained from stems and leaves by extraction with alkaline solution

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

Labdanum oil and Labdanum gum are obtained from the same botanical source, the Cistus ladaniferus (Cistaceae).

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not applicable

GLP compliance:

not specified

Test type:

fixed dose procedure

Specific details on test material used for the study:

clear, yellow liquid

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: from 2.5 to 3.0 Kg
- Housing: individually
- Diet : commercial diet
- Water ad libitum:

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 240 cm²
- % coverage: 10% of body surface

Duration of exposure:

24 hours

Doses:

5 ml/kg

No. of animals per sex per dose:

3 animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily (toxic effects, dermal reactions and mortality)
- Necropsy of survivors performed: yes

Key result

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Mortality:

No mortality was observed.

Clinical signs:

Erythema and edema were observed

Body weight:

No data

Gross pathology:

No data

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS. Therefore, the registered substance is not considered toxic by dermal route.

Executive summary:

In an acute dermal toxicity study (limit test), three rabbits were given a single dermal application of labdanuml at 5000 mL/kg bw. Animals were observed for mortality and clinical signs for 14 days.

No mortality was observed. Edema and Erythema were observed.

In this study, the dermal LD50 of the test item was higher than 5000 mL/kg bw in rats.

Under the experimental conditions of this study, the test item is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS. Therefore, the registered substance is not considered toxic by dermal route.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not applicable

GLP compliance:

not specified

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

Labdanum

EC Number:

283-893-1

EC Name:

Labdanum

Cas Number:

84775-64-4

IUPAC Name:

labdanum

Test material form:

liquid

Details on test material:

Clear yellow liquid

Specific details on test material used for the study:

clear, yellow liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: from 2.5 to 3.0 Kg
- Housing: individually
- Diet : commercial diet
- Water ad libitum:

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 240 cm²
- % coverage: 10% of body surface

Duration of exposure:

24 hours

Doses:

5 ml/kg

No. of animals per sex per dose:

3 animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily (toxic effects, dermal reactions and mortality)
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Mortality:

No mortality was observed.

Clinical signs:

Erythema and edema were observed

Body weight:

No data

Gross pathology:

No data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.

Executive summary:

In an acute dermal toxicity study (limit test), three rabbits were given a single dermal application of labdanum at 5000 mL/kg bw. Animals were observed for mortality and clinical signs for 14 days.

No mortality was observed. Edema and Erythema were observed.

In this study, the dermal LD50 of the test item was higher than 5000 mL/kg bw in rats.

Under the experimental conditions of this study, the test item is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.