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Toxicological information

Acute Toxicity: dermal

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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:
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:
read-across source
Qualifier:
equivalent or similar to
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 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:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not applicable
GLP compliance:
not specified
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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.