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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 September 2015 to 23 September 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Sage, Salvia sclarea, ext.
EC Number:
283-911-8
EC Name:
Sage, Salvia sclarea, ext.
Cas Number:
84775-83-7
Molecular formula:
not relevant for a UVCB substance
IUPAC Name:
Essential oil of Salvia sclarea (Labiatae) obtained from leaves, flowers and twigs by steam distillation
Details on test material:
- Physical state: brown waxy solid
- Analytical purity:100%

- Expiration date of the lot/batch: 13 July 2017
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
PROCEDURE
- On the day before treatment, the back and flanks of each animal were clipped free of hair.
- Using available information on the toxicity of the test item, five male and five female rats were treated with the test item at a dose level of 2000 mg/kg
- The calculated volume of test item, as received, waas applied as evenly as possible to an area of shorn skin (approximately 10 % of the total body surface area) using a graduated syringe.
- A piece of surgical guaze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.
- The animals were caged individually throughout the study.
- Shortly after dosing the dressings were examined to ensure they were securely in place.
- After the 24 hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil BP to remove any residual test item.
- The animals were caged individually for the 24 hour exposure period.
- After the 24 hour contact period, the bandages were carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil BP to remove any residual test item.
- The animals were returned to group housing for the remainder of the test period.
Duration of exposure:
24 hours
Doses:
2000mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
TEST ITEM FORMULATION AND EXPERIMENTAL PREPARATION
- The test item was weiged out weighed out according to each animals's individual body weight prior to application
- Absorption of the test item was not determined.
Statistics:
- Data evaluations included the relationsip, if any, between exposure of the animal to the test item and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, body weight changes, mortality and other toxicological effects.
- Using the mortality data obtained, and estimate of the acture dermal median lethal dose (LD50) of the test item was made.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
- There were no deaths
Clinical signs:
- No signs of systemic toxicity were noted during the observation period (see Table 1, attached).
Body weight:
- Individual body weights and body weight changes are shown in Table 4 (attached).
- Animals showed expected gains in body weight with the exception of two females, one showed no gain in body weight during the first & second week. The second female showed no gain in body weight during the first week and e expected gain in body weight took place during the second week.
Gross pathology:
- Individual necropsy findings are given in Table 5 (attached).
- No abnormalities were noted at necropsy.
Other findings:
DERMAL REACTIONS
- Individual dermal reactions are shown in Tables 2 and 3 (attached).
- No signs of dermal irritation were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.
Executive summary:

GUIDELINE

Acute dermal toxicity was investigated in the Wistar rat using a method designed to be compatible with OECD Guidelines for the Testing of Chemicals No 402 "Acute Dermal Toxicity" (adopted 24 February 1987) and Method B.3 Acute Toxicity (Dermal) of Commission Regulation (EC) No 440/2008.

METHOD

Ten animals (five males and five females) were given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000 mg/kg bw. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

RESULTS

Mortality: No animal deaths took place during the study.

Clinical observations: No signs of systemic toxicity were observed.

Dermal irritation: No signs of dermal irritation were observed.

Body weight: . Animals showed expected gains in body weight with the exception of two females, one showed no gain in body weight during the first & second week. The second female showed no gain in body weight during the first week and expected gain in body weight took place during the second week

Necropsy: No abnormalities were noted at necropsy.

CONCLUSION

The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.