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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1975
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Principles of method if other than guideline:
Method according to the typical testing for acute dermal toxicity in a limit test: topical application of substance on rabbits at one high dose.
GLP compliance:
no
Remarks:
(pre-GLP)

Test material

Constituent 1
Reference substance name:
Cypress, Cupressus sempervirens, ext.
EC Number:
283-626-9
EC Name:
Cypress, Cupressus sempervirens, ext.
Cas Number:
84696-07-1
IUPAC Name:
Cypress, Cupressus sempervirens, ext.
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Cypress oil

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No data

Test system

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): 5000 mg/kg bw

Duration of treatment / exposure:
Single treatment (24 h exposure)
Observation period:
14 days
Number of animals:
Total: 10 animals
Details on study design:
No data

Results and discussion

In vivo

Irritant / corrosive response data:
- Mortality was observed in 2/10 animals (first animal died on Day 4 and second animal died on Day 13).
- Slight and moderate redness were observed in 2/10 and 7/10 animals, respectively.
- Moderate oedema was observed in 9/10 animals.
Other effects:
- No other clinical signs were observed

Any other information on results incl. tables

Acute dermal LD50 of test material was higher than 5000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Under the test conditions, Cypress oil induced slight to moderate skin irritation in rabbits.
Executive summary:

In an acute dermal toxicity study (limit test), ten rabbits were given a single dermal application of Cypress oil at 5000 mg/kg bw. Animals were observed for mortality, clinical signs and local reactions for 14 days.

Mortality was observed in 2/10 animals. Slight and moderate redness were observed in 2/10 and 7/10 animals respectively. Moderate oedema was observed in 9/10 animals. No other clinical signs were observed.

Under the test conditions, Cypress oil 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.

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