Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1972
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Test method and results not sufficiently detailed
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method according to the typical testing for acute dermal toxicity: topical application of substance on 10 rabbits at selected doses.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.9-2.3 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: Abdominal skin
- Type of wrap if used: Wrapped with binder of rubber dam, gauze and adhesive tape

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: Observed for erythema, edema and atonia
Statistics:
None

Results and discussion

Preliminary study:
None
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
no data
Body weight:
Normal gain in body weight
Gross pathology:
No abnormalities found at necropsy
Other findings:
- Slight erythema in 3 animals on Day 1; 4 animals on Day 2, 3 and 4; 2 animals on Day 5, recovered on Day 6
- Moderate erythema in 5 animals on Day 1; 2 animals on day 2 and 3, recovered on Day 4
- Slight edema in 7 animals on Day 1; 5 animals on Day 2; 4 animals on Day 3 and one animal on Day 4, recovered on Day 5
- Moderate edema was seen only in one animal on Day 1

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of delta-3-carene is greater than 2000 mg/kg bw in rabbits and therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272/2008.
Executive summary:

delta-3-Carene was tested for acute dermal toxicity in New Zealand White rabbit in a limit dose assay. 10 rabbits were administered a single dermal dose of delta-3-carene at 5000 mg/kg bw on clipped skin using an occlusive patch for 24 hours. All animals were observed for mortality, body weights and dermal reactions for 7 days. Animals were killed at the end of the study and subjected to necropsy for macroscopical examination.

No deaths occurred throughout the study. At necropsy, macroscopic examination of main organs showed no abnormalities. Adverse dermal reactions noted were slight to moderate erythema and edema. Normal body weight gain was observed in all animals. The acute dermal LD50 was greater than 5000 mg/kg bw.

 

The acute dermal LD50 of delta-3-carene is greater than 2000 mg/kg bw in rabbits and therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272/2008.