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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Justification for type of information:
D-Limonene is one of the main constituents of multiconstituent substance REACTION MASS OF BETA-PHELLANDRENE AND D-LIMONENE AND L-LIMONENE. Therefore, data on d-limonene can be used for extrapolation to REACTION MASS OF BETA-PHELLANDRENE AND D-LIMONENE AND L-LIMONENE. See read-across justification document in section 13.
Cross-reference
Reason / purpose:
read-across source

Data source

Materials and methods

Test material

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

Results and discussion

Preliminary study:
Not applicable
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 evidence of toxicity; all animals appeared normal at the end of the study
Body weight:
Normal gain in bodyweight
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
Dermal reactions:
- Slight erythema in 6, 6, 3 and 1 animals on Days 1, 2, 3 and 4, respectively; moderate erythema in 3 animals on Day 1
- Slight edema in 5, 5, 4 and 1 animals on Days 1, 2, 3, and 4, respectively; moderate edema in 4 and 1 animals on Days 1 and 2
- Complete recovery within 5 days
- No signs of atonia were observed during the study

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 of d-limonene is greater than 2000 mg/kg bw in rabbits therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272/2008.
Executive summary:

In an acute dermal toxicity study (limit test), a group of 10 New Zealand White rabbits were administered a single dermal dose of d-limonene at 5000 mg/kg bw on clipped abraded abdominal skin using an occlusive patch for 24 hours. Animals were then observed for mortality, clinical signs, bodyweights and dermal reactions for 7 days and were all macroscopically necropsied after sacrifice.

 

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

 

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