Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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 for cross-reference:
read-across source

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
p-mentha-1(7),2-diene
EC Number:
209-081-9
EC Name:
p-mentha-1(7),2-diene
Cas Number:
555-10-2
Molecular formula:
C10H16
IUPAC Name:
3-isopropyl-6-methylenecyclohexene
Constituent 2
Chemical structure
Reference substance name:
(R)-p-mentha-1,8-diene
EC Number:
227-813-5
EC Name:
(R)-p-mentha-1,8-diene
Cas Number:
5989-27-5
Molecular formula:
C10H16
IUPAC Name:
(4R)-isopropenyl-1-methylcyclohexene
Constituent 3
Chemical structure
Reference substance name:
(S)-p-mentha-1,8-diene
EC Number:
227-815-6
EC Name:
(S)-p-mentha-1,8-diene
Cas Number:
5989-54-8
Molecular formula:
C10H16
IUPAC Name:
(4S)-isopropenyl-1-methylcyclohexene
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:
other: No evidence of toxicity; all animals appeared normal at the end of the study
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.