Reaction mass of 3-isopropyl-6-methylenecyclohexene and (4R)-1-methyl-4-(prop-1-en-2-yl)cyclohexene and (4S)-1-methyl-4-(prop-1-en-2-yl)cyclohexene

Acute Toxicity: dermal

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

Materials and methods

Test material

Test material information

Constituent 1

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

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

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.