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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Skin sensitisation:

Key study: Read-across from the analogue susbtance d-limonene. Test method OECD 429. GLP study. The estimated EC3 value is 68.5 %, therefore, the substance is classified as skin sensitiser 1B according to CLP Regulation.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from an analogue substance for which there is a in vivo study available (Klimish =2).
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See cross reference to justification of read-across.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across: supporting information
Key result
Parameter:
EC3
Value:
68.5
Remarks on result:
other: Based on the read-across from the analogue substance d-limonene.
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
Based on the read-across from the analogue substance d-limonene, l-limonene is estimated to have an EC3 value of 68.5 %, therefore, the substance is classified as skin sensitiser 1B according to CLP Regulation (EC) Nº 1272/2008.
Executive summary:

Based on the read-across from the analogue substance d-limonene, l-limonene is estimated to have an EC3 value of 68.5 %, therefore, the substance is classified as skin sensitiser 1B according to CLP Regulation (EC) Nº 1272/2008.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

There was no data on l-limonene. A read-across approach with the structural analogue d-limonene was used to assess the sensitising potential of l-limonene. For further information on read-across justification, see section 13: point "read-across approach"

A study was identified as a key study (Warbrick, 2001). In this OECD guideline 429 GLP study, d-limonene at exposure concentration of 0 (vehicle), 25, 50 and 100% v/v resulted in stimulation index of 1, 1.84, 2.44 and 3.95, respectively. The calculated EC3-value for limonene was found to be 68.5% (17125 µg/cm²).

This value is close to reported LLNA weighed mean EC3 values from five LLNA studies (=10075 µg/cm²). Moreover, these animal data are consistent with the NOEL (highest concentration tested with no sensitisation in human) found in humans, based on Human Repeated Insult Patch Test (10000 µg/cm²) (see section 7.10.4).

 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results found with d-limonene, l-limonene was considered as skin sensitising and is classified as Skin Sens. 1B, H317 (May cause an allergic skin reaction) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP).