Registration Dossier

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:
read-across source
Reason / purpose:
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).