(S)-p-mentha-1,8-diene

Endpoint summary

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).