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EC number: 206-596-0 | CAS number: 355-93-1
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Endpoint summary
Administrative data
Description of key information
There was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the test substance.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 May 2007 to 11 January 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- The study was not commissioned with compliance with REACH as a goal, rather the study was commissioned during early product development.
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Lot No. 08230AB
- Purity: 99.8% - Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: The Jackson Laboratory, Bar Harbor, ME.
- Females nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known: Animals were examined to ensure good health and suitability as test subjects for use in the study.
- Age at study initiation: appromixately 7-8 weeks
- Weight at study initiation: 17-21g
- Housing: housed individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week
- Indication of any skin lesions: Animals were examined to ensure good health and suitability as test subjects for use in the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25°C
- Humidity (%): 37-61%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 / 12
- IN-LIFE DATES: From: 07 June 2007 To: 11 June 2007 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 11.3, 22.5, 33.8 and 45% in an acetone:olive oil (4:1) vehicle.
Highest concentration tested was 45% which was considered as the solubility limit in an acetone:olive oil 4:1 mixture. - No. of animals per dose:
- 5 females/dose
- Details on study design:
- Five mice per group were dosed with the test substance at concentrations of 11.3, 22.5, 33.8 and 45% in an acetone:olive oil (4:1) vehicle. The mice were dosed once daily at approximately the same time for three consecutive days. All mice were observed twice daily on dosing days immediately prior to and approximately 4-6 hours after dosing, then once daily for moribundity, mortality, and any signs of toxicity and skin reactions. Approximately 2 days after the last dose, mice were injected with the radio-label ([3H]-thymidine) and approximately 5 hours later, the auricular nodes were excised and single-cell suspensions were prepared. The cells were washed with phosphate-buffered saline to remove unbound radiolabel and then precipitated with 5% trichloroacetic acid. The total radiolabel incorporation in these precipitates was subsequently quantitated by liquid scintillation spectrometry. A single animal was dosed with less than the required volume of [3H]-thymidine (50% dose group) and this animal was not included in the analysis.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- other: 1-chloro-2,4-dinitrobenzene (DNCB)
- Statistics:
- The observed values of disintegrations per minutes (DPM) of acid-precipitated auricular lymph node cells were analysed using analysis of variance (ANOVA). Statistical analyses were performed using SigmaStat for windows software.
- Positive control results:
- 2.5 µg/mL of DNCB: Proliferative response - 13024.53 DPM/lymph node; Stimulation index – 19.39
42.5% of HCA: Proliferative response - 4260.59 DPM/lymph node; Stimulation index – 6.34 - Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- vehicle control
- Parameter:
- SI
- Value:
- 1.66
- Test group / Remarks:
- 11.3%
- Parameter:
- SI
- Value:
- 1.66
- Test group / Remarks:
- 22.5%
- Parameter:
- SI
- Value:
- 1.31
- Test group / Remarks:
- 33.8%
- Key result
- Parameter:
- SI
- Value:
- 1.46
- Test group / Remarks:
- 45%
- Cellular proliferation data / Observations:
- Evidence of induction of T-cell proliferation was not observed with the test substance, as the stimulation index was less than three at each of the test concentrations
There were no mortalities and no signs of systemic toxicity or irritation noted for the test and control animals. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- There was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the test substance.
- Executive summary:
Five mice per group were dosed with the test substance at concentrations of 11.3, 22.5, 33.8 and 45% in an acetone:olive oil (4:1) vehicle. The mice were dosed once daily at approximately the same time for three consecutive days. All mice were observed twice daily on dosing days immediately prior to and approximately 4-6 hours after dosing, then once daily for moribundity, mortality, and any signs of toxicity and skin reactions. Approximately 2 days after the last dose, mice were injected with the radio-label ([3H]-thymidine) and approximately 5 hours later, the auricular nodes were excised and single-cell suspensions were prepared. The cells were washed with phosphate-buffered saline to remove unbound radiolabel and then precipitated with 5% trichloroacetic acid. The total radiolabel incorporation in these precipitates was subsequently quantitated by liquid scintillation spectrometry.
There were no mortalities and no signs of systemic toxicity or irritation noted for the test and control animals. Evidence of induction of T-cell proliferation was not observed with the test substance, as the stimulation index was less than three at each of the test concentrations.
The positive control groups had significantly increased DPM values and a mean stimulation index >3.
There was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the test substance.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Five mice per group were dosed with the test substance at concentrations of 11.3, 22.5, 33.8 and 45% in an acetone:olive oil (4:1) vehicle. The mice were dosed once daily at approximately the same time for three consecutive days. All mice were observed twice daily on dosing days immediately prior to and approximately 4-6 hours after dosing, then once daily for moribundity, mortality, and any signs of toxicity and skin reactions. Approximately 2 days after the last dose, mice were injected with the radio-label ([3H]-thymidine) and approximately 5 hours later, the auricular nodes were excised and single-cell suspensions were prepared. The cells were washed with phosphate-buffered saline to remove unbound radiolabel and then precipitated with 5% trichloroacetic acid. The total radiolabel incorporation in these precipitates was subsequently quantitated by liquid scintillation spectrometry.
There were no mortalities and no signs of systemic toxicity or irritation noted for the test and control animals. Evidence of induction of T-cell proliferation was not observed with the test substance, as the stimulation index was less than three at each of the test concentrations.
The positive control groups had significantly increased DPM values and a mean stimulation index >3.
There was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the test substance.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
There was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the test substance. OFPMA does not fulfil the criteria for skin sensitisation classification according to European CLP Regulation (EC) No 1272/2008 (as amended).
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