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EC number: 619-269-6 | CAS number: 97398-80-6
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Endpoint summary
Administrative data
Description of key information
In a study according OECD TG 406 performed on guinea-pigs the substance is not to be classified as skin sensitizer (reference 7.4.1 -1).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan 29 - Sep 24, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- With the existing data from this study not only being acceptable but of good quality (Klimisch Score 1), this study precludes the need for an additional LLNA study. In addition, a supplementary LLNA study would violate the ECHA objectives with regards to animal welfare.
- Species:
- guinea pig
- Strain:
- other: HsdPoc:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen
- Age at study initiation: about 6 weeks
- Weight at study initiation: The mean initial body weight at the start of the study was 363 g (range from 337 to 391 g).
- Housing: Five guinea pigs were housed in type GM/5 (EBECO) Makrolon cages with a shelter and placed on mobile racks.
- Diet: ad libitum, Provimi Kliba 3418.0
- Water: ad libitum, tap water
- Acclimation period: 7 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 23
- Humidity (%): 55 to 60
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 50g/L/0.1 mL
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 50 g/L
- Day(s)/duration:
- Day 8/48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 10 g/L
- Day(s)/duration:
- Day 22/24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Pretest: 5 females
Group 1: negative control group (5 females)
Group 2: test material group (10 females) - Details on study design:
- RANGE FINDING TESTS:
- no pretreatment, intradermal injection: 0, 1, 5, 10, 25, 50 g/L given to one animal in paraffin oil
- topical applications (48 h), no pretreatment: 1, 10, 50, 100, and 200 g/L in polyethylene glycol 400
- topical applications (24 h), FCA pretreatment: 1, 5, 10, and 50 g/L in polyethylene glycol 400
MAIN STUDY
A1. INDUCTION EXPOSURE (intradermal injection)
- No. of exposures: 6 injections of 0.1 mL each, three on each side of the spinal column
- Test groups: 0.1 mL FCA + NaCl, 0.1 mL 50g/L test item ad liquid paraffin, 0.1 mL FCA + 50 g/L test item in NaCl solution
- Control group: 0.1 mL FCA + NaCl, 0.1 mL liquid paraffin, 0.1 mL FCA + NaCl- Site: cranial, medial, caudal
- Frequency of applications: single
A2. INDUCTION EXPOSURE (topical application)
- No. of exposures: one week after injection (A1) single topical application of a filter plate soaked with either test solution, or vehicle
- Test groups: 50 g/L test material ad PEG 400
- Control group: PEG 400
- Site: cranial, medial, caudal- Frequency of applications: single
- Duration: 48 h, occlusive
B. CHALLENGE EXPOSURE
- No. of exposures: single two weeks after topical induction (A2)
- Day(s) of challenge: 1d
- Exposure period: 2 weeks after topical application
- Test groups: 10 g/L test item ad PEG 400- Control group: PEG 400
- Site: cranial, medial, caudal
- Evaluation (hr after challenge): 48 and 72 h
- Observations
During the induction phase, the guinea pigs were examined on days 2, 3, 7, 11, 12, 15, and 22 of the experimental part for local skin reactions and the results were documented.The behavior and general condition of all animals were monitored daily. The challenge sites were investigated for reactions 48 hours after start of the challenge. Further inspections followed 72 hours after start of the challenge, to detect weak or slowly developing reactions. After the challenge, skin changes at the application sites were evaluated according to the following MAGNUSSON and KLIGMAN scheme. - Positive control substance(s):
- yes
- Remarks:
- Hexylcinnamaldehyde
- Positive control results:
- 50% positive reactions with control substance
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs of toxicity
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs of toxicity
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 10 g/L
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the given experimental conditions, the test material induced no skin sensitization.
- Executive summary:
The test material was investigated for skin sensitizing properties in the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969). 5 females were treated with the vehicles liquid paraffin and polyethylene glycol 400 (group 1) and 10 females were treated with the test material (group 2). Induction included intradermal injection of the test material preparation in liquid paraffin (50 g/L with and without Freund's complete adjuvant) on experimental day 1, and topical application of test material preparation in polyethylene glycol 400 (50 g/L) for 48 hours on experimental day 8.
Challenge by topical application of the test material preparation in polyethylene glycol 400 (10 g/L) for 24 hours was performed two weeks after topical induction and readings were taken at 48 hours and 72 hours after start of treatment.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. After challange no positive reactions were seen 48 or 72 hours after treatment with the test material.
Under the given experimental conditions, the test material induced no skin sensitising reactions.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The test material was investigated according to OECD TG 406 for skin sensitizing properties in the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969). 5 females were treated with the vehicles liquid paraffin and polyethylene glycol 400 (group 1) and 10 females were treated with the test material (group 2). Induction included intradermal injection of the test material preparation in liquid paraffin (50 g/L with and without Freund's complete adjuvant) on experimental day 1, and topical application of test material preparation in polyethylene glycol 400 (50 g/L) for 48 hours on experimental day 8.
Challenge by topical application of the test material preparation in polyethylene glycol 400 (10 g/L) for 24 hours was performed two weeks after topical induction and readings were taken at 48 hours and 72 hours after start of treatment.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. After challange no positive reactions were seen 48 or 72 hours after treatment with the test material.
Under the given experimental conditions, the test material induced no skin sensitizing reactions.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this information, the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.
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