Registration Dossier
Registration Dossier
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EC number: 214-478-5 | CAS number: 1132-61-2
Endpoint summary
Administrative data
Description of key information
In a GLP-study according to OECD TG 406 (Guinea Pig Maximisation Test), the substance did not induce any adverse effects and is therefore considered to be not skin sensitising (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:
- 2003-09-15 to 2003-10-23
- 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 (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted when the guinea pig test methods (acc. to OECD TG 406) were still standard tests.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Centre de Production animale (45160 Olivet, France)
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: not available
- Weight at study initiation: 238 - 366 g
- Housing: no information available
- Diet: ad libitum, Guinea Pig breeding Diets (Cobayes-Elevage)
- Water: no information available
- Acclimation period: 5 days
- Indication of any skin lesions: no information available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 39 -79
- Air changes (per hr): no information available
- Photoperiod (hrs dark / hrs light): no information available - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 25 %
- Day(s)/duration:
- 7
- Adequacy of induction:
- other: no necrosis induced
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 %
- Day(s)/duration:
- 2
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 50 % and 100 %
- Day(s)/duration:
- 2
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
1. The maximum non-necrotising concentration was determined by injecting intradermally 1.562 %, 3.125 %, 6.25 %, 12.5 %, 25 % and 50 % of test substance (diluted in physiological saline) into two female guinea pigs. No necrosis was observed up to 25 %.
2. The pre-maximum non-irritant concentration was determined by appliying topically (occlusive) 12.5 %, 25 % and 50 % and 100 % of test substance (diluted in physiological saline) to two female guinea pigs for 24 hours. No cutaneous reaction were observed up to 100 %.
3. The maximum non-irritant concentration was determined by appliying topically (occlusive) 12.5 %, 25 % and 50 % and 100 % of test substance (diluted in distilled water) to three female guinea pigs for 24 hours, after an intradermal injection with hysiological saline, a topical application with distilled water and a 17-day rest phase. No cutaneous reaction were observed up to 100 %.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 9 days
- Test groups: 1
- Control group: 1
- Site: intradermal (twice) and topical (same skin area)
- Frequency of applications: 2 intradermal (7 days) and 1 topical (2 days)
- Duration: 18 days
- Concentrations: 25 %, Freud's Complete Adjuvant at 50 % (diluted in physiological saline) and Freud's Complete Adjuvant at 50 % and 50 % test item (both diluted in physiological saline) intradermally, and 100 % topically (24 h after brushing with 0.5 mL of a 10 % SLS solution)
Between induction and challgenge phase, the guinea pigs rested for 18 days.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Days of challenge: 2
- Exposure period: 48 h
- Test groups: 1
- Control group: 1
- Site: topical
- Concentrations: 50 % and 100 %
- Evaluation (hr after challenge): 24 and 48
- Positive control substance(s):
- yes
- Positive control results:
- Data of earlier test with benzocaine and neomycin sulfate are provided, showing clear cutaneous reactions (at 48 h) of the guinea pigs.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 12.5 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 12.5 %
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is considered to be not skin sensitising.
- Executive summary:
The skin sensitisation effects of the substance were investigated in a guinea pig maximisation tests according to OECD TG 406 under GLP-conditions. In three preliminary studies the concentrations to be applied during the various experimental phases were determined using two or three female guinea pigs. After a 9 day induction phase, consisting of 7 days intradermal exposure (twice) with the test substance (diluted to 25 % in physiological saline) and a 2 day two topical application with 100 % (after brushing with 10 % SLS), the guinea pigs (all females) rested for 18 days.
Then the guinea pigs were challenged for two days by applying the substance topically (occlusive) in concentrations of 50 % and 100 %. At both reading times (24 h and 48 h) no cutaneous reactions were observed. Therefore, the substance is considered to be not skin sensitising.
- 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 skin sensitisation effects of the substance were investigated in a guinea pig maximisation tests according to OECD TG 406 under GLP-conditions. In three preliminary studies the concentrations to be applied during the various experimental phases were determined using two or three female guinea pigs. After a 9 day induction phase, consisting of 7 days intradermal exposure (twice) with the test substance (diluted to 25 % in physiological saline) and a 2 day two topical application with 100 % (after brushing with 10 % SLS), the guinea pigs (all females) rested for 18 days.
Then the guinea pigs were challenged for two days by applying the substance topically (occlusive) in concentrations of 50 % and 100 %. At both reading times (24 h and 48 h) no cutaneous reactions were observed. Therefore, the substance is considered to be not skin sensitising.
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 data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is not considered to be classified for skin sensitization under Regulation (EC) No 1272/2008, as amended for the fifteenth time in Regulation (EU) 2020/1182.
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