Registration Dossier
Registration Dossier
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EC number: 939-581-9 | CAS number: 1471314-81-4
Endpoint summary
Administrative data
Description of key information
A key skin sensitisation study was performed with Dunkin Hartley guinea pigs using the GPMT method of Magnusson and Kligman (according to OECD guideline 406; Sanders, 2000e). The test substance produced a 0% sensitisation rate to guinea pig skin.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- other:
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-10-25 - 1999-12-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Justification for non-LLNA: This study was conducted prior to the decision adopted in 2002 with regard to animal welfare.
- Specific details on test material used for the study:
- -Purity: approximately 79%
- Lot/batch No.: 876 TK
- Physical state: off white paste
- Storage condition of test material: room temperature, in the dark - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: 326-392 g
- Housing: singly or in pairs in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 ºC
- Humidity (%): 30-70 %
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light and twelve hours darkness - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 0.1 % w/v in distilled water
Topical induction: 75 % in distilled water
Topical Challenge: 5 % and 2 % w/v in distilled water - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 0.1 % w/v in distilled water
Topical induction: 75 % in distilled water
Topical Challenge: 5 % and 2 % w/v in distilled water - No. of animals per dose:
- 20 animals/dose and 10 animals as control group.
- Details on study design:
- RANGE FINDING TESTS:
- Selection of Concentration for Intradermal Induction: Four concentrations of test material were investigated (0.1 %, 0.5%, 1 % and 5% w/w in distilled water). A total of four guinea pigs were used, each guinea pig receiving four 0.1 ml injections of only one concentration of test material. The degree of erythema at the injection sites was assessed approximately 24, 48 and 72 hours and 7 days after injection. The selected concentration for the main study was 0.1% w/w in distilled water.
- Selection of Concentration for Topical Induction: Two guinea pigs (intradermally injected with Freund's Complete Adjuvant fifteen days earlier) were treated with the undiluted test material and three preparations of the test material (75%, 50% and 25% w/w in distilled water). The highest concentration (75 w/w in distilled water) producing only mild to moderate dermal irritation was selected for the topical induction stage of the main study.
-Selection of Concentration for Topical Challenge: The undiluted test material and two preparations of the test material (75%, 50% and 25% w/w in distilled water) were applied to the clipped flanks of two guinea pigs under occlusive dressings for an exposure period of 24 hours. Two further guinea pigs were treated with four lower concentrations of the test material (25%, 10%, 5% and 2% w/w in distilled water). The highest non-irritant concentration of the test material and one lower concentration were selected for the topical challenge stage of the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two exposures: intradermal injection and topical application
- Exposure period: 21 days
- Test groups: 20
- Control group: 10
- Site: approximately 40mm x 60 mm on the shoulder region
- Frequency of applications: three injections was applied (day 0) and one week later (day 7), a topical application of the test substance by an occlusive dressing of 48 hours was made.
- Duration: 21 days
- Concentrations: a) FCA plus distilled water in the ratio 1:1; b) distilled water and c) 50% v/v formulation of distilled water in 1:1 FCA/distilled water.
B. CHALLENGE EXPOSURE
- No. of exposures: one exposure per each concentration and each animal.
- Day(s) of challenge: 3 days
- Exposure period: 24 hours
- Test groups: two test groups.
- Control group: one control group of 10 animals
- Site: 20 mm x 20 mm
- Concentrations: 5% and 2 % (w/v, test substance in distilled water)
- Evaluation (hr after challenge): 72 hours from the start of the challenge application. - Challenge controls:
- The vehicle (distilled water) alone was applied
- Positive control substance(s):
- yes
- Remarks:
- (2-mercaptobenzothiazole)
- Positive control results:
- The positive control material induced a sensitisation response in the different groups with an incidence of sensitisation between 70 and 100%.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No erythema, no oedema or other reactions were noted
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No erythema, no oedema or other reactions were noted
- Interpretation of results:
- not sensitising
- Conclusions:
- The test substance produced a 0% (0/19) sensitisation rate to guinea pig skin. Therefore, it is not classified according to CLP Regulation.
- Executive summary:
The skin sensitisation study for the test substance was performed with Dunkin Hartley guinea pigs using the method GPMT (Guinea Pigs Maximisation test) of Magnusson and Kligman. Based on the results of range finding test, the concentrations chosen for the different phases of the study were: 0.1 % w/w in distilled water for the intradermal induction, 75 % w/w in distilled water for the Topical Induction step, and 5% and 2% w/w in distilled water for the Topical Challenge phase. The main test was carried out with thirty guinea pigs, twenty for the test and ten as control group. Individual reactions observed after intradermal induction and after topical induction were recorded, as well as the bodyweight of each animal at the start and at the end of the study. After intradermal induction, a discrete to moderate and confluent erythema was noted in all test group animals at the 24-hours observation and in twelve group animals at 48-hour observation. A discrete to moderate and confluent erythema with and without very slight oedema was noted at the topic induction sites of all test group animals at the 1-hour observation and fourteen test group animals at the 24-hour observation. No signs of erythema or oedema were noted in the control group. No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48-hour observation from the start of the challenge application.
The test substance produced a 0% (0/19) sensitisation rate to guinea pig skin.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The test substance produced a 0% sensitisation rate to guinea pig skin, based on the key study performed according to OECD guideline 406 and EU guideline B.6.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available results, the substance is not classified for skin sensitisation according to CLP Regulation.
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