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EC number: 274-765-6 | CAS number: 70693-39-9
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- (use of an irritating dose for challenge exposure; lack of data on test substance)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
Test material
- Reference substance name:
- 189200-42-8
- Cas Number:
- 189200-42-8
- IUPAC Name:
- 189200-42-8
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hartley Albino
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Raleigh, NC, USA
- Age at study initiation: ca. 5 weeks
- Weight at study initiation: 286 - 342 g
- Housing: animals were housed separately in suspended stainless steel and wire mesh cages with absorbent paper below the cages.
- Diet: Agway PROLAB Certified Guinea Pig Chow, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 9 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 40 - 70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 14 Sep 1995
To: 16 Oct 1995
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: peanut oil, FCA
- Concentration / amount:
- intradermal: 5%
epicutaneous: 100%
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: peanut oil, FCA
- Concentration / amount:
- 50%
- No. of animals per dose:
- 10 irritation control animals, 10 positive control animals, 20 animals in test groups
- Details on study design:
- RANGE FINDING TESTS:
A primary irritation test (PIT) was performed to determine suitable concentrations for intradermal and epicutaneous induction. Therefore, three concentrations of the test substance (0.1, 1.0 and 5.0% v/v in peanut oil) were administered intradermally to 2 animals per concentration. The injection sites were evaluated 24 and 48 h after injection. None of the injection sites for the 5.0% animals showed skin corrosion or irritation at either the 24 or 48 h observations. Therefore, 5% of the test substance was chosen for intradermal induction. The PIT also indicated that 100% of the test substance applied topically produced mild to moderate irritation whereas 50% of the test substance was non-irritating. Therefore, concentrations of 100% of the test substance were chosen for the topical induction dose and 50% for the challenge dose, respectively.
MAIN STUDY
A. INDUCTION EXPOSURE
On Day 0, 3 pairs of intradermal injections (0.1 mL) were made in the shoulder region of the test animals. On Day 7, 100% of the test substance (0.5 mL) was applied topically under occlusive conditions for 48 h on the shoulder region of the test animals.
- Exposure period: 3 single injections (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: 5% (v/v) test substance in peanut oil
Injection 3: 5% (v/v) test substance in a 1:1 mixture (v/v) FCA/water
Epicutaneous: test substance (0.5 mL, occlusive conditions)
Evaluation: 1 and 24 h after each induction
- Control group:
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: peanut oil
Injection 3: peanut oil in a 1:1 mixture (v/v) FCA/water
Epicutaneous: peanut oil (0.5 mL, occlusive conditions)
Evaluation: 1 and 24 h after each induction
B. CHALLENGE EXPOSURE
On Day 21, the test substance in peanut oil (50% (v/v, 0.4 mL) was applied topically under occlusive conditions for 24 h to all animals.
- No. of exposures: 1
- Exposure period: 24 h
- Test groups: test substance in peanut oil (left flank) and peanut oil only (right flank)
- Control group: test substance in peanut oil (left flank) and peanut oil only (right flank)
- Evaluation (hr after challenge): 24 and 48 h
Due to the fact that the challenge dosing with 50% test substance was more irritating than is ideal for the challenge and rechallenge phases, the concentration for rechallenge dosing was lowered to 10% of the test substance.
C. RECHALLENGE EXPOSURE
On Day 28, the test substance in peanut oil (10% (v/v, 0.4 mL) was applied topically under occlusive conditions for 24 h to all animals.
- No. of exposures: 1
- Exposure period: 24 h
- Test groups: test substance in peanut oil (right flank) and peanut oil only (left flank)
- Control group: test substance in peanut oil (right flank) and peanut oil only (left flank)
- Evaluation (hr after rechallenge): 24 and 48 h after patch removal - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole (MBT): intradermal induction: 3%, epicutaneous induction: 25%, challenge: 0.5%; no rechallenge was done
Results and discussion
- Positive control results:
- The positive control substance (0.4% 2-Mercaptobenzothiazole in peanut oil) induced positive reactions in 10/10 animals (100%), thus meeting the reliability criteria.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: 0%; Challenge: 50%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction: 5% (intradermal) and 100% (epicutaneous); Challenge: 50%
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Induction: 3% (intradermal) and 25% (epicutaneous); Challenge: 0.5%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0%; Challenge: 50%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 5% (intradermal) and 100% (epicutaneous); Challenge: 50%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Induction: 3% (intradermal) and 25% (epicutaneous); Challenge: 0.5%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: 0%; Challenge: 50%; Rechallenge: 10%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction: 5% (intradermal) and 100% (epicutaneous); Challenge: 50%; Rechallenge: 10%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0%; Challenge: 50%; Rechallenge: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 5% (intradermal) and 100% (epicutaneous); Challenge: 50%; Rechallenge: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Dose level:
- 0.4%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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