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EC number: 202-414-9 | CAS number: 95-38-5
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
- Study period:
- 09 Feb 1981 to 02 Mar 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- difference in exposure details
- GLP compliance:
- no
- Type of study:
- Maurer optimisation test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Maurer optimisation test has been carried out as an animal test to predict human sensitization. This test is similar to the OECD recommended Guinea Pig Maximization Test (GPMT).
Test material
- Reference substance name:
- 2-(2-heptadec-8-enyl-2-imidazolin-1-yl)ethanol
- EC Number:
- 202-414-9
- EC Name:
- 2-(2-heptadec-8-enyl-2-imidazolin-1-yl)ethanol
- Cas Number:
- 95-38-5
- Molecular formula:
- C18H34N2O - C24H46N2O
- IUPAC Name:
- 2-(2-heptadec-8-en-1-yl-4,5-dihydro-1H-imidazol-1-yl)ethanol
- Reference substance name:
- (Z)-2-(8-heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol
- EC Number:
- 244-501-4
- EC Name:
- (Z)-2-(8-heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol
- Cas Number:
- 21652-27-7
- Molecular formula:
- C22H42N2O
- IUPAC Name:
- 2-(2-heptadec-8-en-1-yl-4,5-dihydro-1H-imidazol-1-yl)ethanol
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- The substance contains 2% active ingredient
- Name of test material (as cited in study report): 81'004/B
- Lot/batch No.: Hu 139/1
- Substance type: organic
- Physical state: liquid
- Stability under test conditions: stable
- Storage condition of test material: room temperature
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy
- Age at study initiation: 10 weeks
- Weight at study initiation: 260 - 410 g
- Housing: individually in Macrolon cages type 3
- Diet: Standard guinea pig pellets - NAFAG No. 830, Gossau SG, ad libitum
- Water: Ad libitum
- Acclimation period:10 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 1° C
- Humidity: 50 +/- 10%
- Photoperiod: 14 hours light cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1% test substance solution dissolved in vehicle (test substance solution contains 2% active ingredient)
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline PhH VI
- Concentration / amount:
- 30% test substance solution dissolved in vehicle (test substance solution contains 2% active ingredient)
- Day(s)/duration:
- 48 h
Challengeopen allclose all
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1% test substance solution dissolved in vehicle (test substance solution contains 2% active ingredient)
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline PhH VI
- Concentration / amount:
- 30% test substance solution dissolved in vehicle (test substance solution contains 2% active ingredient)
- Day(s)/duration:
- 24 h
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: three weeks
- Test groups: During the induction period the animals received one injection every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1% solution of the test article (containing 2% of the active ingredient) in physiological saline. During the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant (vehicle : adjuvant = 1 : 1).
- Control group: One control group was treated with the vehicle alone.
- Site: On the first day, injections of 0.1 mL were administered into the shaved skin of the right flank and the back, while on the following days a single intracutaneous injection was given into the back.
- Concentrations: 0.1% of a 2% solution, i.e. 0.002%
B. CHALLENGE EXPOSURE
- No. of exposures: two (injection and epicutaneous application)
Fourteen days after the last sensitizing injection, a challenge injection of 0.1 mL of a freshly prepared 0.1% solution of the test article (containing 2% of the active ingredient) in physiological saline was administered into the skin of the left flank. 24 hours after the challenge injection the reactions were recorded. Ten days after the intracutaneous challenge injection a subirritant dose of the test compound (30% test material, containing 2% active ingredient, in vaseline) was applied epicutaneously under occlusive dressings which were left in place for 24 hours. The reactions were evaluated 24 hours after removing of the bandages according the Draize scoring scale. - Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- no data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.002%, intradermal (active ingredient)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: 0.1% test article, containing 2% active ingredient, equals 0.002% active ingredient
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.002%, intradermal (active ingredient)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: 0.1% test article, containing 2% active ingredient, equals 0.002% active ingredient
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.6%, epicutaneous (active ingredient)
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- other: 30% test article, containing 2% active ingredient, equals 0.6% active ingredient
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.6%, epicutaneous (active ingredient)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: 30% test article, containing 2% active ingredient, equals 0.6% active ingredient
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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