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Registration Dossier
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EC number: 944-170-2 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1980-09 to 1980-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- No data on positive control.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Guinea pig maximization test as described by B. Magnusson and A.M. Kligman (1970), the later released OECD Guideline 406 (1981) is based to a great extent on this publication.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid GPMT conducted comparable to guideline with acceptable restrictions is available, which is reliable with restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. Moreover, no indication for skin sensitisation was observed in this study, thus, no dose response information is needed. For this reason and for reasons of animal welfare no additional LLNA was conducted.
Test material
- Reference substance name:
- 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18(even numbered) and C18 unsaturated acyl) derivs., hydroxides, inner salts
- EC Number:
- 931-333-8
- Cas Number:
- 147170-44-3
- Molecular formula:
- not applicable
- IUPAC Name:
- 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18(even numbered) and C18 unsaturated acyl) derivs., hydroxides, inner salts
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- dihydrogen oxide
- Test material form:
- solid - liquid: aqueous solution
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 400 +/- 50 g
- Housing: suspended cages
- Diet: ad libitum, Guinea-pig diet (Ssniff G)
- Water: ad libitum, tap water
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5 % RH
- Air changes (per hr): 16
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction:
Intradermal injection:0.5 % v/v,
Topical application after 7 days: epicutaneous 60 % v/v - Day(s)/duration:
- 1 week after injections; topical application 48 h
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Challenge: 10 % v/v
- Day(s)/duration:
- 2 weeks after the induction; 24 h exposure
- No. of animals per dose:
- 15 test animals,
5 control animals - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 times
- Exposure period: 0 and 1 week after injections topical application for 48 h
- Test groups: 15
- Control group: 5
- Site: a 4 x 6 cm area of dorsal skin on the scapular region was clipped free of hair.
First stage:: 3 pairs of intradermal injections were made simultaneously. A volume of 0.1 ml was injected into both infection sites (left and right site)
- Concentrations:
Test group:
1. 0.1 ml of Freund´s complete adjuvant 50 : 50 with water for injection
2. 0.1 ml of 0.5 % v/v test item in sterile isotonic saline
3. 0.1 ml of 0.5 % v/v test item in a 50 : 50 mixture of isotonic saline and Freund´s complete adjuvant
Control group:
1. 0.1 ml of Freund´s complete adjuvant 50 : 50 with water for injection
2. 0.1 ml of sterile isotonic saline
3. 0.1 ml of Freund´s complete adjuvant 50 : 50 with isotonic saline
Control animals: during the induction period control animals were treated similarly to the test animals but the test substance was omitted form intradermal injections and topical applications.
Second stage: 7 days after the first induction the same area was clipped and shaved free of hair. A 2 x 4 cm patch of filter paper was saturated with 60 % v/v test item in distilled water. Patch was placed on the skin and covered by a impermeable plastic adhesive tape ("Dermicel"). Tape
was secured by a elastic adhesive bandage ("Elastoplast"). Occulsive dressing was left in place for 48 h.
B. CHALLENGE EXPOSURE
- No. of exposures: 1 time
- Day(s) of challenge: 2 weeks after the induction
- Exposure period: 24 h
- Test groups:
2 x 2 cm filter paper was saturated with the test sample in a similar as used for second stage induction. Occlusive dressing for 24 h.
- Control group: The 5 animals of the control group were similarly challenged
- Site: hair was removed by clipping and then shaving a 5 x 5 cm area on the left flank.
- Concentrations: 10 % v/v test item in distilled water
- Evaluation (hr after challenge): 24, 48, 72 h after patch removal
Scoring:
Erythema and eschar formation:
No erythema 0
Slight erythema (barely perceptible): 1
Well-defined erythema 2
Moderate erythema 3
Severe erythema (beet. redness) to slight eschar formation (injuries in depth) 4
Oedema formation:
No oedema 0
Slight oedema (barely perceptible): 1
Well-defined oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised app. 1 mm 3
Severe oedema (raised more than 1 mm and extending beyond the area 4
of exposure
- Challenge controls:
- 5
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 2
- Total no. in group:
- 15
- Clinical observations:
- erythema score 1 (Slight erythema (barely perceptible))
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
Any other information on results incl. tables
Induction:
Intradermal injections containing Freund´s complete adjuvant: elicited well-defined dermal irritation
Intradermal injection of 0.5 % v/v test item in all test animals: temporary slight dermal irritation
Second stage (topical application) of 60 % v/v test item:slight dermal reactions
Challenge (10 % v/v Test item):
Test animals:
After 24 h: slight erythema (1): 2 animals
Control animals: no reactions
All animals (test and control animals) showed slight bandage reactions
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- In this guinea-pig maximization test, performed in 20 albino guinea-pigs, Coco AAPB (30 % a.i.) did not produce evidence of delayed contract hypersensitivity.
- Executive summary:
In a dermal sensitization study with Coco AAPB (commercial product) 20 male Pirbright white guinea pig were tested using the MAXIMIZATION TEST described by b. Magnusson and A.M. Kligman (1970). The test method is similar to OECD Guideline 406 (Skin Sensitisation).
The analytical purity of the test item is not stated in study report, according to producer information test material has 30 % a.i., impurities relevant to sensitisation and referred to a.i. are 8.3 % Alkylamidopropylamine and 33 -50 ppm DMPA (3-dimethylaminopropylamine).
At the first scoring, 24 h after challenge, 2/15 showed a skin reaction score 1 (slight erythema (barely perceptible)). The animals were free of erythema and edema at the second (48 h) and the third (72 h) scoring. None of the five negative animals showed up to and including the third scoring a positive skin reaction to challenge treatment.
In this study, Coco AAPB (30 % a.i.) is not a dermal sensitizer.
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