Registration Dossier
Registration Dossier
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EC number: 292-588-2 | CAS number: 90640-67-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug 1992 - december 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no test substance purity given
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Test was performed before LLNA method has to be used as first choice.
Test material
- Reference substance name:
- Amines, polyethylenepoly-, triethylenetetramine fraction
- EC Number:
- 292-588-2
- EC Name:
- Amines, polyethylenepoly-, triethylenetetramine fraction
- Cas Number:
- 90640-67-8
- Molecular formula:
- C6H18N4, C8H20N4
- IUPAC Name:
- Amines, polyethylenepoly-, triethylenetetramine fraction
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Buckberg Lab Animals, Tomkins Cove, New York
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 301-369g
- Housing: individually in stainless steel wire mesh cages
- Diet (e.g. ad libitum): purina guinea pig diet, ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 5 Dec 1992 To: 12 Dec 1992 (Dose-Range-Finding)
IN-LIFE DATES: From: 14 Dec 1992 To: 13 Jan 1993 (Assay)
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 80% ethanol
- Concentration / amount:
- 0.3 mL/site (70%)
- Day(s)/duration:
- 3 inductions, one week in between, 6 h exposure duration
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 0.3 mL/site (50%)
- Day(s)/duration:
- 1 and 2
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- dose range finding: 12 (6 males, 6 females)
test article: 20 (10 males, 10 females)
positive control: 5 (3 males, 2 females)
negative control: 10 (5 males, 5 females) - Details on study design:
- RANGE FINDING TESTS:
2 males, 2 females: each animal is exposed to 4 different concentrations: 1%, 10%, 50%, 100%; 80% ethanol as the vehicle.
1 male, 1 female: each animal is exposed to 4 different concentrations: 60%, 70%, 80%, 90%; 80% ethanol as the vehicle.
2 males, 2 females: each animal is exposed to 4 different concentrations: 1%, 10%, 50%, 90%; acetone as the vehicle
1 male, 1 female: each animal is exposed to 4 different concentrations: 20%, 30%, 40%, 50%; acetone as the vehicle
primary challenge responses were graded
Highest non-irritatting concentration = concentration that induced responses not exceeding 2 + and 2 0 grades in the group of 4 animals.
the dose chosen for induction: 70%
the dose chosen for challenge: 50%
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 4 (3 inductions, 1 challenge)
- Exposure period: -
- Test groups: test substance in vehicle (80% ethanol)
- Control group: vehicle only (80% ethanol)
- Site: L shoulder (1st and 2nd induction), R shoulder (3rd induction)
- Frequency of applications: once a week
- Duration: 6 h
- Concentrations: 70%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 29
- Exposure period: -
- Test groups: test substance in vehicle (aceton)
- Control group: vehicle (aceton) only (left flank), test article (right flank)
- Site: naive site on left flank
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48h
Other:
24h after challenge and rechallenge, all animals were depilated with Neet Cream Hair Remover (Whitehall Laboratories, Inc., New York). A minimum of 2h after depilation test sites were graded. The grading was repeated 24h later (48h grade).
All animals were euthanized by CO2 inhalation at study termination. - Challenge controls:
- The negative control group was challenged with vehicle (aceton) on the left flank and test article on the right flank.
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene
Results and discussion
- Positive control results:
- Sensitising effects observed in all 5 animals of the positive control group.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 70% induction, 50% challenge
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- severity= 2.2
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 70% induction, 50% challenge
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- severity= 2.4
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- severity= 0.0
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- severity= 0.0
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.3% challenge
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- severity= 3.0
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.3% challenge
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- severity= 3.0
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
The results above on the test group have been corrected, based on the raw data presented in the study.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS Category 1B (H317) according to Regulation (EC) No 1272/2008
- Conclusions:
- Based upon the observations made in the assay, the test article (induction and challenge concentrations 70% and 50%, respectively), caused delayed contact hypersensitivity in guinea pigs.
- Executive summary:
A Buehler test for skin sensitisation with the test substance was carried out in guinea pigs. Based on preliminary testing, the concentration chosen for induction was 70% and the concentration chosen for challenge 50% (occlusive applications). At the first reading (24 h after challenge), 18/20 animals showed skin reactions; at the second reading (48 h after challenge), 19/20 animals were positive. It was concluded that the test substance is a skin sensitiser.
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