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Registration Dossier
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EC number: 500-105-6 | CAS number: 39423-51-3 1 - 6.5 moles propoxylated
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987-05 to 1987-06
- 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:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Experiment performed according to the OECD 406 guideline adopted in 1981, which is intended primarily for use with guinea pig.
Test material
- Test material form:
- liquid
- Details on test material:
- Name of test material: Trimethylolpropanepoly(oxypropylene)triamine
EC no.: 500-105-6
CAS no.: 39423-51-3
Physical state: clear colourless liquid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under test conditions: no apparent change in the physical appearance of the test article during administration
OTHER SPECIFICS:
- Name of test material (as cited in study report): 5601-88-1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hazelton Research Products, Inc., Denver, Pennsylvania
- Weight at study initiation: 300-600g
- Housing: two per cage, wire mesh cages.
- Diet (e.g. ad libitum): Wayne Guinea Pig Diet, ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: May 28, 1987 To: June 27, 1987
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 80% ethanol
- Concentration / amount:
- 0.4ml per site
first induction: 70%
second and third induction: 40%
challenge 40%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 80% ethanol
- Concentration / amount:
- 0.4ml per site
first induction: 70%
second and third induction: 40%
challenge 40%
- No. of animals per dose:
- dose range: 6
test article: 20 (10 male, 10 female)
positive control: 6 (3 male, 3 female)
negative control: 10 (5 male, 5 female)
naive: 4 (2 male, 2 female) - Details on study design:
- 2 RANGE FINDING TESTS:
3 males, 3 females: each animal is exposed to 4 different concentrations of the test material (1%, 10%, 25%, 100%): 80% ethanol as the vehicle.
1 male, 1 female: each animal is exposed to 4 different concentrations of the test material (50%, 60%, 70%, 80%): 80% ethanol as the vehicle
primary challenge responses were graded
Highest non-irritatting concentration = concentration in vehicle 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: 40%
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 4 (3 inductions, 1challenge)
- Exposure period: -
- Test groups: test substance in vehicle (80% ethanol)
- Control group: vehicle only
- Site: L shoulder (first induction); R shoulder (second and third induction)
- Frequency of applications: once a week
- Duration: 6 h
- Concentrations: 70% (first induction); 40% (second and third induction)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 29
- Exposure period: -
- Test groups: test substance in vehicle
- Control group: vehicle only
- Site: naive site on left flank
- Concentrations: 40%
- Evaluation (hr after challenge): 24 and 48h
OTHER:
24h after challenge, 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). - Challenge controls:
- Four naive animals (2 males, 2 females) were induced with the test material (40% concentration) on challenge day in the same manner as the test group and control groups.
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene
Results and discussion
- Positive control results:
- Sensitising effects were observed in all six animals of the positive control group.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- severity= 0.1
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- severity= 0.1
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 3
- Total no. in group:
- 9
- Clinical observations:
- severity= 0.4
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 1
- Total no. in group:
- 9
- Clinical observations:
- severity= 0.2
- Key result
- Reading:
- other: naive control
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- severity= 0.0
- Key result
- Reading:
- other: naive control
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- severity= 0.1
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.3%
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Clinical observations:
- severity= 3.0
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.3%
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Clinical observations:
- severity= 3.0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the observations made in the assay, the test article induced at 70% (1st) and 40% (2nd and 3rd) and challenged at a 40% concentration, did not cause delayed contact hypersensitivity in guinea pigs.
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