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Toxicological information

Skin sensitisation

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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:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
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

Reference
Name:
Unnamed
Type:
Constituent
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
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 group
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 group
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.