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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:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
older studies available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
DIPA, 99.61% pure was used.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
Male Hartley albino guinea pigs were used. Animals were clipped free of hair, on the left and right side (and may have been clipped on their back), the day prior to dosing.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction 50 % other: occluded with Hill TopChambers
Challenge 50 % other: occluded with Hill Top Chambers
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction 50 % other: occluded with Hill TopChambers
Challenge 50 % other: occluded with Hill Top Chambers
No. of animals per dose:
10
Details on study design:
Screen Phase
A preliminary skin irritation screen was conducted in order to determine a slightly irritating dose, if obtainable, as well as to establish the highest non-irritating concentration of the test material. Male Hartley albino guinea pigs were clipped free of hair, on the left and right side (and may have been clipped on their back), the day prior to dosing. A single application of 0.4 ml of 1, 10, 25, and 50% dose solutions of Diisopropanolamine (diluted with distilled water) was topically applied to the skin of guinea pigs for six hours in Hill Top Chambers (25 mm Hill Top Chamber, Hill Top Research Inc., Cincinnati, OH). The following day the application sites were depilated prior to scoring. Skin irritation readings were recorded approximately 24 and 48 hours after test material removal.

Induction Phase
The left side of ten male Hartley albino guinea pigs per treatment group were clipped free of hair the day prior to dosing. A single aliquot of 0.4 ml of 50% Diisopropanolamine (diluted with distilled water) was applied to the left side of ten male guinea pigs in Hill Top Chambers. A single aliquot of 0.4 ml of 10% DER 331 (CAS# 1675-54-3) epoxy in dipropylene glycol monomethyl ether (DPGME) was used as a positive control and applied in Hill Top Chambers to another group of ten male guinea pigs on weeks 1 and 2. On week 3, a single aliquot of 0.4 ml of 7.5% DER 331 in DPGME was applied to the positive control group. The chamber was secured with Vetrap which was held in place with Elastikon and removed after approximately a six hour exposure period. Observation for erythema/edema were recorded the following day. The animals were clipped and the respective groups were treated with the test material or positive control in the same manner at weekly intervals for a total of three consecutive weeks.

Challenge Phase
Approximately two weeks after the last induction application, the right side of the animals was clipped free of hair. The test material, a single aliquot of 0.4 ml of 50% Diisopropanolamine or 5% DER331 (positive control material) in DPGME, was applied to the right side of the guinea pigs in the same manner as in the induction phase. (Note- No data on naive animals was found in the study file.) The test material was removed after approximately a six-hour exposure period. The following day the challenge application sites were depilated prior to scoring. The application sites were observed and graded for sensitization response or irritation approximately 24 and 48 hours after the challenge application. The animals were observed at random, such that treatment group and naive animals were unknown. A material is considered a sensitizer if a positive response (erythema and/or edema scored to be 1.0 or greater) is observed following 48 hours after dosing in two or more of the challenge animals with no evidence of irritation in the naive animals.
Positive control substance(s):
yes
Remarks:
DER 331 (CAS# 1675-54-3)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none reported
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none reported.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none reported
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none reported.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
10% DER331
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
none reported
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 10% DER331. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: none reported.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
10% DER 331
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
none reported
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 10% DER 331. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: none reported.
Reading:
other: no details
Group:
negative control
Remarks on result:
other: no details

Any other information on results incl. tables

DIPA did not cause delayed contact hypersensitivity in guinea pigs.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
DIPA did not cause delayed contact hypersensitivity in guinea pigs.
Executive summary:

A sample of Diisopropanolamine (2 -propanol, 1,1'-iminodi-) was evaluated for acute dermal sensitization. Diisopropanolamine was evaluated for dermal sensitization potential using the Buehler method. Ten male Hartley albino guinea pigs received three dermal applications of 0.4 ml of 50% Diisopropanolamine (Diisopropanolamine in distilled water) during the three-week induction period. The animals received one application of 0.4 ml of 50% Diisopropanolamine during the challenge application two weeks after the last induction application. The condition of the test sites was assessed approximately 24 and 48 hours after the challenge application. Challenge application with 0.4 ml of 50% Diisopropanolamine did not cause erythema at the test site in any of the animals at the 48 hour read. Therefore, under the conditions of this study, Diisopropanolamine did not cause delayed contact hypersensitivity in guinea pigs.