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Diss Factsheets

Administrative data

Description of key information

In guinea-pig maximization tests on DDBSA none of the test animals showed positive responses at 24 or 48 hours after removal of the challenge patches. DDBSA showed no sensitizing potential in guinea pigs.

A standard Buehler assay was conducted on AMP using guinea pigs. At both the 24 and 48 hours challenge, there was no evidence of inflammation indicative of a sensitising response. Under the circumstances of this study, AMP does not appear to be a skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Remarks:
the tested substance is AMP one of the components of the compound
Adequacy of study:
key study
Study period:
Not applicable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: meets generally accepted scientific standards, well-documented, and acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Buehler test (Patch-Test)
GLP compliance:
no
Type of study:
Buehler test
Justification for non-LLNA method:
LLNA test not available at the time of testing. Buehler test considered to be adequate data
Species:
guinea pig
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
Thirty male guinea pigs (250-300g each) were divided into 3 groups of 10 each. The animals' backs and flanks were shaved free of hair. The guinea pigs were topically treated with the solutions applied under an occlusive patch.
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction- 0.5ml of 10% (two doses) and 5% (remaining 8 doses) P-1826 solution Challenge- 0.5ml of 2.5% and 5% solutions of P-1826
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction- 0.5ml of 10% (two doses) and 5% (remaining 8 doses) P-1826 solution Challenge- 0.5ml of 2.5% and 5% solutions of P-1826
No. of animals per dose:
10
Details on study design:
One group was treated with 0.5mL of 10% P-1826 solution, a negative control group was treated with saline, and a positive control group was treated with dinitrochlorobenzene (DNCB solubilized in alcohol and made to volume with saline). After 24 hours, the patches were removed, and sites were cleaned and scored at 24 and 48 hours for erythema and edema according to Draize (Draize, JH, "Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics". Assoc. of Food and Drug Officials of the United States, p. 48, 1957). At 48 hours, the application was repeated with each group, and continued 2-3 times per week until 10 applications were made. Animals were allowed a 2 week recovery period, and then challenged at a virgin site. The test and negative control animals were challenged with 0.5mL of 2.5% and 5% solutions of P-1826. Positive and negative control animals were also challenged with 0.3% DNCB solution. After 24 hours, the test material was cleaned away, depilated, and three hours later scored for erythema and edema. Sites were scored again at 48 hours. Test material is considered a sensitizer if the challenge elicits skin reactions in a large number of test animals when compared to the negative control.
Challenge controls:
Positive and negative control animals were challenged with 0.3% dinitrochlorobenzene (DNCB) solution.
Positive control substance(s):
yes
Remarks:
dinitrochlorobenzene (DNCB solubilized in alcohol and made to volume with saline).
Positive control results:
During the induction, the positive control, DNCB, elicited a mild to strong reaction during the 10 applications. There was one death in the positive control group, but was deemed not treatment-related via necropsy due to the presence of a lung infection.Eight of ten positive controls when challenged with DNCB at 24 hours showed skin reactions, and 3/10 showed reactions at 48 hours.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.3%
No. with + reactions:
8
Total no. in group:
9
Clinical observations:
one animal died (not considered treatment related)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.3%. No with. + reactions: 8.0. Total no. in groups: 9.0. Clinical observations: one animal died (not considered treatment related).
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.3%
No. with + reactions:
8
Total no. in group:
9
Clinical observations:
one animal died (not considered treatment related)
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.3%. No with. + reactions: 8.0. Total no. in groups: 9.0. Clinical observations: one animal died (not considered treatment related).
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: negative control (DCNB)
Dose level:
0.3%
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: negative control (DCNB). Dose level: 0.3%. No with. + reactions: 4.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: negative control (DCNB)
Dose level:
0.3%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: negative control (DCNB). Dose level: 0.3%. No with. + reactions: 0.0. Total no. in groups: 10.0.

During the induction, the 10% P-1826 solution was found to be mildly irritating to all animals in the test group, so the remaining 8 doses during the induction were made with a 5% solution. 

The report only contains a summary of the results. This reproduced here:

Group II TEST

Group VI Positive Control

Group VIII Negative Control

Material

P-1826 (AMP)

DCNB

Saline

No. of animals

10

9a

10

Induction dose

10% (2 doses), 5% (8 doses)

0.3%

N/A

Challenge material

P-1826 (AMP)

DCNB

P-1826 (AMP)

DCNB

Challenge Dose or conc.

2.5%

5%

0.3%

2.5%

5%

0.3%

Time of skin reaction scoring

24

48

24

48

24

48

24

48

24

48

24

48

No. reacted/No. Challenged

0/10

0/10

0/10

0/10

8/9

3/9

0/10

0/10

0/10

2/10

4/10

0/10

a One animal died during the study of an unrelated lung infection

At challenge with 2.5% and 5% solutions of P-1826, none of the animals in the test or negative control groups showed any skin reactions at 24 hours, but the positive control animals showed mild skin reactions at 48 hours.


Interpretation of results:
GHS criteria not met
Conclusions:
2-Amino-2-methyl-1-propanol was a non-sensitizer in the topical sensitization test in guinea pigs, under these test conditions.
Executive summary:

A standard Buehler assay was conducted on AMP using 30 male guinea pigs. The animals were separated into 3 groups of 10 animals, a test group,a negative and positive control group. In the Induction phase of the study, the shaved backs and flanks of the test group were exposed to the test compound at a concentration of 10% for 24 hours under an occlusive dressing. At the end of this exposure period the test sites were cleaned and scored for irritation at 24 and 48 hours after exposure. At 48 hours, after the reading of skin irritation, the process was repeated until a total of 10 exposures had occurred. Due to the irritation (mild) caused by 10% test compound the 3rd through to the 10th exposures were done using a 5% concentration.

The positive and negative control groups followed the same procedure, but the animals were exposed to a 0.3% solution of Dinitrochlorobenzene (DNCB) or saline solution respectively.

At the Challenge phase, the test animals and the negative control animals were exposed for 24 hours to 2.5 and 5% test material at 2 previously untreated sites under an occlusive patch. After 24 hours the sites were cleaned and scored for signs of erythema and edema. The sites were scored again at 48 hours. The positive control group and the negative control group were challenged in the same way using a 0.3% concentration of DNCB.

One of the positive control group died during the study due to a lung infection. There were no other mortalities or signs of systemic toxicity observed. In the Test group, at both 24 and 48 hours there was no evidence of inflammation indicative of a sensitising response. In the positive control group 8 out of 9 animals and 3 out of 9 animals gave a positive response at 24 and 48 hours indicating that the positive control worked and that the study is valid. In the negative control group, there was no evidence of irritation or inflammation at the sites treated with the test compound. At 24 hours, 4 out of 10 animals displayed irritation following treatment with DNCB, this irritation had cleared at 48 hours.

Under the circumstances of this study, AMP does not appear to be a skin sensitiser.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Remarks:
the tested substance is DDBSA one of the components of the compound
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
other: Magnusson, B., and Kligman, A.M. (1969). The identification of contact allergens by animal assay. The guinea-pig maximization test. J. Invest. Dermat., 52, 268-276.
Principles of method if other than guideline:
an LLNA study does not need to be conducted because adequate data assessed with a different method at an earlier date is available
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
an LLNA study does not need to be conducted because adequate data assessed with a different method at an earlier date is available
Species:
guinea pig
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Porcellus Ltd., UK
- Weight at study initiation: 432-623 g
- Housing: 2-3 per cage of single sex, stainless steel cages with mesh floors, identified with colored body dye
- Diet (e.g. ad libitum): SG1 with vitamin C supplement, ad libitum
- Water (e.g. ad libitum): filtered tap water, ad libitum
- Acclimation period: 2 weeks

IN-LIFE DATES: From: September 5, 1983 To: October 21, 1983
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
intradermal induction: 0.05% m/v in corn oil
topical induction: 5% in corn oil
topical challenge: 2.5% in corn oil
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
intradermal induction: 0.05% m/v in corn oil
topical induction: 5% in corn oil
topical challenge: 2.5% in corn oil
No. of animals per dose:
10 animals per sex in test group
5 animals per sex in control group
Details on study design:
RANGE FINDING TESTS: The dorsal areas of two male and two females were closely short and shaved with an electric razor. 0.1 ml of several test dilutions were then injected. The concentrations tested were 0.05, 0.1, 0.5, and 1.0 %(m/v) of test substance in corn oil. These animals were observed for the next few days for toxicity. An additional two males and two females were exposed to 0.3 ml of 2.5, 5.0, 10.0, 20.0, and 50.0% of test substance in corn oil dermally for 24 hrs. At 24 and 48 hrs the animals were examined for signs of skin irritation.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two
- Test groups: The test group was first exposed by intradermal injection in the shoulder region. They were each given two injections of 0.1 ml each of Freund's complete adjuvant (FCA), 0.05% test substance in corn oil, and 0.05% of test substance in 50:50 FCA/corn oil. One week later, these same animals were given a dermal induction. The same area of skin was shaved. 0.3 ml of 5% test substance in corn oil was applied to a 4x4 cm2 patch of filter paper. This was applied to the skin and covered with Sleek dressing, which was then covered with Poroplast elastic adhesive bandage. Exposure was for 48 hrs.
- Control group: Control animals were treated in similar fashion with vehicle only.


B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: two weeks after the topical induction
- Exposure period: 24 hrs
- Test groups: 0.1 ml of 2.5% test substance in corn oil was placed on a 3x3 cm2 piece of filter paper. A similarly sized piece of adhesive tape was used to cover it, and secured with Poroplast elastic adhesive bandage. Patches were removed after 24 hrs.
- Control group: Control group was exposed in a similar fashion.
- Site: flank
- Evaluation (hr after challenge): Sites were evaluated immediately after removal, and at 24 and 48 hrs after removal. Sites were scored using the Draize scale.

Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5% in corn oil
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5% in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5% in corn oil
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5% in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2.5% in corn oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 2.5% in corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
2.5% in corn oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2.5% in corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0.

No animals showed a positive response at the 24 and 48 hr readings.

Results of Skin Sensitisation Study

Animal

0 hrs after challenge

24 hrs after challenge

48 hrs after challenge

Test Group

2908 M

0

0

0

2909 M

0

0

0

2910 M

0

0

0

2941 M

0

0

0

2943 M

0

0

0

2934 F

1

0

0

2935 F

0

0

0

2936 F

0

0

0

2977 F

0

0

0

2978 F

0

0

0

2918 M

0

0

0

2919 M

0

0

0

2920 M

1

0

0

2945 M

0

0

0

2946 M

1

0

0

2937 F

0

0

0

2938 F

0

0

0

2940 F

0

0

0

3001 F

1

0

0

3003 F

0

0

0

Control Group

2947 M

0

0

0

2948 M

0

0

0

2950 M

0

0

0

3024 M

0

0

0

2961 F

0

0

0

2963 F

0

0

0

2964 F

0

0

0

3004 F

0

0

0

3005 F

0

0

0

 

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is not sensitising to skin.
In a guinea-pig maximization test none of the test animals showed positive responses at 24 or 48 hours after removal of the challenge patches. The test material showed no sensitizing potential in guinea pigs.
Executive summary:

A group of 10 male and 10 female guinea pigs were used to determine the potential of the test substance to be sensitising to skin. The animals were first given an intradermal induction of 0.05% of test substance in corn oil. One week later, they were given a dermal induction of 5% test substance in corn oil. A group of 5 male and 5 female guinea pigs were used as controls. These animals were treated in a similar fashion with vehicle only. Two weeks after the dermal induction, a challenge was performed via dermal exposure to 2.5% test substance in corn oil. The control group was exposed as well. The animals were exposed for 24 hrs. Skin irritation readings were made at 24 and 48 hrs after the end of exposure. No positive responses were seen in either the test or control group. The test substance is not sensitising to skin.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Remarks:
the tested substance is DDBSA one of the components of the compound
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Directive 179/831 Annex, Part B.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
an LLNA study does not need to be conducted because adequate data assessed with a different method at an earlier date is available
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 200-350 g
- Housing: Makrolon cages, 5 per cage
- Diet (e.g. ad libitum): 8GP17 guinea pig food, ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 degree C
- Humidity (%): 60 +/- 20%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark
Route:
other: intracutaneously and epicutaneously
Vehicle:
water
Concentration / amount:
Induction concentration was 25% in water and Freund's Adjuvant; the challenge concentration was 12.5% in deionized water
Route:
other: no data
Vehicle:
water
Concentration / amount:
Induction concentration was 25% in water and Freund's Adjuvant; the challenge concentration was 12.5% in deionized water
No. of animals per dose:
10 male and 10 female
Details on study design:
Induction
Induction was first done by intradermal injection. Test animals were injected with 0.1 ml Freund Complete Adjuvant (FCA), 0.1 ml of 25% test substance in water, and 0.1 ml test substance in FCA in water (final concentration 25%). Control group was treated in a similar manner with only FCA and water. On day 7, a second, epicutaneous challenge was done. 0.5 ml of test susbtance (25%) was placed on gauze, and then placed on the animals. The animals were than bandaged, and the test substance remained in contact for 48 hrs. Control animals were exposed to vehicle only.

Challenge
0.2 ml of 12.5 % test article was placed on gauze, which was then placed on the test and control animals. Gauze containing only vehicle was placed on the left flank. The exposure lasted 24 hrs. Observations for irritation were made at 24 and 48 hrs after the end of exposure. Skin was scored for irritation using the Draize scale.
Positive control substance(s):
not specified
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.2 ml of 12.5% test solution
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no positive responses were observed
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 ml of 12.5% test solution. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no positive responses were observed.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.2 ml 12.5% test solution
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.2 ml 12.5% test solution. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
72
Group:
negative control
Dose level:
0.2 ml 12.5% test solution
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.2 ml 12.5% test solution. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0.2 ml 12.5% test solution
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.2 ml 12.5% test solution. No with. + reactions: 0.0. Total no. in groups: 10.0.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is not sensitizing to skin.
Executive summary:

This test determined the potential of the test substance to be sensitizing to skin. 10 male and 10 female guinea pigs were given intradermal injections of 25% test solution. Control animals (5 male and 5 female) were given injections of vehicle only. One week later, a second induction was done by dermal exposure to 25% test solution for 24 hrs. Control animals were again exposed to vehicle only. On day 21, the challenge exposure was performed. All animals were exposed to 12.5% test solution dermally. Exposure was for 24 hrs, with observations made at 48 and 72 hrs after the start of exposure. No positive reactions were noted. The test substance is not sensitizing.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the study results on DDBSA and AMP, the compound is considered not sensitizing to the skin. According to CLP (Regulation EC No 1272/2008) the substance does not need to be classified.