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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Buehler method
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Study performed before the implementation of the REACH regulation

Test material

Constituent 1
Chemical structure
Reference substance name:
Dipropyl peroxydicarbonate
EC Number:
240-211-7
EC Name:
Dipropyl peroxydicarbonate
Cas Number:
16066-38-9
Molecular formula:
C8H14O6
IUPAC Name:
1,1'-[dioxybis(carbonyloxy)]dipropane
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Sprague Dawley, lnc., Haslett, Michigan.
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known:
- Age at study initiation: no data
- Weight at study initiation: males 347-411 g, females 329-375 g
- Housing: individually in suspended stainless steel cages
- Diet: PMI Certified Guinea Pig Chow #5026 (Purina Mills, lnc.) was provided ad libitum
- Water: Municipal tap water treated by reverse osmosis was available ad libitum
- Acclimation period: a minimum of five days
- Indication of any skin lesions: no

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 60-72
- Humidity (%): 53-77
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
induction 1, day 0
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
75%
Day(s)/duration:
induction 2 and 3, days 6 and 13
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
0.5%
Day(s)/duration:
Day 27
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
0.75%
Day(s)/duration:
day 34
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Test: 10 males & females
Control: 5 males & females
Details on study design:
RANGE FINDING TESTS:
The test article was utilized at 100% and at 0.05%, 0.1 %, 0.25%, 0.5%, 1 %, 5%, 10%, 15%, 25%, 50% and 75% w/v in minerai oil for the range-finding studies.
Challenge controls:
no
Positive control substance(s):
yes
Remarks:
Hexylcinnamaldehyde

Results and discussion

Positive control results:
Using Hexylcinnamaldehyde as a positive control, Springborn Laboratories, lnc., Spencerville, Ohio, has completed a study during the past six months which provided historical control data for contact sensitization to this agent utilizing the test system described herein (Modified Buehler Design). Following induction at 15% and 10% w/v and challenge at levels of 2.5% and 5% (mild concentrations) w/v Hexylcinnamaldehyde, a contact sensitization response was observed, thereby demonstrating the susceptibility of the test system to this sensitizing agent.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
5%
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
5%
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
2.5%
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
2.5%
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
0.75%
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
0.75%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0.75%
No. with + reactions:
1
Total no. in group:
10
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
0.75%
No. with + reactions:
1
Total no. in group:
10

Any other information on results incl. tables

Topical Range-Finding Studies

The results of the range-finding studies indicated that a test article concentration of 100% produced moderate irritation and was considered appropriate for induction. A concentration of 0.5% w/v in minerai oil was the highest non-irritating concentration; therefore, this concentration was considered appropriate for challenge.

Sensitization Study

Following induction 1 with 100% Lupersol 221 dermal scores of 1 to 3 (some with very slight to slight edema, blanching, and/or eschar and one with necrosis) were noted on 19/20 test animals. Due to the severe response, the concentration was reduced to 75% for inductions 2 and 3. Dermal scores of 2 to 3 (all with very slight to slight edema and some with blanching, superficial lightening and/or eschar) were noted for all test animals at both induction 2 and 3. Following challenge with 100% mineral oil dermal scores of 0 to ± were noted for all control animals. Following challenge with 0.5% w/v Lupersol 221 in minerai oil, dermal scores of 0 to ± were noted in all test and control animals. Group mean dermal scores were noted to be similar in the test animals as compared with the control animals. Following rechallenge with 0.75% w/v Lupersol 221 in minerai oil, dermal scores of 1 were noted in 2/20 test animals and in 1/10 control animals at the 24 hour scoring interval. At the 48 hour scoring interval, dermal scores of 1 were noted in 1/10 control animals. Dermal reactions in the remaining test and control animals were limited to scores of 0 to ±. Group mean dermal scores were noted to be similar to the test animals as compared with the control animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Lupersol 221 is not considered to be a contact sensitizer in guinea pigs. The results of the Hexylcinnamaldehyde historical control study demonstrated that the test design utilized would detect potential contact sensitizers.
Executive summary:

The dermal sensitization potential of Lupersol 221 was evaluated in Hartley-derived albino guinea pigs. Ten male and ten female guinea pigs were topically treated with 100% Lupersol 221 (Induction I) or 75% w/v Lupersol 221 in mineral oil (Induction II and III), once per week, for three consecutive weeks. Five male and five female control guinea pigs were topically treated with 100% mineral oil, once per week for three consecutive weeks. Following a two-week rest period, a challenge was performed whereby the twenty test and ten control guinea pigs were topically treated with 0.5% w/v Lupersol 221 in mineral oil. Challenge responses in the test animals were compared with those of the control animals. Following a seven-day rest period, a rechallenge was performed whereby the twenty test animals and ten control guinea pigs were topically treated with 0.75% w/v Lupersol 221 in mineral oil. Rechallenge responses in the test animals were compared with those of the control animals. Lupersol 221: Following induction 1 with 100% Lupersol 221 dermal scores of 1 to 3 (some with very slight to slight edema, blanching, and/or eschar and one with necrosis) were noted on 19/20 test animals. Due to the severe response, the concentration was reduced to 75% for inductions 2 and 3. Dermal scores of 2 to 3 (all with very slight to slight edema and some with blanching, superficial lightening and/or eschar) were noted for all test animals at both induction 2 and 3. Following challenge with 100% mineral oil dermal scores of 0 to ± were noted for all control animals. Following challenge with 0.5% w/v Lupersol 221 in mineral oil, dermal scores of 0 to ± were noted in all test and control animals. Group mean dermal scores were noted to be similar in the test animals as compared with the control animals. Following rechallenge with 0.75% w/v Lupersol 221 in mineral oil, dermal scores of 1 were noted in 2/20 test animals and in 1/10 control animals at the 24 hour scoring interval. At the 48 hour scoring interval, dermal scores of 1 were noted in 1/10 control animals. Dermal reactions in the remaining test and control animals were limited to scores of 0 to ±. Group mean dermal scores were noted to be similar to the test animals as compared with the control animals.a-Hexylcinnamaldehyde: Usinga-Hexylcinnamaldehyde as a positive control, a study has been completed during the past six months which provided historical control data for contact sensitization to this agent utilizing the test system described herein (Modified Buehler Design). Following induction at 15% and 10% w/v and challenge at levels of 2.5% and 5% (mild concentrations) w/va-Hexylcinnamaldehyde, a contact sensitization response was observed, thereby demonstrating the susceptibility of the test system to this sensitizing agent. Based on the results of this study, Lupersol 221 is not considered to be a contact sensitizer in guinea pigs. The results of thea-Hexylcinnamaldehyde historical control study demonstrated that the test design utilized would detect potential contact sensitizers.