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Diss Factsheets

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:
July 1 - August 10 1988
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:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4100 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The study was conducted before the protocol for the LLNA was in place (OECD adopted in 2002).

Test material

Constituent 1
Chemical structure
Reference substance name:
Dibutylamine
EC Number:
203-921-8
EC Name:
Dibutylamine
Cas Number:
111-92-2
Molecular formula:
C8H19N
IUPAC Name:
N-butylbutan-1-amine
Details on test material:
Di-n-butylamine

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, S. Brunswick, NJ
- Weight at study initiation: 332-448g
- Housing: 5 per suspended stainless steel cage
- Diet: Purina Guinea pig Pellets ad libitum
- Water: tap water ad libitum
- Acclimation period: 24 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9-22.2°C (66-72°F)

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Ethanol 80%
Concentration / amount:
6% in Ethanol 80%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Ethanol 80%
Concentration / amount:
6% in Ethanol 80%
No. of animals per dose:
10 males for the treated group
10 males for the negative control group
10 males for the positve control group
Details on study design:
RANGE FINDING TESTS: Determination of the non-irritating dose
Two guinea pigs were clipped on the thoracolombar region. 0.5ml of the test material as an 8% or 4 % solution in 80% Etahnol and as an 2 % or 1% solution in 60% Ethanol was applied. Each site was covered with a 2.5cm2 diameter gauze patch. After 6 hours of exposure, the patches were removed.
Readings were realised 24 hours later.
The highest non-irritating dose for induction was established to be 6% in 80 % Ethanol.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 6 hours/exposure
- Site: dorsal thoracolombar area
- Frequency of applications: once every 48 hours
- Concentrations: 6%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the last induction exposure
- Exposure period: 6 hours
- Site: dorsal thoracolombar area
- Concentrations: 6 %
- Evaluation (hr after challenge): at 24 and 48 hours
Challenge controls:
none
Positive control substance(s):
yes
Remarks:
Dinitrochlorobenzene 0.08% in 95% Ethanol

Results and discussion

Positive control results:
During induction period with DNCB, all guinea pigs exhibited erythema. Severity ranged from 0.5 (very faint, non-confluent) to 2.0 (moderate).
During challenge period with DNCB, six test sites were erythemateous 24 hours after challenge. Four sites were clear. At 48 hours , 8 sites had erythema and only 2 were clear. erythema scores ranged from 0.5 (very faint, non-confluent) to 3.0 (strong).

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.08%
No. with + reactions:
6
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.08%
No. with + reactions:
8
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
6%
No. with + reactions:
4
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
6%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
other: negative control 1
Dose level:
0%
No. with + reactions:
1
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
other: negative control 1
Dose level:
0%
No. with + reactions:
1
Total no. in group:
5
Reading:
1st reading
Hours after challenge:
24
Group:
other: negative control 2
Dose level:
0%
No. with + reactions:
2
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
other: negative control 2
Dose level:
0%
No. with + reactions:
2
Total no. in group:
5

Any other information on results incl. tables

Induction:

Faint non-confluent erythema which was sporadic and transient was observed throughout the induction period. Eschar, scabbing, and or skin discoloration were noted between the 5th and the 7th application. this did not re-occur when the test material was applied to an adjacent site.

Challenge:

Five sites exhibited wery faint non-confluent erythema 24 hours after challenge. the 5 remaining sites were clear. By 48 hours all challenged sites were clear. There was no evidence of oedema at either time interval.

in naive control guineapigs, one test site had very faint non-confluent erythema 24 and 48 hours after dosing. The 4 remaining previously naive sites were clear.

Individual results (challenge):

Sensitization scores -
Test substance		 Challenge score
Guinea pig N° 24h 48h Induced sensitization
2715 0,5 0 1+
2716 0 0 0
2717 0 0 0
2718 0 0 0
2719 0,5 0 1+
2720 0,5 0 1+
2721 0,5 0 1+
2722 0 0 0
2723 0 0 0
2724 0,5 0 1+
Naive control      
2725 0 0 0
2726 0 0 0
2727 0,5 0,5 1+
2728 0 0 0
2729 0 0 0

Sensitization scores -
control		 Challenge score
Guinea pig N° 24h 48h Induced sensitization
2715 0 0 0
2716 0 0,5 0
2717 1 1 1+
2718 2 1 2+
2719 2 1 2+
2720 3 2 3+
2721 0 0,5 0
2722 1 0,5 1+
2723 0,5 0,5 1+
2724 0 0 0
Naive control      
2725 0,5 0,5 1+
2726 0 0 0
2727 0 0 0
2728 0,5 0,5 1+
2729 0 0 0

Under these experimental conditions, the test substance is negative in the Buehler test.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A Bühler Test according to EPA OPPTS 870.2600 (Skin Sensitisation) was performed in male guinea pigs (Hartley). Under these experimental conditions, the test substance is negative in the Buehler test.
Executive summary:

A Bühler Test according to EPA OPPTS 870.2600 (Skin Sensitisation) was performed in male guinea pigs (Hartley). The guinea pigs were treated with 6 % of the test substance in 80% Ethanol epicutaneous (occlusive) for 6 hours. 10 males for the treated group, 10 males for the negative control group and 10 males for the positve control group (Dinitrochlorobenzene 0.08% in 95% Ethanol) were used.

RESULTS OF THE POSITIVE CONTROL:

During induction period with DNCB, all guinea pigs exhibited erythema. Severity ranged from 0.5 (very faint, non-confluent) to 2.0 (moderate). During challenge period with DNCB, six test sites were erythemateous 24 hours after challenge. Four sites were clear. At 48  hours , 8 sites had erythema and only 2 were clear. erythema scores ranged from 0.5 (very faint, non-confluent) to 3.0 (strong).

RANGE FINDING TESTS: Determination of the non-irritating dose

Two guinea pigs were clipped on the thoracolombar region. 0.5ml of the test material as an 8% or 4 % solution in 80% Etahnol and as an 2 % or 1% solution in 60% Ethanol was applied. Each site was covered with a 2.5cm2 diameter gauze patch. After 6 hours of exposure,  the patches were removed. Readings were realised 24 hours later. The highest non-irritating dose for induction was established to be 6% in 80 % Ethanol.

                           

MAIN STUDY

A. INDUCTION EXPOSURE

Guniea pigs were exposed 10fold to 6% of the test substance for 6 hours/exposure at the dorsal thoracolombar area site. The frequency of applications was once every 48 hours.

Faint non-confluent erythema which was sporadic and transient was observed throughout the induction period. Eschar, scabbing, and or skin discoloration were noted between the 5th and the 7th application. this did not re-occur when the test material was applied to an adjacent site.

                                  

B. CHALLENGE EXPOSURE

Guniea pigs were exposed 1fold to 6% of the test substance for 6 hours at the dorsal thoracolombar area site. The evaluation was performed 24 and 48 hours after the challenge.

Five sites exhibited wery faint non-confluent erythema 24 hours after challenge. the 5 remaining sites were clear. By 48 hours all challenged sites were clear. There was no evidence of oedema at either time interval.

in naive control guineapigs, one test site had very faint non-confluent erythema 24 and 48 hours after dosing. The 4 remaining previously naive sites were clear.

Under these experimental conditions, the test substance is negative in the Buehler test.