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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and appropriate guidelines
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EPA OPP 81-6 (Skin Sensitisation)
Principles of method if other than guideline:
not relevant
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
At the time of conduct of this study, LLNA - OECD 429 did not exist.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Identity: PB-370
Physical description: Off white powder
Storage; room temperature
Reference No.: E7061-46

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Young adult Hartley guinea pigs were received from Hazelton Research Animals, Inc. Denver PA.
Diet: fresh tap water and Purina Guinea Pig Chow 5025 were given ad libitum.
Room temperature: 68-72 Deg F
RH: 32-78%
12 hr fluorescent light and 12 hr dark cycle.
Animal identification: ear tags and cage cards

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: saline
Concentration / amount:
Concentration of test material and vehicle used at induction:
neat test material (0.3g)

none

Concentration of test material and vehicle used for each challenge:
neat test material (0.3g)

none
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: saline
Concentration / amount:
Concentration of test material and vehicle used at induction:
neat test material (0.3g)

none

Concentration of test material and vehicle used for each challenge:
neat test material (0.3g)

none
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10
Details on study design:
see attached document on methods
Challenge controls:
See attached document on methods
Positive control substance(s):
not specified

Results and discussion

Positive control results:
n/a

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100 %
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: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
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: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
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: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
not measured/tested

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 100 %

Signs of irritation during induction:
No irritation

Evidence of sensitisation of each challenge concentration:
0

Other observations:
All animals remained healthy troughout the study. No
irritation was noted on any animal at any time during the
study.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information not classified
Conclusions:
The test material is judged to be non-sensitizing when topically applied to Hartley guinea pigs.
Executive summary:

PB-370 (0.30 gr) was applied topically to the left shoulders (previously clipped free of hair) of ten male and ten female Hartly guinea pigs. The test material was left in contact with skin for approx. six hours. The animals received three induction treatments one week apart. Fourteen days after the third induction treatment, the animals were challenged with test material at a virgin skin site. An additional five male and five female naive animals received 0.30 g of the test material (challange control group). Observations for skin reactions were recorded at 24 and 48 hr after each application. Body weights were recorded at initiation and termination.

All animals remained healthy throughout the study. No irritation was noted on any animal at any time during the study.

The test material is judged to be non-sensitizing when topically applied to Hartley guinea pigs.