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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, predates GLP, available as unpublished report, minor limitations in reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: method of Maguire (1973)
Principles of method if other than guideline:
test animals: male Hartley albino guinae pigs. Group housing, acclimated 1 week before testing.
There were 2 groups, one a positve control goup, the other group was an test group
The test group recieved 4 applications of10% solution of PO in Dowanol DPM/Tween 80 and was applied on a gauze square and covered by tape
The positive control group recieved DER 331 epoxy resin as a 10% solution in DOWANOL DPM/ Tween 80 in the same way as the test group.
After 2 days there was a second application. At the time of the third application 0.2 ml of Freund's Adjuvant was injected intradermally adjecent to the insult site.
E very time the patches were removed, observations about primary irritation were made and recorded. After two weeks of rest the animals were challenged and the skin response was scored 24 and 48 hours after the challenge.
GLP compliance:
not specified
Type of study:
split adjuvant test
Justification for non-LLNA method:
The study was conducted prior to new OECD guidance making the LLNA – method mandatory.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): propylene oxide (also known as methyl oxirane).
-Source: Dow chemicals'Texas division, freeport Texas.
-lot nr: TB-820513

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Buckberg Lab Animals, Inc., Tomkins Cove, New York
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: group housing, 5/cage
- Diet : ad libitum
- Water: ad libitum
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 /12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Dowanol DPM/Tween 80 (9:1)
Concentration / amount:
10% solution
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: Dowanol DPM/Tween 80 (9:1)
Concentration / amount:
10% solution
No. of animals per dose:
10
Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 4
- Exposure period: 48 hours
- Test groups: yes
- Control group: yes
- Site: flanks
- Frequency of applications: once every 2 days
- Duration: 8 days
- Concentrations: 0.1 ml of 10 % solution PO


B. CHALLENGE EXPOSURE
animals were allowed to rest for 2 weeks
- No. of exposures: once
- Day(s) of challenge: 1 day
- Exposure period: 24 and 48 hours
- Test groups: yes
- Control group: yes
- Site: flanks
- Concentrations: 0.1 ml of 10 % solution PO
- Evaluation (hr after challenge): 24 and 48 hours

Challenge controls:
Dowanol DPM/Tween 80
Positive control substance(s):
yes
Remarks:
DER 331 epoxy resin as a 10% solution in DOWANOL DPM/Tween (9:1)

Results and discussion

Positive control results:
A positive response was observed on 8 of 10 guinea pigs treated with DER 331 epoxy resin

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10%
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: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
10%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 10%. No with. + reactions: 8.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
10%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 10%. No with. + reactions: 8.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information