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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: 1a guideline study. Study was conducted in accordance to GLP and OECD guideline 406.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
A Buehler study was conducted according to OECD 406. Male and Female Dunkin Hartley guinea pigs (10 males and 10 females) received 0.5 undiluted test substance. Propoxylated glycerol mw 300 is not a skin sensitizer when tested using the Buehler technique.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: Propoxylated glycerol mw 300 (NLP) clear viscous liquid.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Hall Ltd, Staffs, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 307-399g

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: undiluted
Concentration / amount:
0.5 ml undiluted material
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: undiluted
Concentration / amount:
0.5 ml undiluted material
No. of animals per dose:
10 males and 10 females - Treated group
5 males and 5 females - Control group
Details on study design:
1st application: Induction undiluted occlusive epicutaneous
2nd application: Challenge undiluted occlusive epicutaneous
RANGE FINDING TESTS: A 6 hour occlusive application of 0.5 ml undiluted material did not cause any skin reaction at 24 or 48 hours.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hour
- Test groups: 2
- Control group: 1
- Site: Skin
- Frequency of applications: 1, 7 and 14 day
- Duration: 6 hours
- Concentrations: 0.5 ml undiluted material


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 6 hour
- Test groups: 2
- Control group: 1
- Site: Skin
- Frequency of applications: 28 day
- Duration: 6 hours
- Concentrations: 0.5 ml undiluted material
Positive control substance(s):
yes
Remarks:
2,4-DNCB

Results and discussion

Positive control results:
Report has included positive control data for the known contact sensitiser 2,4-DNCB carried out using a M&K maximisation procedure (presumably in error).

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.5 ml undiluted
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 ml undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.5 ml undiluted
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 ml undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
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. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
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. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Propoxylated glycerol mw 300 is not a skin sensitier when tested using the Buehler technique.