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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test

Test material

Constituent 1
Reference substance name:
25791-96-2
Cas Number:
25791-96-2
IUPAC Name:
25791-96-2
Constituent 2
Reference substance name:
Glycerol, propoxylated
EC Number:
500-044-5
EC Name:
Glycerol, propoxylated
IUPAC Name:
500-044-5
Constituent 3
Reference substance name:
Glycerol, propoxylated
IUPAC Name:
Glycerol, propoxylated
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 chemical
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 chemical
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.