Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Report of study available. Not to GLP and not as fully documented as ideally required but in sufficient detail to judge results as reliable
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Remarks:
, none noted
Principles of method if other than guideline:
Magnusson and Kligman. Followed company standard operating procedure 011/02.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Butyl dioxitol
- Physical state: clear colourless liquid
- other: lab reference no: 14547T1

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation males: 320-360g. Weights at end: 424-490
- Weight at study initiation males: 340-350g. Weights at end: 402-480
- Diet: ad libitum RGP pellets, hay, cabbage
- Water: ad libitum

IN-LIFE DATES: From: 27.11.85 To: 2.1.85

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
2.5% for induction exposure but challenge exposure used undiluted.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
2.5% for induction exposure but challenge exposure used undiluted.
No. of animals per dose:
10
Details on study design:
RANGE FINDING TESTS
Preliminary experiments for the intradermal injection (4 females) established that 2.5% was the maximum concentration that could be tolerated without excessive irritation (odema). An occluded patch preliminary test established that epicutaneous occluded exposure to neat material could be tolerated without any adverse reaction.

MAIN STUDY
Sensitisation induced by intradermal injections of both test substance and Freund's Complete Adjuvant. The induction process was supplemented 6-7 days later by test substance applied to the shoulder injection sites under occlusion. 12-24 days later the animals were challenged by occluded patch. A further challenge was made one week later. Challenge patches were applied for 24hours and reaction sites examined at 24 and 48 hours
Challenge controls:
'Treated' negative controls used (all male) at both challege time points.
Positive control substance(s):
no

Study design: in vivo (LLNA)

Statistics:
not applicable

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
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: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
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: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
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: 10.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
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: 10.0.
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.
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.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
No evidence of sensitisation
Executive summary:

A study was carried out which broadly followed the requirements of a guideline M&K skin sensitisation study. The study showed no evidence that 2 -(2 -butoxyethoxy)ethanol causes adverse skin sensitisation reactions.

Synopsis

Not sensitising