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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
Study period:
August-September 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well conducted study according to GLP
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
LLNA not adopted until 2002

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
429-320-2
EC Name:
-
Cas Number:
24748-23-0
Molecular formula:
C12H24O6
IUPAC Name:
3,6,9-triethyl-3,6,9-trimethyl-1,2,4,5,7,8-hexaoxonane
Details on test material:
Batch no. : 003513567
Storage: at room T in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
arachis oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
- Intradermal induction: 10% w/v in arachis oil BP - Topical induction: undiluted as supplied Concentration of test material and vehicle used for each challenge: Undiluted as supplied and 75% v/v in arachis oil BP
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
- Intradermal induction: 10% w/v in arachis oil BP - Topical induction: undiluted as supplied Concentration of test material and vehicle used for each challenge: Undiluted as supplied and 75% v/v in arachis oil BP
No. of animals per dose:
First study (106/031):
Number of animals in test group: 10
Number of animals in negative control group: 5
Second study (106/050):
Number of animals in test group: 10
Number of animals in negative control group: 5
Challenge controls:
yes
Positive control substance(s):
yes
Remarks:
mercaptobenzothiazole (149-30-4)

Results and discussion

Positive control results:
OK

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75 %
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: 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100 %
No. with + reactions:
7
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: 7.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75 %
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: 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
No. with + reactions:
5
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: 5.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

In the first study (106/031), at the challenge with undiluted (100%) test substance in both the test and the control animals effects of skin irritation were observed. Since these effects were observed in both test (8/10) and control (3/5) animals and
no effects whatsoever were observed in both test and control animals at the challenge concentration of 75% it was
concluded that owing to the irritancy of the 100% test material no sensitisation responses could be determined in
the 100% group. In the 75% challenge concentration no signs of irritation were observed. The test material was therefore
concluded not to cause sensitisation.

In the second report (106/050) it was, however, concluded that in the first study (106/031) 2/10 test animals showed a more severe reponse than the other animals and controls did. One of these two was killed for humane reasons 24 h after challenge (so that no data were available at 48 h).

As 5/10 (50%) of the animals showed slight skin reactions in the second study (106/050) at a challenge of 100% both at 24 h and 48 h after challenge, whereas controls did not, it was concluded that the overall sensitisation rate from these two studies was 7/20 (35%).

Signs of irritation during induction:
- Intradermal induction: Well defined to moderate to  severe erythema observed in all test group animals.
- Topical induction: Very slight to well-defined erythema with very slight oedema was noted in all test group animals at the 1 hour observation. In twelve test group animals very slight  to well-defined erythema was noted at the induction
sites after 24 hours.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Conclusions:
Under the conditions of the test, the test material produced a 50% (5/10) sensitisation rate. The results of this study can be collated with the results of the previous study (SPL Project Number 106/031) to give a total sensitization rate of 35% (7/20)
Executive summary:

Under the conditions of the test, the test material produced a 50% (5/10) sensitisation rate.  The results of this study can be collated with the results of the previous study (SPL Project Number 106/031) to give a total sensitization rate of 35% (7/20)