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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: Read-across from supporting substance. Guideline and GLP study.
Cross-reference
Reason / purpose:
read-across source

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.6 (Skin Sensitisation)
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
study performed before 2002

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Crl:(HA)BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd, Manston Road, Margate, Kent, UK
- Age at study initiation: young adult
- Weight at study initiation: 300-457 g (m); 384-563 g (f)
- Fasting period before study: not applicable
- Housing: 2 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 +/- 2
- Humidity (%): 55 +/- 15
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: not available

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal - 0.03% in deionised water (test substance as supplied, containing 26.1% water)

Topical induction - 30% in deionised water (test substance as supplied, containing 26.1% water)

Concentration of test material and vehicle used for each challenge:
a) 30% in deionised water (test substance as supplied, containing 26.1% water)
b) 10% in deionised water (test substance as supplied, containing 26.1% water)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal - 0.03% in deionised water (test substance as supplied, containing 26.1% water)

Topical induction - 30% in deionised water (test substance as supplied, containing 26.1% water)

Concentration of test material and vehicle used for each challenge:
a) 30% in deionised water (test substance as supplied, containing 26.1% water)
b) 10% in deionised water (test substance as supplied, containing 26.1% water)
No. of animals per dose:
Number of animals in test group: 20 males
Number of animals in negative control group: 10 males
Positive control substance(s):
yes
Remarks:
hexylcinnamaldehyde

Results and discussion

Positive control results:
undiluted hexylcinnamaldehyde elicited a moderate skin sensitisation response.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
30%
No. with + reactions:
6
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: 30 %. No with. + reactions: 6.0. Total no. in groups: 20.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
1
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: 10 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
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: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30%
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: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
10%
Remarks on result:
not measured/tested
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
30%
Remarks on result:
not measured/tested
Remarks:
no data
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
30 %
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30 %. No with. + reactions: 6.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30%
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: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
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: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
10%
Remarks on result:
not measured/tested
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
30%
Remarks on result:
not measured/tested

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 30% (test substance as supplied, containing 26.1% water)

Signs of irritation during induction:
No irritation was noted following intradermal injections or
the topical application.

Evidence of sensitisation of each challenge concentration:
6/20 (30%) at 30%
2/20 (10%) at 10%

Applicant's summary and conclusion

Interpretation of results:
Category 1A (indication of significant skin sensitising potential) based on GHS criteria
Conclusions:
Under the test conditions of this study, ITC 826 Concentrate was considered as a skin sensitiser.
Executive summary:

The sensitisation potential of ITC 826 Concentrate was assessed using a method based on the maximisation test of Magnusson and Kligman (1970).

Challenge of previously-induced guinea pigs with a 30% w/v preparation of the test sample elicited a sensitisation response (30%) with an intradermal induction at 0.03%. Challenge of previously-induced guinea pigs with a 10% w/v preparation of the test sample elicited a mild sensitisation response (10%). In a positive control study, challenge of previously-induced guinea pigs with undiluted hexylcinnamaldehyde elicited a moderate skin sensitisation response, confirming the validity of the study.

Under the test conditions of this study, ITC 826 Concentrate should be classified into category 1A (H317) according to the CLP regulation (1272/2008) including ATP2 and a skin sensitizer (Xi; R43) according to the Directive 67/548/EEC criteria.