Registration Dossier

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
Study period:
14 Dec 1998 - 31 Jan 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. (Limited documentation of induction and test substance; only 4 control animals due to sacrifice of one animal at day 21, challenge was done open and not occlusive.)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Magnussen and Kligmann Method
Deviations:
yes
Remarks:
Limited documentation of induction and test substance; only 4 control animals due to sacrifice of one animal at day 21, challenge was done open and not occlusive
Qualifier:
equivalent or similar to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
yes
Remarks:
Limited documentation of induction and test substance; only 4 control animals due to sacrifice of one animal at day 21, challenge was done open and not occlusive
GLP compliance:
yes (incl. certificate)
Remarks:
The Department of Health of the Government of the United Kingdom
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: straw colored liquid
- Analytical purity: no data
- Storage condition of test material: RT in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Hall Limited, Staffordshire, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 340 g-421 g
- Housing: individually housed in solid floor polypropylene cages furnished with woodflakes
- Diet: ad libitum Guinea Pig FD1 Diet, Special Diets Services Limited, Witham, Essex, UK)
- Water: ad libitum
- Acclimation period: at least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 44-57
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
arachis oil
Concentration / amount:
Induction: Intradermal induction 25%, epicutaneous induction 100%
Challenge: 100% and 75% (v/v) in arachis oil
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
arachis oil
Concentration / amount:
Induction: Intradermal induction 25%, epicutaneous induction 100%
Challenge: 100% and 75% (v/v) in arachis oil
No. of animals per dose:
10 (test groups)
4 (control group; initially 5, but 1 animal was sacrificed on Day 21)
Details on study design:
RANGE FINDING TESTS: Yes

Intradermal: Four concentrations of the test substance were investigated (1%, 5%, 10% and 25%) in a total of 4 guinea pigs. Each animal received four injections of 0.1 ml (only one concentration) and the skin reaction was assessed 24 h, 48 h, 72 h and 7 d afterwards according to Draize.

Topical: Two animals were pre-treated with an intradermal injection of FCA 17 days prior to test material administration.
Animals were administered four different concentrations (25%, 50%, 75% and 100%) of the test substance. Treatment was for 24 h under occlusive conditions and skin reaction was observed for dermal irritation 24 and 48 h afterwards.



MAIN STUDY
A. INDUCTION EXPOSURE
No further data available due to a loss of one page of the study report
- Concentrations: Intradermal induction: 25%, Topical induction: 100%


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 after topical induction
- Exposure period: 24 h
- Test groups: 1
- Control group: 1
- Site: Left (75%) and right (100%) flank
- Concentrations: 75% and 100%
- Evaluation (hr after challenge): 24 and 48 h after removal of the patches

Positive control substance(s):
yes
Remarks:
PEG 400 70:30 in Acetone

Results and discussion

Positive control results:
In the range of the historical controls

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
4
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: 4.0.
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:
1st reading
Hours after challenge:
24
Group:
test group
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:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
4
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: 4.0.
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:
2nd reading
Hours after challenge:
48
Group:
test group
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.

Any other information on results incl. tables

One control animal was sacrificed on Day 21 due to respiratory problems. The absence of this animal was considered not to affect the purpose or integrity of the study.

No skin reactions were noted at the challenge sites of the test or control animals at 24 h or 48 h observations.

Body weight gain of the test group was comparable to those observed in the control group animals.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified