Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2000-02-02 to 2000-03-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Investigations performed were in conformance with the Directive 96/54/EC, B.6 and with the OECD Guideline 406. The guinea pig maximisation test was used as a well known and sensitive method.

Test material

Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor/CHFERT
- Expiration date of the lot/batch: June 2000

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the reefrigerator, in the dark
- Solubility and stability of the test substance in the solvent/vehicle: Unsoluble

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: HsdPoc:DH
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: Yes
- Microbiological status of animals, when known:
- Age at study initiation: 6 Weeks old
- Weight at study initiation: 347-432 g
- Housing: Makrolon cages type III
- Diet (e.g. ad libitum): Altromin Standard Diet No. 3022
- Water (e.g. ad libitum): Tap water
- Acclimation period: 2 weeks
- Indication of any skin lesions:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 48
- Air changes (per hr): 12/h
- Photoperiod (hrs dark / hrs light): 12
- IN-LIFE DATES: From: To:

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
5%/ 0.1mL
Route:
epicutaneous, occlusive
Vehicle:
acetone/olive oil (4:l v/v)
Concentration / amount:
100%
Day(s)/duration:
48 hours
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
acetone/olive oil (4:l v/v)
Concentration / amount:
50%
Day(s)/duration:
1
No. of animals per dose:
20 females
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 48
- Site: cranial, middle, caudal

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Site: Left flank for substance and right flank for vehicle
- Concentrations: 0.5 mL of test substance
- Evaluation (hr after challenge): 24 and 48 hr after exposure
Positive control substance(s):
yes

Results and discussion

Positive control results:
The last check was performed with Hexyl cinnamic aldehyde. 10 females were tested for the positive control substance group. 8/10 animals had a positive skin reaction.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
0.5 ml
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
positive control
Dose level:
10% in acetone
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

Cranial and caudal injection sites: Local irritations were observed in all animals beginning on the day after the injections.

Middle injection sites: 24 hours after induction exposure, no irritative reactions were observed in the negative control group, whereas very slight to severe erythema and oedema were noted in all animals of the test substance group.

All animals had severe erythema and oedema in the interscapular region which were attributed to the effects of the adjuvant.

All animals survived till the end of the study. Intradermal injections of Freund's adjuvant caused severe local reactions in all animals, a known effect of the adjuvant. The test substance affected autonomous nervous system (increased lacrimation) between Days 9 (i.e., after the end of the epicutaneous induction exposure) and 16. No other adverse effects were noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No animal of the test substance group (0/20) was regarded as sensitised. According to the Regulation (EC) 1272/2008 (CLP) the test substance is not considered to cause sensitisation by skin contact.