Registration Dossier

Administrative data

Description of key information

FAT 40147 is not a skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
None
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted May 12, 1981
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
Directive 84/449
Deviations:
no
Principles of method if other than guideline:
None
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This study was carried out in 1990.
Specific details on test material used for the study:
Identification: FAT 40'147/F
Description: red, solid
Batch Number: Op. 1/1990
Stability of test article: expiration date: March 1992
Stability of test article dilutions: stable for at least 48 hours in the solvents used
Storage Conditions: in the original container, protected from light, at approximately +20°C
Safety precautions: Gloves, goggles and face mask were sufficient to assure personnel health and safety.
Species:
guinea pig
Strain:
other: Ibm: GOHI; SPF-quality guinea pigs (synonym: Himalayan spotted)
Sex:
male/female
Details on test animals and environmental conditions:
Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Fullinsdorf

Total Number of Animals per Test: 15 males, 15 females

Age at Acclimatization Start: males : 7 weeks, females: 8 weeks

Body Weight at Acclimatization Start: males: 304 - 384 g, females: 337 - 404 g

Identification: By unique cage number and corresponding ear tags.

Randomization: Randomly selected at time of delivery.

Acclimatization: One week under test conditions after veterinary examination.

The animals were distributed as follows: 5 males, 5 females for the control group and 10 males, 10 females for the test group.

Standard Laboratory Conditions:
Air-conditioned with 10-15 air changes per hour and hourly monitored environment with temperature 22 ± 3 °C, relative humidity 40-70 %, 12 hours artificial fluorescent light/12 hours dark, music during the light period.

Accommodation:
Individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).

Diet
Pelleted standard Kliba 342, Batch 57/90 guinea pig breeding/ maintenance diet ("Kuba", Klingentalmühle AG, CH-4303 Kaiseraugst), ad libitum. Results of analysis for contaminants are included in this report.

Water
Community tap water from Itingen, ad libitum. Once weekly additional supply of ascorbic acid via the drinking water.
Route:
intradermal
Vehicle:
other:
Concentration / amount:
5 % test item in Freund's complete adjuvant and physiological saline (1:1) / 0.1 ml
Day(s)/duration:
Week 1
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
other: petrolatum-oil
Concentration / amount:
25 %
Day(s)/duration:
Week 2
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: petrolatum-oil
Concentration / amount:
25 %
Day(s)/duration:
Week 4
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
The test was performed on 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group, respectively,
Details on study design:
RANGE FINDING TESTS:
The following concentrations of FAT 40138/D have been examined on separate animals for the determination of the maximum subirritant concentration: 1, 5, 10, 20, 30, and 50% in vaseline.
Erythema reactions were observed with 20, 30, and 50 % FAT 40138/D in vaseline.

MAIN STUDY
A. INDUCTION EXPOSURE - INTRADERMAL
- No. of exposures: 1
- Exposure period: Intradermal injection
- Test groups: 1
- Control group: 1
- Site: shaved neck
- Frequency of applications: once
- Duration: -
- Concentrations: 5 %

A. INDUCTION EXPOSURE - EPIDERMAL
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: 1
- Control group: 1
- Site: neck
- Frequency of applications: once
- Duration: 48 hours
- Concentrations: 25 %

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Week 4
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: flank
- Concentrations: 25 %
- Evaluation (hr after challenge): 24
Positive control substance(s):
yes
Remarks:
solution of formaldehyde
Positive control results:
1) In the study with FORMALDEHYDLOESUNG (HCHO) 70 % of the animals were positive at 24 hours after treatment.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0
No. with + reactions:
0
Total no. in group:
20

TEST GROUP:

No positive reactions were evident after the first challenge application, neither when treated with the vehicle alone nor when treated with the test article diluted to 25 % in petrolatum-oil.

MORTALITY / VIABILITY:

One died spontaneously on day 22 of test.

SYMPTOMS, SYSTEMIC:

No systemic symptoms were observed during the study.

BODY WEIGHTS:

The body weight gain of the animals was not affected adversely during the study.

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40147/F is not a skin sensitiser.
Executive summary:

The sensitisation potential of the test substance was evaluated in a study conducted according to the maximisation test described in OECD Guideline 406 and EU Method B.6, in compliance with GLP. Five males and 5 females were used in the control group and 10 males and 10 females were used in the test group. Intradermal and epidermal inductions were carried out in week 1 and week 2 at 5 and 25 % test concentrations, respectively. The test and control guinea-pigs were challenged in week 4 with the epidermal application. The test concentration used for challenge was 25 %. Approximately 24 and 48 hours after the removal of the dressing the application sites were assessed for erythema and oedema using the numerical scoring system according to Draize. None of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. Hence, FAT 40147/F is not a skin sensitiser.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a key study, the sensitisation potential of the test substance was evaluated according to the maximisation test described in OECD Guideline 406 and EU Method B.6, in compliance with GLP. Five males and 5 females were used in the control group and 10 males and 10 females were used in the test group. Intradermal and epidermal inductions were carried out in week 1 and week 2 at 5 and 25 % test concentrations, respectively. The test and control guinea-pigs were challenged in week 4 with the epidermal application. The test concentration used for challenge was 25 %. Approximately 24 and 48 hours after the removal of the dressing the application sites were assessed for erythema and oedema using the numerical scoring system according to Draize. None of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. Hence, FAT 40147/F is not a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of a maximisation test, FAT 40147 is does not warrant classification according to CLP (regulation 1272/2008) criteria.