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Diss Factsheets

Administrative data

Description of key information

FAT 31064/F was considered to be 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:
Test start date: 15 January, 1990; Test end date: 01 March, 1990; Study completion date: 31 May, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted May 12, 1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Data from a reliable in vivo test conducted before the enforcement of Commission Regulation (EU) 640/2012 of 06 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are available.
Specific details on test material used for the study:
Identified as: FAT 31064/F
Description: Powder
Batch Number: EN 158496.82 / HEW 133/6
Stability of test article: stable; Expiration date: November 1994
Stability of test article dilution: Stable for at least 2 hours
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
Sex:
male/female
Details on test animals and environmental conditions:
Test System
The albino guinea pig is the recommended species for skin sennsitization studies.
- Source: BRL, Biological Research Laboratories Ltd., Wolferstrasse 4, CH-4414 Füllinsdorf
- Total Number of Animals per Test: 15 males and 15 females
- Age at acclimatization start: males: 7 weeks, females: 8 weeks
- Body Weight at Acclimatization Start: males: 401 - 479 g; females: 353 - 449 g
- Acclimatization: One week under test conditions after veterinary examination.

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

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

- Diet: Pelleted standard Kliba 342, Batches 55/89 and 56/90 guinea pig breeding/maintenance diet ("Kliba", Klingentalmühle AG, CH-4303 Kaiseraugst), ad libitum.

- Water: Community tap water from Itingen, ad libitum.
Route:
intradermal
Vehicle:
other: ethanol
Concentration / amount:
5%
Day(s)/duration:
At the start
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
other: Ethanol
Concentration / amount:
25%
Day(s)/duration:
one week after intradermal induction
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
25 %
Day(s)/duration:
Two weeks after the epidermal induction
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
25%
Day(s)/duration:
Two weeks after the first challenge
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 males and 10 females for test group
5 males and 5 females for control group
Details on study design:
RANGE FINDING TESTS:
A preliminary study was performed to identify irritant test article concentrations suitable for the induction phase of the main study. In addition, a suitable non-irritant concentration of the test article, by the topical route of administration, was identified for the challenge application.

MAIN STUDY
A. INDUCTION EXPOSURE (Intradermal induction)
- No. of exposures: 1
- Test groups: 1
- Control group: 1
- Site: shaved neck
- Frequency of applications: once
- Concentrations: 5%

B. INDUCTION EXPOSURE (Epidermal induction)
- No. of exposures: 1
- Test groups: 1
- Control group: 1
- Site: neck of the animals
- Frequency of applications: once
- Duration of exposure: 48 h
- Concentrations: 25% (with prior application of SDS 10%)

C. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after epidermal induction
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: flank
- Concentrations: 25%
- Evaluation (hr after challenge): 24 h after removing the dressing

D. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after first challenge
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: flank
- Concentrations: 25%
- Evaluation (hr after challenge): 24 h after removing the dressing
Positive control substance(s):
yes
Remarks:
Formaldehyde
Positive control results:
9/10 rats showed positive reactions after first challenge exposure.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Intradermal induction: 5%, Epidermal induction: 25%, challenge: 25%
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Intradermal induction: 5%, Epidermal induction: 25%, challenge: 25%
No. with + reactions:
5
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
Intradermal induction: 5%, Epidermal induction: 25%, challenge: 25%, rechallenge: 25%
No. with + reactions:
5
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
Intradermal induction: 5%, Epidermal induction: 25%, challenge: 25%, rechallenge: 25%
No. with + reactions:
4
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle only
No. with + reactions:
0
Total no. in group:
10
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
vehicle only
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
20% Epidermal, 15% Challenge
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

Mortality: No death occurred during the study.

Systemic symptoms: 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 31064/F was considered to be not a sensitiser to skin.
Executive summary:

The skin sensitisation potential of FAT 31064/F has been investigated in a study conducted using Magnusson and Kligman maximation method as described in OECD Guideline 406. In this study, a group of guinea pigs containing 10 males and 10 females, received FAT 31064/F at 15 % concentration in the intradermal induction phase and at 25 % concentration during the epidermal induction phase. The day before epidermal induction, the application sites were pretreated with 10 % sodium lauryl sulfate as open application. Two weeks after the epidermal induction application the animals were challenged with the occluded epidermal application for 24 hours on the flank with FAT 31064/F (concentration 25 %) in ethanol and the vehicle alone. A second challenge was performed two weeks after the first challenge. 06/20 and 5/20 animals showed positive reactions at 24-hour and 48-hour readings, respectively, when treated with 25 % test article dilution. No positive reactions were evident with ethanol alone. In the second challenge, 5/20 and 4/20 animals showed positive reactions at 24-hour and 48-hour readings respectively when treated with 25x test article dilutions. No positive reactions with ethanol alone. The positive skin reactions observed in the test group were below 30 % threshold required for the substance to be assessed skin sensitiser. Hence, based on the findings of this study, FAT 31064/F was considered to be not a skin sensitiser.

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

The substance was evaluated in two different studies namely maximisation test and modified Beuhler method for skin sensitisation potential.

Maximisation test

The skin sensitisation potential of FAT 31064/F has been investigated in a study conducted using Magnusson and Kligman maximation method as described in OECD Guideline 406. In this study, a group of guinea pigs containing 10 males and 10 females, received FAT 31064/F at 15% concentration in the intradermal induction phase and at 25 % concentration during the epidermal induction phase. The day before epidermal induction, the application sites were pretreated with 10 % sodium lauryl sulfate as open application. Two weeks after the epidermal induction application the animals were challenged with the occluded epidermal application for 24 hours on the flank with FAT 31064/F (concentration 25%) in ethanol and the vehicle alone. A rechallenge was done two weeks after the challenge. Six out of 20 and 5 out of 20 animals showed positive reactions at 24-hour and 48-hour readings respectively when treated with 25% test article dilution. No positive reactions were evident with ethanol alone. In the second challenge, Five out of 20 and 4 out of 20 animals showed positive reactions at 24-hour and 48-hour readings respectively when treated with 25X test article dilutions. No positive reactions with ethanol alone. The positive reactions observed in the test group either during the challenge or the rechallenge do not meet the 30% threshold required for the subtance to be assessed as a skin sensitiser. Hence the substance FAT 31064/F was considered to be not a skin sensitiser.

Modified Beuhler test

The purpose of this skin sensitizing study was to assess the possible allergenic potential of FAT 31'071/F when administered to the skin of albino guinea pigs.For this purpose the "Buehler-Test" modified by Ritz, H. L. and Buehler, E. V. (1980) was used. Ten females remained untreated and were used as control animals to be treated at challenge. Twenty test females were induced three times during induction and challenged with the test substance.In this study 0% of the animals of the test group were observed with significant reactions (grade of 0 and + are considered to be representative of insignificant responses, whereas those of 1 or greater are considered to be significant) when treated with the undiluted test article.The response of at least 15% positive animals is considered positive "R43" may cause sensitizer by skin contact following the commission 93/21/EEC, Commission Directive of April 27, 1993 adapting to technical progress for the 18th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Therefore, this test substance is considered to be a non-sensitizer when tested under the described conditions.

A substance is considered to be a skin sensitiser when 30% of the exposed animals show allergic reactions in the adjuvant test. In the maximisation test, only at 24 hour reading the substance had 30% animals showing positive reactions, while at 48 hours 25% of the exposed animals showed positive reactions. After the rechallenge, 25% and 20% exposed animals had positive reactions at 24 and 48 h readings. Only at the initial reading after challenge, 30% animals showed positive reactions. Hence, the substance can be considered to be a non-sensitiser. This finding was further supported by negative results in the modified Beuhler test.

Hence taking into account all the available information, the substance is considered to be a non-snesitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data, the substance does not warrant the classification for skin sensitisation as per CLP criteria (Regulation EC No. 1272/2008) criteria.