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Diss Factsheets

Administrative data

Description of key information

FAT 20010/C is regarded as non-sensitizer.

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:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
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:
Denomination: FAT 20010/C
Presentation: red powder
Purity: 78.83 %
Batch number: 149
Date of receipt: 9 March 1995
Storage: at room temperature
Expiry date: December 1999
pH= 9.1
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Age at study initiation: about 6 weeks old
- Weight at study initiation: 250 - 550 g.
- Housing: animals housed in groups according to EEC/86/609 in stainless steel mesh cages (internal dimensions 500 x 600 x 200 mm).
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days between animal arrival and start of treatment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 3°C (target values)
- Humidity (%): ≥45 % R.H. (target values),
- Air changes (per hr): ≥22 air changes per hour,
- Photoperiod (hrs dark / hrs light): 12 hours light (artificial)/12 hours dark.
Route:
intradermal
Vehicle:
other: Water for injection
Concentration / amount:
0.1%
Day(s)/duration:
1
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, occlusive
Vehicle:
other: paste in water
Concentration / amount:
56%
Day(s)/duration:
9
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: water for injection
Concentration / amount:
1%
Day(s)/duration:
22
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
30 animals of both sexes, allocated to one control group of 10 animals (induction: vehicle - challenge : test article) and one treated group of 20 animals (induction and challenge: test article).
Details on study design:
.During induction, the applications were performed as follows:
. Treated group:
-By intradermal route: 3 series of 2 x 0.1 ml injections
*Freund's complete adjuvant at 50 % (V/V) in an isotonic injectable solution
*test article in a 0.1 % (W/W) solution in water for injection;
*mixture 50/50 (V/V): test article in a 0.2 % (W/W) solution in water for injection + Freund's complete adjuvant at 50 % (V/V) in an isotonic injectable solution, i.e. a final 0.1 % concentration of the test article.
During the preliminary study, injection of the test article in a 0.1 % solution tinted the skin of the animals thus making observation of erythema impossible. No oedema was noted.
-By topical occlusive route for 48 hours, with 0.5 ml of the test article in a 56 % (W/W) paste in water for injection.
During the preliminary study, the test article tinted the skin of the animals thus making observation of erythema impossible. Nevertheless as no oedema was noted, a skin painting was performed during the main study on Day 8, with 0.5 ml of sodium lauryl sulphate at 10 % (W/W) in Codex paraffin to create irritation.

Control group:
The intradermal injections and the topical occlusive application for 48 hours were carried out under the same conditions as in the treated group, water for injection replacing the test article. The rest period was 11 days without treatment. During the challenge, the topical occlusive application for 24 hours was performed in the treated group and in the control group with the test article in a 1 % (WIW) solution in water for injection and at the dose level of 0.5 ml (Maximum Non-Irritant Concentration: M.N.I.C.). The cutaneous macroscopic examinations were performed 24 and 48 hours after removal of the patches to the challenge application site, according to the Magnusson & Kligman scale. As the test article tinted the skin of the animals, thus making observation of erythema impossible, histopathological examinations of the skin were performed for all the animals of the treated and control groups (in half of them at 24 hours and in the other half at 48 hours).
Challenge controls:
one control group of 10 animals (induction : vehicle - challenge : test article)
Positive control substance(s):
yes
Remarks:
1-CHLOR-2,4- DINITROBENZOL
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1% Intradermal Induction, 56% Epidermal Induction, 1% Challenge.
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1% Intradermal Induction, 56% Epidermal Induction, 1% Challenge.
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0.
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:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.05% Intradermal induction, 0.05% Challenge exposure
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Positive control group treated with DNCB are regularly carried out and 80 to 100% of sensitized animals are usually observed.

Determination of a weak to moderate irritant concentration by intradermal injection

Evaluation of the reactions at different observation times
    24 hours 48 hours
After the intradermal injections  
Sex/Guinea pig No Concentrations 1 % 0.10 % 0.05 % 1 % 0.10 % 0.05 %
M/61675 Erthema    (+Oedema) 3 ? ? ? ? ?
Other anomaly Y U U U U U
M/61676 Erthema    (+Oedema) ? ? ? ? ? ?
Other anomaly U U U U U U
F/61677 Erthema    (+Oedema) 3 ? ? ? ? ?
Other anomaly Y U U U U U
F/61678 Erthema    (+Oedema) ? ? ? ? ? ?
Other anomaly U U U U U U

? - Reading impossible

U - The test article tinted the skin of the animals thus making erythema observation impossible. No oedema was noted.

Y - The test article tinted the skin making erythema observation impossible. The maximum score (score = 3) was attributed because of the presence of oedema.

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance FAT 20010/C is regarded as non-sensitizer.
Executive summary:

A GLP compliant OECD guideline 406 test was performed on albino Hartley guinea-pigs to evaluate the delayed cutaneous hypersensitivity of the test article according to a maximized protocol using 30 animals of both sexes, allocated to one control group of 10 animals and one treated group of 20 animals. Animals were exposed to test article by 3 series of 2 X 0.1 ml injections. Test solution was made as 0.1 % (W/W) solution in water for injection. During the preliminary study, the test article tinted the skin of the animals thus making observations of erythema impossible. Nevertheless as no oedema was noted, a skin painting was performed during the main study on Day 8, with 0.5 ml of sodium lauryl sulphate at 10 % (W/W) in Codex paraffin to create irritation. After a rest period of 11 days, challenge study was performed with the topical occlusive application for 24 h in treated and control group with the test article in a 1 % (W/W) solution in water for injection and at the dose level of 0.5 ml (Maximum Non-irritant concentration). The cutaneous macroscopic examination were performed 24 and 48 h after removal f the patches to the challenge application site, according to the Magnusson & Kligman scale. As the test article tinted the skin of the animals, thus making observations of erythema impossible, histopathological examination of the skin were performed for all the animals of the treated and control groups. Signs of irritation were noted during induction after application of sodium lauryl sulphate in both groups. After challenge, the macroscopic and histopathological examinations did not reveal any lesion of delayed hypersensitivity in the 20 treated animals. No noticeable cutaneous abnormality was noted in the 10 guinea-pigs examined in the control group. From the results obtained under the experimental conditions employed, the test article did not provoke any reaction of cutaneous sensitization in the animals examined. Hence, the test substance FAT 20010/C is regarded as non-sensitizer.

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

A GLP-compliant OECD guideline 406 test was performed in the albino Hartley guinea-pig, to evaluate skin sensitisation of the test substance using the GPMT protocol according to Magusson and Kligman. In total 30 animals of both sexes were used, allocated to one control group of 10 animals (induction : vehicle - challenge : test article) and one treated group of 20 animals (induction and challenge : test article). Animals were exposed to test article by 3 series of 2 X 0.1 ml injections. Test solution was made as 0.1% (W/W) solution in water for injection. During the preliminary study, the test article tinted the skin of the animals thus making observations of erythema impossible. Nevertheless, as no oedema was noted, a skin painting was performed during the main study on Day 8, with 0.5 ml of sodium lauryl sulphate at 10 % (W/W) in Codex paraffin to create irritation. After a rest period of 11 days, a challenge was performed with the topical occlusive application for 24 h in treated and control group with the test article in a 1 % (W/W) solution in water for injection and at the dose level of 0.5 ml (Maximum Non-irritant concentration). The cutaneous macroscopic examination was performed 24 and 48 h after removal of the patches to the challenge application site, according to the Magnusson & Kligman scale. As the test article tinted the skin of the animals, thus making observations of erythema impossible, histopathological examination of the skin were performed for all the animals of the treated and control groups. Signs of irritation were noted during induction after application of sodium lauryl sulphate in both groups. After challenge, the macroscopic and histopathological examinations did not reveal any lesion of delayed hypersensitivity in the 20 treated animals. No relevant cutaneous abnormality was noted in the 10 guinea-pigs examined in the control group. From the results obtained under the experimental conditions employed, the test article did not provoke any reaction of cutaneous sensitization in the animals examined. Hence, the test substance FAT 20010/C is regarded as non-sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the finding of the skin sensitization study, the test substance does not need to be classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.