Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

FAT 21030/D 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:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
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:
Test article : FAT 21030/D
Batch No : 16.36
Additional specification: Irganol Gruen BLS roh trocken
Contents/Purity: 67%
Physical properties: solid
Storage conditions: room temperature
Validity: December, 1998
Test article received: October 21, 1993
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Animal strain: Pirbright White Strain (Tif: DHP)
- Breeder: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Weight at study initiation: Between 326 to 400 g
- Housing: The animals were housed individually in Macrolon cages (Type 3), assigned to the different groups by means of random numbers generated by the random number generator, identified by individual ear tags.
- Diet: standard guinea pig pellets - NAFAG No. 845, Gossau SG, Ad-libitum
- Water: Ad libitum
- Acclimation period: 23 February, 1994 (5 days before the starting date of the experiment)

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3 °C
- Humidity: 30 to 70 %
- Photoperiod: 12 hours light cycle day.
Route:
intradermal
Vehicle:
other: physiological saline and adjuvant/saline mixture
Concentration / amount:
5 %
Day(s)/duration:
0
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
50 %
Day(s)/duration:
8
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
10 %
Day(s)/duration:
21
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
According to the test guidelines cited under "Introduction" the test was started with the minimum number of animals (5 per sex for the test group and 5 of one sex for controls). After the challenge procedure, it was not possible to conclude if the test substance is a sensitiser or not and therefore testing in additional animals was performed to give a total of 20 test and 10 control animals.
Details on study design:
Test procedure and concentrations used:
*Pretests (Intradermal Induction)
The concentration for the intradermal injections was selected on account of the solubility of the test article in standard vehicles and its local and systemic tolerability in a pretest. The following concentration of test article has been used for intradermal injection:
5 % in physiological saline (w/v).
Since 5 % FAT 21030/D in physiological saline could be injected and was well tolerated, this concentration was used for the intradermal induction.

*Pretest (Epidermal Applications (induction and challenge):
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations of FAT 21030/D have been examined on separate animals for the determination of the maximum subirritant concentration:
- 10, 20, 30, and 50 % in physiological saline.
- 50 % was the highest possible concentration of the test article in physiological saline.
Reactions were observed with 20, 30, and 50 % FAT 21030/D in physiological saline.

*Test procedure (Induction, intraderma injection):
- DAY 0: Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the left and right side of the shaved neck of the test and control group animals.

Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5% FAT 21030/D in physiological saline (w/v)
- 5% FAT 21030/D in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- physiological saline

DAY 8: INDUCTION, epidermal application
In the test group FAT 21030/D was incorporated in physiological saline and applied on a filterpaper patch to the neck of the animals; (occluded
administration for 48 hours). The control group was treated with the vehicle only.
Test group:
- 50% FAT 21030/D in physiological saline
Control group:
- physiological saline only

DAY 21: Challenge
The test and control group animals were tested on one flank with FAT 21030/D in physiological saline and on the other flank with the vehicle alone (occluded administration for 24 hours).

Test and control group:
- 10% FAT 21030/D in physiological saline
- physiological saline only

Adjuvant: Bacto adjuvant, Complete, Freund (Difco Lab. Detroit, Michigan USA)
Physiological saline (0.9%), sterile solution (Hausmann, St Gallen, Switzerland)
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole puriss. (Intradermal induction: 5 %, epidermal induction: 50 % and Epidermal challenge: 30 %)
Positive control results:
100 % animals showed positive reaction.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of toxicity
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of toxicity
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 % Challenge (Intradermal - 5 %, Epidermal - 50 %)
No. with + reactions:
1
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 % Challenge (Intradermal - 5 %, Epidermal - 50 %)
No. with + reactions:
1
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
30 % Challenge. (Induction - 5 % and Epidermal - 50 %)
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
30 % Challenge. (Induction - 5 % and Epidermal - 50 %)
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation

Observations:

Body weight were not affected by treatment.

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 21030/D is not a skin sensitiser.
Executive summary:

FAT 21030/D was tested for skin sensitisation potential in albino guinea pigs using the maximisation test. This test was performed according to the OECD Guideline No 406 (GLP). Based on the findings of the pre-study, the 5, 50 and 10 % test concentrations were used for intradermal induction (day 0), epidermal induction (day 8) and epidermal challenge (day 21), respectively. 1/20 animals showed a positive reaction in the treated group, while no positive reactions were found in the control group. Hence, under experimental conditions employed, 5 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressing. Hence, FAT 21030/D can be considered to be not a skin sensitiser.

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

FAT 21030/D was tested for skin sensitisation potential in albino guinea pigs using the maximisation test. This test was performed according to the OECD Guideline 406. Based on the findings of the pre-study, the 5, 50 and 10 % test concentrations were used for intradermal induction (day 0), epidermal induction (day 8) and epidermal challenge (day 21), respectively. 1/20 animals showed a positive reaction in the treated group, while no positive reactions were found in the control group. Hence, under experimental conditions employed, 5 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressing. Hence, FAT 21030/D can be considered to be not a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

FAT 21030/D is found to lack skin sensitisation potential in a GPMT study, hence it does not require classfication according to the criteria of Regulation (EC) No. 1272/2008.