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Diss Factsheets

Administrative data

Description of key information

FAT 21021/D was found to be a skin 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:
Experiment start date - 06 March 1995; Experiment end date - 30 March 1995; Study completion date - 10 April 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
Qualifier:
according to guideline
Guideline:
EU Method B.6 (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:
Code number: FAT 21021/D
Batch-Nr.: 9
Purity: ca 70 %
Appearance: solid
Solubility: 30 g/l
Storage: room temperature
Expiration: 12/99
Species:
guinea pig
Strain:
Himalayan
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4, 4414 Füllinsdorf/Switzerland
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: Control and Test Group 349 - 441 g, Pretest 393 - 444 g
- Housing: Individually in Makrolon type-3 cages
- Diet: Pelleted standard Kliba 342, Batch nos. 67/94 (from 27-FEB-1995) and 68/95 (from 14-MAR-1995 until termination) guinea pig breeding/maintenance diet ("Kliba", Klingentalmühle AG, CH-4303 Kaiseraugst), ad libitum.
- Water: Community tap water from Füllinsdorf, ad libitum. Once weekly additional supply of ascorbic acid (1 g/1) via the drinking water.
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature: 20-21 °C
- Humidity: 50-64 %
- Photoperiod: 12 h light/12 h dark, (approx. 100 Lux)

IN-LIFE DATES: From March 06, 1995 to March 30, 1995
Route:
intradermal
Vehicle:
water
Remarks:
Bi-distilled
Concentration / amount:
5 %
Day(s)/duration:
Day 1
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
other: Vaselinum album
Concentration / amount:
75 %
Day(s)/duration:
Day 8
Adequacy of induction:
highest technically applicable concentration used
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: Vaselinum album
Concentration / amount:
25 %
Day(s)/duration:
Day 22
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Pretest: 6 animals
Main test: 10 Control and 20 Test group.
Details on study design:
RANGE FINDING TESTS: The objective of this investigation was to identify a maximally tolerated concentration of the test article 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.

The procedure employed for these investigations was as follows:
INTRADERMAL INJECTIONS: Intradermal injections (0.1 ml/site) were made into the clipped flank of two guinea-pigs at concentrations of 5, 3 and 1 % of the test article in bi-distilled water. The resulting dermal reactions were assessed 24 hours later. For intradermal induction application a 5% test article dilution was selected.

EPIDERMAL APPLICATIONS:
Both flanks of each of 4 guinea pigs were clipped and shaved just prior to the application. Thereafter 4 patches of filter paper (2 x 2 cm) were saturated with the test article at A = 75% (this concentration used was found to be the most qualified to assure an optimum technical application procedure), B =50 %, C = 25 % and D = 15 % of the test article in vaselinum album and applied to the clipped and shaved flanks. The patches were covered by a strip of aluminum foil and firmly secured by elastic plaster wrapped around the trunk and covered with impervious adhesive tape. This procedure ensured the intensive contact of the test article. The dressings were removed after an exposure period of 24 hours. 21 hours after removal of the dressing the application site was depilated with an approved depilatory cream (VEET Cream, Reckitt & Colman AG, CH-4123 Allschwil) to clean the application site from staining produced by the test article, so that possible erythema reactions were clearly visible at that time. The depilatory was placed on the patch sites and surrounding areas, and left on for 3-5 minutes. It was then thoroughly washed off with a stream of warm, running water. The animals were then dried with a disposable towel, and returned to their cages. The reaction sites were assessed 24 and 48 hours after removal of the bandage for erythema and oedema on a numerical basis according to Draize described below.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: One intradermal injection and one epidermal application.
- Test groups: 5 %
- Control group: Yes
- Frequency of applications: Once

B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: 22
- Test groups: 5 %
- Control group: Yes
- Evaluation (hrs after challenge): 24 and 48 hours.

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.
Positive control substance(s):
yes
Remarks:
2-MERCAPTOBENZOTHIAZOLE
Positive control results:
60 % of test animals showed positive response (6/10).
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Intraderma induction: 5 %; epidermal induction: 75 %; epidermal challenge: 25 %
No. with + reactions:
7
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Intraderma induction: 5 %; epidermal induction: 75 %; epidermal challenge: 25 %
No. with + reactions:
6
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:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Epidermal challenge - 25% in mineral oil
No. with + reactions:
6
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
Epidermal challenge - 25 % in mineral oil
No. with + reactions:
6
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
FAT 21021/D caused sensitisation to the skin under the condictions of this test.
Executive summary:

To assess the allergenic potential of FAT 21021/D in albino guinea pigs, the maximization-Test (B. Magnusson and A.M. Kligman (1969)) was followed in a GLP-compliant study. Ten females were used as control group and 20 females were used as test group.In addition to the sensitizing reactions the following observations and data were recorded during the test and observation period, they were Viability/Mortality, Clinical Signs, Skin reactions, Body Weights and Necropsy. As the test article stained the skin violet, it was not possible to determine whether erythema was present. However, no oedema was observed. No positive reactions were observed in the animals treated with vaselinum album alone. Seven and six out of 20 animals were observed with very slight to well defined erythematous reactions at the 24- and 48-hour reading respectively when treated with the test article at 25 % in vaselinum album. Violet discoloration was observed after removal of the dressing. As there were no deaths during the course of the treatment period no necropsies were performed. No symptoms of systemic toxicity were observed in the animals. Two out of 10 animals of the control group, two out of 20 animals of the test group and 3 out of 4 animals of the epidermal pretest lost weight during the acclimatization period. No loss of weight was observed during the treatment period. In this study 35 % and 30 % of the animals of the test group were observed with positive skin reactions after treatment with a non-irritant test substance concentration of 25 % in vaselinum album. No skin reactions were observed in the control group. The response of at least 30 % positive animals is considered positive following the "Commission Directive 93/21/EEC, 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, the test article POLAR ROT RLS ROH TROCKEN (FAT 21021/D) at concentration of 25 % in vaselinum album is considered to be a sensitizer when described under the test conditions. According to the rating of allergenicity by Magnusson and Kligman the test article is a moderate sensitizer.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

To assess the allergenic potential of FAT 21021/D in albino guinea pigs, the maximization-Test (B. Magnusson and A.M. Kligman (1969)) was followed in a GLP compliant study. Ten females were used as control group and 20 females were used as test group.In addition to the sensitizing reactions the following observations and data were recorded during the test and observation period, they were Viability/Mortality, Clinical Signs, Skin reactions, Body Weights and Necropsy. As the test article stained the skin violet, it was not possible to determine whether erythema was present. However, no oedema was observed. No positive reactions were observed in the animals treated with vaselinum album alone. Seven and six out of 20 animals were observed with very slight to well defined erythematous reactions at the 24- and 48-hour reading respectively when treated with the test article at 25 % in vaselinum album. Violet discoloration was observed after removal of the dressing. As there were no deaths during the course of the treatment period no necropsies were performed. No symptoms of systemic toxicity were observed in the animals. Two out of 10 animals of the control group, two out of 20 animals of the test group and 3 out of 4 animals of the epidermal pretest lost weight during the acclimatization period. No loss of weight was observed during the treatment period. In this study 35 % and 30 % of the animals of the test group were observed with positive skin reactions after treatment with a non-irritant test substance concentration of 25 % in vaselinum album. No skin reactions were observed in the control group. The response of at least 30 % positive animals is considered positive following the "Commission Directive 93/21/EEC, 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, the test article POLAR ROT RLS ROH TROCKEN (FAT 21'021/D) at concentration of 25 % in vaselinum album is considered to be a sensitizer when described under the test conditions. According to the rating of allergenicity by Magnusson and Kligman the test article is a moderate sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Acid Red 260 was found to have sensitising potential to the skin, hence it needs to be classified as skin sensitiser cat 1B according to the criteria set by Regulation (EC) No. 1272/2008.