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Diss Factsheets

Administrative data

Description of key information

A guinea pig maximisation test was performed to determine the sensitization potential of FAT 20202/E according to OECD Guideline 406 and EU Method B.6 (Skin Sensitisation). Ten females were used as control group and 20 females were used as test group. FAT 20202/E was used at 5 % for intradermal induction, while it was used at 10 % for epidermal induction. The highest non-irritating test article concentration used for both challenge applications was 1 %. In addition, the test article at 0.5 % was applied. No positive reactions were observed in the animals during the challenge phase. Only 1 animal out of 19 had positive reaction during the rechallenge at 1 % at the 24 hour reading, which was found to have reversed by 48-hour reading. No positive reaction was seen at 0.5 % during the rechallenge. Based on the findings of the study, FAT 20202/E is therefore classified as a non- sensitiser in albino guinea pigs.

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:
04 October, 1993 to 28 February, 1994.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
A second epidermal pretest was performed due to equivocal findings observed after the first epidermal pretest. The animals were weighed at their delivery
and at the end of the study. The allocation, age, number of animals were adapted to the additional animals.
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
Two test article concentrations were applied in the first and second challenge.
Principles of method if other than guideline:
None
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:
Identification: FAT 20202/E
Description: light red, solid
Batch Number: Op. 161
Purity/formation: 70.1 % active ingredients
Stability of test article: stable;expiration date: March, 1998
Stability of test article dilution: unknown in water, in vaselinum album and FCA:physiological saline (1:1); excluded from the Statement of Compliance
Storage Conditions: at room temperature (approx. 20 °C), away from direct sunlight
Safety precautions: Gloves, goggles and face mask were obligatory 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:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, CH-4414 Füllinsdorf/Switzerland
- Females (if applicable) nulliparous and non-pregnant: 30 females / 10 females, nulliparous and nonpregnant
- Housing: Individually in Makrol on type-3 cages (size: 22x37x15 cm) with standard softwood bedding
- Age at study initiation: 6 - 8 weeks except for the animals of the epidermal pretest II: 5-6 weeks
- Weight at study initiation: - at acclimatization start Control and Test Group 294 - 386 g
Intradermal pretest and epidermal pretest I 307 - 380 g
- at test day 3 Delivery of the epidermal pretest II: 274 - 338 g
- Diet: Pelleted standard Kliba 342, Batch nos. 79/93 (from acclimatization start to October 29, 1993) and 80/93 (from October 30, 1993 to November 12, 1993) 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: One week for the control and test group under test conditions after health examination. No acclimatization period for the animals of the pretest. Only animals without any visual signs of illness were used for the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 40-70 %,
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 lux) /12 hours dark, music during the light period.

IN LIFE PHASE: Start date: 4th October 1993: End date: 12th November 1993
Route:
intradermal
Vehicle:
other: bidistilled water
Concentration / amount:
5 %
Day(s)/duration:
Test Day 01
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, occlusive
Vehicle:
other: vaselinum album
Concentration / amount:
10 % in vaselinum album
Day(s)/duration:
Test Day 08
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: vaselinum album
Concentration / amount:
1% in vaselinum album (left cranial flank), a lower concentration of 0.5% in vaselinum album (left caudal flank) and vaselinum album only (right flank) using the same method as for the epidermal application.
Day(s)/duration:
Test Day 22
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
other: vaselinum album
Concentration / amount:
1% in vaselinum album (left cranial flank), a lower concentration of 0.5% in vaselinum album (left caudal flank) and vaselinum album only (right flank) using the same method as for the epidermal application.
Day(s)/duration:
Test Day 29
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
1. Control Group 10
2. Test Group 20
3. Intradermal Pretest 02
4. Epidermal Pretest I 04
5. Epidermal Pretest II 04
Details on study design:
RANGE FINDING TESTS:
PRETEST / performed during the acclimatization period. 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 APPLICATION I:
Both flanks of each of 4 guinea pigs were clipped and shaved just prior to the application. Thereafter patches of filter paper ( 2 x 2 cm) were saturated with
concentrations of 25 %, 15 %, 10 % and 5 % 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. 21 hours after removing of the dressing the application site was depilated with an approved depilatory cream (VEET Cream, Reckitt & Colmann AG, CH-4005 Basel) 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 dressings were removed after an exposure period of 24 hours. The reaction sites were assessed 24 (i.e. 3 hours after depilation) and 48 hours after removal of the bandage for erythema and oedema on a numerical basis according to Draize described above.

EPIDERMAL APPLICATION II:
A second epidermal pretest was performed because the highest non-irritating concentration could not be determined after the first epidermal pretest. The same way as described previously was performed. Only the test article concentrations were changed and the test article at 5, 1, 0.5 and 0.1% in vaselinum album was applied with four other guinea pigs. For the epidermal induction a 10% and for the challenge procedure a 1 % and 0.5 % test article solution was applied.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: not applicable
- Test groups: 1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) The test article, diluted to 5 % with bi-distilled water
3) The test article diluted to 5 % by emulsion in a 1:1 (v/v) mixture of Freund's complete adjuvant and physiological saline.
- Control group: 1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) Bi-distilled water
3) 1:1 (w/w) mixture of bi-distilled water in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline
- Site: area of dorsal skin from the scapular region
- Frequency of applications: Once
- Concentrations: 0.1 ml/site

B. INDUCTION EXPOSURE (epidermal)
- No. of exposure: 1
- Exposure period: 4 hours
- Site: scapular area (approximately 6 x 8 cm)
- Frequency of applications: Once
- Concentration: 10 % in vaselinum album

C. CHALLENGE EXPOSURE 01
- No. of exposures: 01
- Day(s) of challenge: Tets day 22
- Test groups: 1 % in vaselinum album (left cranial flank), a lower concentration of 0.5 % in vaselinum album (left caudal flank) and vaselinum album only (right flank)
- Site: left cranial flank and left caudal flank
- Concentrations: 1 and 0.5 %
- Evaluation (hr after challenge): 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.

D. CHALLENGE EXPOSURE 02
- No. of exposures: 01
- Day(s) of challenge: Tets day 29
- Test groups: 1% in vaselinum album (left cranial flank), a lower concentration of 0.5 % in vaselinum album (left caudal flank) and vaselinum album only (right flank)
- Site: left cranial flank and left caudal flank
- Concentrations: 1 and 0.5 %
- Evaluation (hr after challenge): 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.
Challenge controls:
None
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazol
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1 % in vaselinum album (left cranial flank), 0.5% in vaselinum album (left cuadal flank) and Vaselinum album (right flank)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: first challenge
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1 % in vaselinum album (left cranial flank), 0.5% in vaselinum album (left cuadal flank) and Vaselinum album (right flank)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: first challenge
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1% in vaselinum album (left cranial flank) and Vaselinum album (right flank) using the same method as for the epidermal application.
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: first challenge
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1% in vaselinum album (left cranial flank) and Vaselinum album (right flank) using the same method as for the epidermal application.
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: first challenge
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5% in vaselinum album (left cuadal flank) and Vaselinum album (right flank) using the same method as for the epidermal application.
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: first challenge
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5% in vaselinum album (left cuadal flank) and Vaselinum album (right flank) using the same method as for the epidermal application.
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: first challenge
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
Vaselinum album (left flank)
No. with + reactions:
0
Total no. in group:
10
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
Vaselinum album (left flank)
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
1% in vaselinum album (right cranial flank), Vaselinum album (left flank) using the same method as for the epidermal application.
No. with + reactions:
1
Total no. in group:
19
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
1% in vaselinum album (right cranial flank), Vaselinum album (left flank) using the same method as for the epidermal application.
No. with + reactions:
0
Total no. in group:
18
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5% in vaselinum album (right caudal flank), Vaselinum album (left flank) using the same method as for the epidermal application.
No. with + reactions:
0
Total no. in group:
19
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5% in vaselinum album (right caudal flank), Vaselinum album (left flank) using the same method as for the epidermal application.
No. with + reactions:
0
Total no. in group:
18
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
The intradermal induction was performed with a dilution at 5% in acetone. For the induction period and challenge procedure a 25% dilution of 2-MERCAPTOBENZOTHIAZOL in acetone was used.
No. with + reactions:
5
Total no. in group:
10

None

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20202/E is not a sensitiser.
Executive summary:

A guinea pig maximisation test was performed to determine the sensitization potential of FAT 20202/E according to OECD Guideline 406 and EU Method B.6 (Skin Sensitisation). Ten females were used as control group and 20 females were used as test group. FAT 20202/E was used at 5 % for intradermal induction, while it was used at 10 % for epidermal induction. The highest non-irritating test article concentration used for both challenge applications was 1%. In addition the test article at 0.5 % was applied. No positive reactions were observed in the animals during the challenge phase. Only 1 animal out of 19 had positive reaction during the rechallenge at 1 % at the 24 hour reading, which was found to have reversed by 48 hour reading. No positive reaction was seen at 0.5 % during the rechallnge. Based on the findings of the study, FAT 20202/E is therefore, classified as a non-sensitiser in albino guinea pigs.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data from the GPMT study, Acid Red 407 does not warrant classification for skin sensitisation under the CLP (1272/2008) Regulation.