Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 271-351-7 | CAS number: 68541-71-9
Skin sensitisation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- 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.
Test material
- Reference substance name:
- Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)
- EC Number:
- 271-351-7
- EC Name:
- Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)
- Cas Number:
- 68541-71-9
- Molecular formula:
- C32H17CrN6O11S.2Na
- IUPAC Name:
- disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)
- Test material form:
- other: solid
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- Test article: FAT 20011/D
Batch No.: 61
Additional specification: Lanacron Marine S-G roh feucht
Contents/Purity: CA. 52.5 %
Physical properties: solid
Storage conditions: room temperature
Validity: July, 1999
Test article received: March 22, 1994
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA GEIGY Limited, Animal Production, 4332 Stein/ Switzerland
- Weight at study initiation: 334 to 405 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.
- The animals received ad libitum standard guinea pig pellets - NAFAG No. 845, Gossau SG and fresh water.
ENVIRONMENTAL CONDITIONS
- Temperature: 22+/-3 °C.
- Humidity: 30 to 70 %.
- Photoperiod: 12 hours light cycle day.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Remarks:
- and adjuvant/saline mixture (1:1)
- 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 technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 30 %
- Day(s)/duration:
- 21
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- According to the test guidelines 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:
- RANGE FINDING TESTS:
- Intradermal induction: 5 % in physiological saline (w/v). Since 5 % FAT 20011/D in Physiological saline could be injected and was well tolerated, this concentration was used for the intradermal induction.
- 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 20011/D have been examined on separate animals for the determination of the maximum sub-irritant concentration 20, 30 and 50% in physiological saline. The undiluted test article was not applicable to the skin. 50% was the highest possible concentration of the test article in physiological saline.
MAIN STUDY
A. INDUCTION EXPOSURE, intradermal injections.
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 20011/D in Physiological saline (w/v)
- 5 % FAT 20011/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 20011/D was incorporated in physiological saline and applied on a filterpaper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g per patch; occluded administration for 48 hours). The control group was treated with the vehicle only.
Test group:
- 50 % FAT 20011/D in physiological saline
Control group:
- physiological saline only
B. CHALLENGE EXPOSURE
The test and control group animals were tested on one flank with FAT 20011/D in physiological saline and on the other flank with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 24 hours).
Test and control group:
- 30 % FAT 20011/D in physiological saline
- physiological saline only - Challenge controls:
- Control group animals wese tested on one flank with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 24 hours).
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole
Results and discussion
- Positive control results:
- 20/20 animals showed positive reactions.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Intradermal induction: 5 %, epidermal induction: 50 %, challenge: 30 %
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Intradermal induction: 5 %, epidermal induction: 50 %, challenge: 30 %
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- chellenge: 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Challenge: 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 30%
- 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%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Maximisation grading (according to Magnusson and Kligman)
Sensitisation rate (%) |
Grade |
Classification |
0-8 |
I |
weak |
9-28 |
II |
mild |
29-64 |
II |
moderate |
65-80 |
IV |
strong |
81-100 |
V |
extreme |
Challenge reactions after epidermal application
(CONTROL GROUP)
DRAIZE Score 24 and 48 hours after removal of the dressing
Vehicle control
Male animals |
121 |
122 |
123 |
124 |
125 |
Erythema Score |
0 |
0 |
0 |
0 |
0 |
Edema Score |
0 |
0 |
0 |
0 |
0 |
Female animals |
11 |
12 |
13 |
14 |
15 |
Erythema Score |
0 |
0 |
0 |
0 |
0 |
Edema Score |
0 |
0 |
0 |
0 |
0 |
Test article control
Male animals |
121 |
122 |
123 |
124 |
125 |
Erythema Score |
0 |
0 |
0 |
0 |
0 |
Edema Score |
0 |
0 |
0 |
0 |
0 |
Female animals |
11 |
12 |
13 |
14 |
15 |
Erythema Score |
0 |
0 |
0 |
0 |
0 |
Edema Score |
0 |
0 |
0 |
0 |
0 |
Challenge reactions after epidermal application
(TEST GROUP)
DRAIZE Score 24 hours after removal of the dressing
Vehicle Control
Male animals |
06 |
07 |
08 |
09 |
10 |
126 |
127 |
128 |
129 |
130 |
Erythema Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Female animals |
16 |
17 |
18 |
19 |
20 |
136 |
137 |
138 |
139 |
140 |
Erythema Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Test Article:
Male animals |
06 |
07 |
08 |
09 |
10 |
126 |
127 |
128 |
129 |
130 |
Erythema Score |
1 |
1 |
0 |
0 |
2 |
1 |
0 |
1 |
1 |
1 |
Edema Score |
0 |
2 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
Female animals |
16 |
17 |
18 |
19 |
20 |
136 |
137 |
138 |
139 |
140 |
Erythema Score |
0 |
0 |
1 |
1 |
0 |
2 |
0 |
1 |
0 |
1 |
Edema Score |
0 |
0 |
1 |
1 |
0 |
2 |
0 |
0 |
0 |
0 |
DRAIZE Score 48 hours after removal of the dressing
Vehicle control
Male animals |
06 |
07 |
08 |
09 |
10 |
126 |
127 |
128 |
129 |
130 |
Erythema Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Female animals |
16 |
17 |
18 |
19 |
20 |
136 |
137 |
138 |
139 |
140 |
Erythema Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Test Article
Male animals |
06 |
07 |
08 |
09 |
10 |
126 |
127 |
128 |
129 |
130 |
Erythema Score |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
Edema Score |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
Female animals |
16 |
17 |
18 |
19 |
20 |
136 |
137 |
138 |
139 |
140 |
Erythema Score |
0 |
0 |
1 |
1 |
0 |
2 |
0 |
0 |
0 |
2 |
Edema Score |
0 |
0 |
1 |
1 |
0 |
2 |
0 |
0 |
0 |
1 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- FAT 20011/D can be considered to be a skin sensitiser.
- Executive summary:
A guinea pig maximization study was conducted to evaluate the skin sensitization potential of the FAT 20011/D according to OECD Guideline 406 and EU Method B.6 in compliance with GLP. Based on the results of a preliminary study, concentrations of 5 and 50 % of FAT 20011/D were selected for intradermal and topical induction concentrations, respectively, while the test concentration of 30 % was chosen for challenge. After challenge, 12/20 and 8/20 animals showed positive reactions after 24 and 48h respectively. Hence, it was concluded that, FAT 20011/D did show a skin-sensitising (contact allergenic) potential in albino guinea pigs.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
