Registration Dossier
Registration Dossier
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EC number: 201-369-2 | CAS number: 81-68-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 18 October, 1993 to 11 November, 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- 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 (non-LLNA method) conducted before the enforcement of Commission Commission Regulation (EU) 2017/706 of 19 April 2017 amending Annex VII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards skin sensitisation are available.
Test material
- Reference substance name:
- N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide
- EC Number:
- 201-369-2
- EC Name:
- N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide
- Cas Number:
- 81-68-5
- Molecular formula:
- C22H18N2O5S
- IUPAC Name:
- N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
- Specific details on test material used for the study:
- Test material: FAT 36034/E
Batch No.: 9300102
Expiry date: July, 1998
Purity: 93 %
Solubility: in water <0.1 g/L
Colour: red
Storage: at room temperature
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: 303 to 413 g
- Housing: The animals were housed individually in Macrolon cages (Type 3)
- Diet (e.g. ad libitum): Standard guinea pig pellets - NAFAG No. 845, Gossau SG (ad libitum)
- Water (e.g. ad libitum): Fresh water (ad libitum)
- Date of Acclimation: October 13, 1993
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30-70 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: To: October 18, 1993 to November 11, 1993
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: other: oleum arachidis and FCA/physiological saline (1/1) were used for the intradermal applications and vaseline for the epidermal applications
- Concentration / amount:
- 5 %
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 50 %
- Day(s)/duration:
- Day 8
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 50 %
- Day(s)/duration:
- Day 21
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Pretest:
Epicutaneous applications group: 2 animals (1 male and 1 female)
Main study:
Control group: 10 animals (5 male and 5 female)
Test group: 20 treated animals (10 male and 10 female) - Details on study design:
- Pretests
Intradermal Induction:
The concentration for the intradermal injections was selected on account of the solubility of the test substance in standard vehicles and its local and systemic tolerability in a pretest. The following concentration of test substance has been used for intradermal injection:
5 % in Oleum arachidis (w/v). Since 5 % test substance in Oleum arachidis 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 substance. The following concentrations of test substance have been examined on separate animals for the determination of the maximum subirritant concentration:
30 and 50 % in vaseline. 50 % in vaseline was the highest applicable concentration of the test substance. The tested concentrations did not induce erythema reactions.
Test procedure
DAY 0: INDUCTION, 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 % test substance in Oleum arachidis (w/v)
- 5 % test substance in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- Oleum arachidis
DAY 8: INDUCTION, epidermal application:
The application site of all animals was pretreated with 10 % sodium-laurylsulfate (open application) 24 h prior to the epidermal induction application.
In the test group test substance was incorporated in Vaseline (w/w) 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 h). The control group was treated with the vehicle only.
Test group:
- 50 % test substance in vaseline
Control group:
-Vaseline only
DAY 21: Challenge
The test and control group animals were tested on one flank with test substance in vaseline (w/w) and on the other flank with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 24 h).
Test and control group:
- 50 % test substance in vaseline
- vaseline only - Challenge controls:
- The control group animals were tested on one flank with test substance in vaseline (w/w) and on the other flank with the vehicle alone:
Control group:
- 50 % test substance in vaseline
- vaseline only - Positive control substance(s):
- yes
- Remarks:
- (2-mercaptobenzothiazole tested in another study)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Intradermal: 5 %, epidermal: 50 %, challenge: 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Intradermal: 5 %, epidermal: 50 %, challenge: 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no 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:
- Intradermal: 5 %, epidermal: 50 %, challenge: 30 %
- No. with + reactions:
- 9
- 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:
- Intradermal: 5%, epidermal: 50%, challenge: 30%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
None of the animals of the test group showed skin reactions 24 and 48 h after removing the dressings.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance did not induce delayed contact hypersensitivity in treated animals.
- Executive summary:
A guinea pig maximization study was conducted to evaluate the skin sensitization potential of the test substance (of ca. 93 % purity) according to OECD Guideline 406 and EU Method B.6 in compliance with GLP. Based on the results of a preliminary study, 5 and 50 % were selected as intradermal and topical induction doses. The highest non-irritating concentration used for challenge application was 50 %. None of the animals of the test group showed skin reactions at 24 and 48 h following challenge. Under the study conditions, the test substance did not induce delayed contact hypersensitivity in treated animals.
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