Registration Dossier
Registration Dossier
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EC number: 274-700-1 | CAS number: 70616-89-6
Endpoint summary
Administrative data
Description of key information
The results of both Guinea Pig Maximisation Tests are different. The test carried out in 1994 is considered a key test as this assay follows accepted guideline and it is well documented. The earlier assay is not described in detail and it is not entirely clear whether the response is caused by skin irritation or sensitization.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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)
- Version / remarks:
- adopted 17.7.1992
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Information not available.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: Anlab, Prag, Czech Republic- Females (if applicable) nulliparous and non-pregnant: yes- Microbiological status of animals, when known: without parasites, microorganisms, viruses and fungi- Weight at study initiation: 300 - 366 g- Housing: T4 cages (5 animals per cage)- Diet (e.g. ad libitum): granulated commercially produced feed mixture- Water (e.g. ad libitum): drinking water with addition of ascorbic acid (20 mg/animal/day)- Acclimation period: 1 week
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 1 % w/w Reactive Orange 13
- Day(s)/duration:
- day 0
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- other: Freund's Complete Adjuvant
- Concentration / amount:
- 1 % w/w Reactive Orange 13
- Day(s)/duration:
- day 0
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 25 % w/w Reactive Orange 13
- Day(s)/duration:
- day 7
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 1 % w/w Reactive Orange 13
- Day(s)/duration:
- day 20
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 1 % w/w Reactive Orange 13
- Day(s)/duration:
- day 27
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Treated group: 20 animalsControl group: 10 animals
- Details on study design:
- MAIN STUDY A. INDUCTION EXPOSURE - No. of exposures: 2 (intradermal and epicutaneous) - Test groups: 1 (20 animals) - Control group: 1 (10 animals) - Site: nape - Concentrations: 1 % (intradermal exp.), 25 % (epicutaneous exp.) B. CHALLENGE EXPOSURE - No. of exposures: 2 - Day(s) of challenge: day 20 and 27 - Test groups: 1 (20 animals) - Control group: 1 (10 animals) - Site: nape - Concentrations: 1 % - Evaluation (hr after challenge): 1, 24, 48 and 72 hours after application
- Positive control substance(s):
- no
- Key result
- Hours after challenge:
- 1
- Group:
- test chemical
- Dose level:
- 1 % w/w Reactive Orange 13
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin or any clinical reaction
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 % w/w Reactive Orange 13
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin or any clinical reaction
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 % w/w Reactive Orange 13
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin or any clinical reaction
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1 % w/w Reactive Orange 13
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin or any clinical reaction
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to results of Guinea Pig Maximisation Test, the test substance, Reactive Orange 13, need not be classified as skin sensitiser, pursuant to Regulation (EC) No. 1272/2008.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- None
- Specific details on test material used for the study:
- None
- 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, CH-4414 Füllinsdorf- Age at study initiation: males 7 weeks females: 8 weeks- Weight at study initiation: males: 337 - 446 g females: 306 - 446 g- Housing: Individually in Makrolon type-3 cages with standard softwood bedding- Diet (e.g. ad libitum): Diet Pelleted standard Kliba 342, Batch 57/90 guinea pig breeding/ maintenance diet ("Kliba", Klingentalmühle AG, CH-4303 Kaiseraugst), ad libitum.- Water (e.g. ad libitum): Community tap water from Itingen, ad libitum. Once weekly additional supply of ascorbic acid via the drinking water.- Acclimation period: One week under test conditions after veterinary examination.ENVIRONMENTAL CONDITIONS- Temperature (°C): 22 + 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/12 hours dark
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- Test group:1) Freund's complete adjuvant 50:50 with bi-d1stilled water.2) The test article, diluted to 5% with physiological saline.3) The test article at the concentration used in (2), emulsified in a 50:50mixture of Freund's complete adjuvant and the vehicle used in (2).Control Group:1) Freund's complete adjuvant 50:50 with bi-distilled water.2) Vehicle used in (2) for test group.3) Freund's complete adjuvant 50:50 with b1-disti1 led water.
- Day(s)/duration:
- Test Day 01
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- epicutaneous, open
- Vehicle:
- petrolatum
- Concentration / amount:
- 25 % in petrolatum-oilApproximately 24 hours prior to the epidermal application the test area waspretreated with 10 % Sodium-Lauryl-Sulfat (SLS) in petrolatum-oil
- Day(s)/duration:
- Test Day 07
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- petrolatum
- Concentration / amount:
- 25 % in petrolatum-oil
- Day(s)/duration:
- Test Day 22
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 animals per dose
- Details on study design:
- None
- Challenge controls:
- None
- Positive control substance(s):
- yes
- Remarks:
- HCHO
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40170013 is not a sensitiser.
- Executive summary:
A guinea pig maximisation test was performed to determine the sensitization potential of FAT 40170 according to the OECD Guideline 406 and EU Method B.6 (Skin Sensitisation).
No positive reactions were observed in the animals when treated with the test substance dissolved in 25 % petrolatum. FAT 40170 is therefore, classified as a non-sensitiser in albino guinea pigs according to the grading of Magnusson and Kligman.
Referenceopen allclose all
None
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 available GPMT tests results, the test substance does not cause skin sensitisation. No respiratory sensitisation data is available. Reactive Orange 13 does not meet the criteria for classification according to Regulation (EC) No. 1272/2008.
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