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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 266-257-8 | CAS number: 66215-27-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000/09/05 to 2000/11/30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 1998
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed prior to adoption of the LLNA (OECD 429).
Test material
- Reference substance name:
- N-cyclopropyl-1,3,5-triazine-2,4,6-triamine
- EC Number:
- 266-257-8
- EC Name:
- N-cyclopropyl-1,3,5-triazine-2,4,6-triamine
- Cas Number:
- 66215-27-8
- Molecular formula:
- C6H10N6
- IUPAC Name:
- N2-cyclopropyl-1,3,5-triazine-2,4,6-triamine
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Himalayan spotted
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4-6 weeks
- Weight at study initiation: Males: 332-417 g/ Females: 300-413 g
- Diet: Pelleted standard guinea pig breeding / maintenance diet, containing Vitamin C ad libitum.
- Water: Community tap water ad libitum
- Acclimation period: One week for the control and test group animals. The animals of the pretest were not acclimatized.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-21.5°C
- Humidity (%): 42-77%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): Automatically controlled light cycle of 12 hours light and 12 hours dark.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.5% CMC and 0.1% Tween 80 in bi-distilled water
- Concentration / amount:
- test group: 0.3 g of a 75% preparation of the test substance in vehicle
control group: 0.3 mL vehicle - Day(s)/duration:
- 48 hours
- Adequacy of induction:
- other: The concentrations of the test substance to be used in the test were determined in preliminary tests.
- Route:
- intradermal
- Vehicle:
- other: 0.5% CMC and 0.1% Tween 80 in bi-distilled water
- Concentration / amount:
- Three pairs of intradermal injections (0.1 ml/site) were made:
1) 1:1 (v/v) preparation of saline: Freud's complete adjuvant (FCA) - both groups
2) 5% w/v preparation of test substance in the vehicle - test group
vehicle - control group
3) 5% w/v preparation of test substance in a 1:1 mixture of saline and FCA - test group
1:1 (w/w) mixture of vehicle with the 1:1 mixture of saline and FCA - control group - Adequacy of induction:
- other: The concentrations of the test substance to be used in the test were determined in preliminary tests.
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.5% CMC and 0.1% Tween 80 in bi-distilled water
- Concentration / amount:
- 50% preparation of the test substance in vehicle
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- other: The concentrations of the test substance to be used in the test were determined in preliminary tests.
- No. of animals per dose:
- - test group: 10 animals/sex
- control group: 5 animals/sex - Details on study design:
- A. Induction - Intradermal injections
- No. of injections: Three pairs of intradermal injections
- Site: An area of dorsal skin from the scapular region(approx. 6x8cm)
B. Induction - Topical application
- No. of exposures: 1
- Exposure period: 48 hours
- Site: The scapular area
- Evaluation (hr after challenge): The skin of each animal was observed and scored for irritation at 24 and 48 hours after removal of the patches.
C. Challenge
- No. of exposures: 1
- Exposure period: 24 hours
- Site: The scapular area
- Evaluation (hr after challenge): The skin of each animal was observed and scored for irritation at approx. 24 and 48 hours after each challenge application.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- n.a.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- n.a.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
No animal died during the study. No signs of systemic toxicity were noted during the study. Body weight gain of the test animals was comparable to controls.
Following intradermal injections using FCA erythema, oedema, nectotizing, dermatitis, encrustation and exfoliation of encrustation were noted in both test and control animals. All these findings are considered common for FCA treated skin.
Results are provided below, in the overall remarks section.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a Maximization study, performed according to OECD/EC guidelines, Cyromazine showed no sensitization potential when applied to guinea pigs as a 50% preparation.
- Executive summary:
The skin sensitization potential of cyromazine, was tested on Himalayan spotted (GOHI) guinea pigs. No animal died during the study nor signs of systematic toxicity were observed. Following intradermal injections using FCA, erythema, oedema, nectotizing, dermatitis, encrustation and exfoliation of encrustation were noted in both test and control animals. All these findings are considered common for FCA treated skin. No skin reactions were noted following either induction topical or challenge applications. In summary, Cyromazine induced no sensitization when applied to guinea pigs as a 50% preparation in 0.5% CMC and 0.1% Tween 80 in bi-distilled water under the conditions of this study (Maximization Test).
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.
