Registration Dossier
Registration Dossier
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EC number: 427-720-1 | CAS number: 26364-65-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according OECD guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 427-720-1
- EC Name:
- -
- Cas Number:
- 26364-65-8
- Molecular formula:
- C4H5N3S
- IUPAC Name:
- [(1,3-thiazolidin-2-ylidene)amino]formonitrile
- Details on test material:
- name: Cyanamide, (4,5-dihydroxy-2-thiazolyl)-
molecular formula: C4 H5 N3 S
molecular weight: 127.2
physical state: solid
analytical purity: 98 %
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd Poc:DH
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH Laboratory Animal Breeders in 33176 Borchen
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 317 - 338 grams
- Housing: type IV Makrolon® cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least seven days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 40 - 60 %
- Air changes (per hr): >= 10 times per hour
- Photoperiod (hrs dark / hrs light): Twelve hours; artificial lighting from 6 AM to 6 PM
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction: 5% (= 20 mg test substance/animal)
Topical induction: 50% (= 250 mg test substance /animal)
Challenge: 50% (= 250 mg test substance/animal)
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction: 5% (= 20 mg test substance/animal)
Topical induction: 50% (= 250 mg test substance /animal)
Challenge: 50% (= 250 mg test substance/animal)
- No. of animals per dose:
- test substance group consisting of 10 experimental animals
one control group made up of 5 animals
and one range-finding group of 2 animals - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based on the findings of this study the substance is not subject to classification.
- Executive summary:
The Guinea Pig Maximization Test (GPMT) was performed on female guinea pigs to
determine whether the test substance 2-Cyanimino-1,3-thiazolidin exhibits skinsensitizing
properties.
The study was conducted with the following test substance concentrations:
Intradermal induction: 5%
Topical induction: 50%
Challenge: 50%
For the induction and the challenge treatment the test substance was formulated in
polyethylene glycol 400 to yield a solution (<= 10%) or a suspension (> 10%).
The challenge using a 50% test substance formulation led to no skin effects in the
animals in the control group and in the treatment group.
In summary, under the conditions of the maximization test and with respect to the
evaluation criteria the test substance therefore thus exhibits no skin-sensitization
potential.
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