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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 213-697-3 | CAS number: 1003-03-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP study. NO OECD and EU guidelines were followed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- Method: according to Magnusson B. und Kligman A.M.: J. Invest. Derm. 52, 268-276
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Cyclopentylamine
- EC Number:
- 213-697-3
- EC Name:
- Cyclopentylamine
- Cas Number:
- 1003-03-8
- Molecular formula:
- C5H11N
- IUPAC Name:
- cyclopentanamine
- Test material form:
- other: liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Darley Oaks, Newchurch, Burton upon Trent, Staffordshire
- Weight at study initiation: 300 - 450 g
- Housing: Animals were housed in groups of five in suspended metal cages.
- Diet: ad libitum, Guinea Pig Diet, J . Waring (Feeds) Limited, Shardlow, Derbyshire
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 + 3°C
- Photoperiod (hrs dark / hrs light): 14 hours light, 10 hours dark
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- - Intradermal induction: 1% in water
- Topical induction: 10% in water
- Topical challenge: 2% in water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- - Intradermal induction: 1% in water
- Topical induction: 10% in water
- Topical challenge: 2% in water
- No. of animals per dose:
- 10 (4 animals control group)
- Details on study design:
- RANGE FINDING TESTS:
a) intradermal injection: An area measuring 4 x 6 cm in the shoulder region of 2 guinea pigs was clipped free of hair using oster A5 electric animal clippers. Into these areas were injected simultaneously six 0 .1 mL intradermal injections as follows : 5% (animal 1) and 1% (animal 2). Animals were observed 24, 48 and 72 hours and 7 days following treatment and any evidence of localized necrosis or systemic toxicity was recorded. Using information obtained from this preliminary test the concentration of test material to be used for the Main Study was selected .
b) The test material at four concentrations (usually 100%, 50%, 25% and 10%) was topically applied under an occlusive patch to four sites on the shaved backs of each of a group of two guinea pigs. The degree of irritancy at the test sites were evaluated for erythema immediately after removal of the patches and then at 24 and 48 hours . The concentrations of the test material to be used on two further animals were chosen, applied and then evaluated after similar time intervats. Using the information obtained from this preliminary test the concentrations to be used for topical challenge in the Main Study were selected.
MAIN STUDY
A. INDUCTION EXPOSURE (indradermal)
- No. of exposures: 1
- Exposure period: single exposure
- Test groups: The treated animals were injected on three different sites of the shaved flank with either of three solutions (Freuds complete adjuvance (FCA) alone, test material alone, test material with FCA).
- Control group:The control animals were received similar treatment to the test group (FCA alone, sodium chloride alone, sodium chloride with FCA)
- Site: shoulder region
- Frequency of applications: single
If the test material was found to be non-irritating in the siting test, the area was pretreated with 10% sodium lauryl sulphate (SLS) in petrolatum 24 hours prior to topical application.
INDUCTION EXPOSURE (topical application)
- No. of exposures: 1
- Exposure period: at day 7
- Test groups: The treated animals were induced with the test substance.
- Control group:The control animals were treated with sodium chloride.
- Site: shoulder region
- Frequency of applications: single
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after the topical induction
- Exposure period: 24, 48 h
- Test groups: The animals were treated with the test material.
- Control group: The control animals were treated with the vehicle (only).
- Site: shoulder region
- Concentrations: 2 %
- Evaluation (hr after challenge):24 and 48 hours - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 2 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 2 %. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2 %. No with. + reactions: 4.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2 %. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2 %
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2 %. No with. + reactions: 2.0. Total no. in groups: 10.0.
Any other information on results incl. tables
As indicated in the above table 4/10 of the animals in the test group showed evidence of erythema at the challenge sites. As no evidence of erythema was observed in any of the control animals, these effects seen in the test group were attributed to contact sensitization.
The test material, therefore, produced a 40% sensitization rate and was classified as a moderate (GRADE III) contact sensitizer.
Applicant's summary and conclusion
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.
