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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-895-8 | CAS number: 111-68-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was performed before the implementation of the REACH regulation.
Test material
- Reference substance name:
- Heptylamine
- EC Number:
- 203-895-8
- EC Name:
- Heptylamine
- Cas Number:
- 111-68-2
- Molecular formula:
- C7H17N
- IUPAC Name:
- heptan-1-amine
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): MONO-n-HEPTYLAMINE (C7A)
- Physical state: colorless liquid
- Analytical purity: 99.51%
- Lot/batch No.: LABORATOIRE L 8602
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Shamrock Bioservices - 12, route de Saint Côme - 78950 Gambais - France.
- Age at study initiation: no data
- Weight at study initiation: 329 to 400g
- Housing: housing by groups of 5 (or of 2 for the preliminary studies), in polystyrene cages
- Diet: Guinea-pig complete pelleted maintenance food, ad libitum
- Water: Softened and filtered drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3° C.
- Humidity (%): 30 to 70% R.H.
- Photoperiod (hrs dark / hrs light): 12h/12h
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Intrademal injection: 0.5% (V/V)
- Day(s)/duration:
- Single
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Topical application: 2.5% (V/V)
- Day(s)/duration:
- Single
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Challenge application: 0.25 and 0.5% (V/V)
- No. of animals per dose:
- Control: 10 males and 10 females
Treated: 10 males and 10 females - Details on study design:
- RANGE FINDING TESTS: concentrations: 0.25, 0.5, 1, 2.5, and 5% (V/V) (cf rapport H-IFT n°607331)
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2: 3 series of 2 intradermal injections + 1 occlusive topical application
- Exposure period: D1: intrademal injections, D9: occlusive topical application for 48 hours
- Test groups:
Intradermal: adjuvant +/- test article in the vehicle
Topical: test article in the vehicle
- Control group:
Intradermal: adjuvant +/- vehicle alone
Topical: vehicle alone
- Site: interscapular region
- Duration: 10 days
- Concentrations: intrademal injection: 0.5% (V/V) and topical application: 2.5% (V/V)
B. CHALLENGE EXPOSURE
- No. of exposures: 1 occlusive topical application of the test article and of the vehicle alone
- Day(s) of challenge: Day 22
- Exposure period: 24 hours
- Test groups: vehicle alone + test article in the vehicle
- Control group: vehicle alone + test article in the vehicle
- Site: test article on the left flank
- Concentrations: 0.25 and 0.5%
- Evaluation (hr after challenge): 5, 24 and 48 hours after removal of the occlusive patch - 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:
- 0.25%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.25%. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.25%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- 10/10 animals with reactions at challenge site, including 7/10 animals sensitized
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.25%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: 10/10 animals with reactions at challenge site, including 7/10 animals sensitized.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- 10/10 animals with reactions at challenge site, including 4/10 animals sensitized
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: 10/10 animals with reactions at challenge site, including 4/10 animals sensitized.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- Under these experimental conditions and according to the Magnusson and Kligman method, the test item MONO-n-HEPTYLAMINE
at the concentration of 0.25 % induced positive skin sensitization reactions in 7/10 guinea pigs, and at the concentration of 0.5% induced positive skin sensitization reactions in 4/10 guinea pigs. The test item is considered as sensitizing to the guinea pig. - Executive summary:
The delayed contact hypersensivity of was evaluated in Guinea pigs according to OECD N°406 guideline (Magnusson and Kligman test).
The induction phase has been realized both by intradermal route on day 1 (0.5% in vehicle) and by cutaneous route on day 9 (2.5%) in 2 groups of guinea pigs: 10 males and 10 females for control group and 10 males and 10 females for treated group. The challenge phase was realized on day 22 by cutaneous application of 0.25 and 0.5 % on the left flank (vehicle on the right flank); the cutaneous reactions were scored 5, 24 and 48 hours after the challenge phase.
From the macroscopic and histological results obtained under the experimental conditions it may be concluded that the test article provoked:
- In the 10 guinea-pigs of the group treated with the test article in a 0.25% solution, reactions of sensitization in 3 animals, reactions of mixed type (allergy and orthoergy) in 4 guinea-pigs and lesions of orthoergic intolerance in the 3 other animals, this last phenomenon can hide possible reactions of allergic type.
- In the 10 guinea-pigs of the group treated with the test article in a 0.5% solution, reactions of sensitization in 4 animals, and lesions of orthoergic intolerance in 5 other guinea-pigs, this last phenomenon can hide possible reactions of allergic type.
No significant abnormality was noted in the 10 animals of each one of both control groups treated at the same concentrations.
ln both cases and like during the previous study carried out with the test article in a 1% solution, the sample studied can be considered as a caustic allergen.
Under these experimental conditions and according to the Magnusson and Kligman method, the test item MONO-n-HEPTYLAMINE
at the concentration of 0.25 % induced positive skin sensitization reactions in 7/10 guinea pigs, and at the concentration of 0.5% induced positive skin sensitization reactions in 4/10 guinea pigs. The test item is considered as sensitizing to the guinea pig.
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.
