Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- Principles of method if other than guideline:
- The method employed in this study for the detection of delayed contact hypersensitivity was the guineo-pig maximization test described by Magnusson B and Kligman AM (1970) in "Allergic Contact Dermatitis in the Guinea-Pig: Identification of contact allergens", published by C. C. Thomas, Springfield, Illinois, U. S.A.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid GMPT study was available before REACH came into force, therefore no additional LLNA study was conducted.
Test material
- Reference substance name:
- Amides, C8-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl)
- EC Number:
- 931-329-6
- Cas Number:
- 68155-07-7
- Molecular formula:
- The alkyl chain length of the amide ranges between 8 and 18 carbon atoms
- IUPAC Name:
- Amides, C8-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl)
- Reference substance name:
- 2,2'-iminodiethanol
- EC Number:
- 203-868-0
- EC Name:
- 2,2'-iminodiethanol
- Cas Number:
- 111-42-2
- Molecular formula:
- C4H11NO2
- IUPAC Name:
- 2-(2-hydroxyethylamino)ethanol
- Reference substance name:
- Glycerol
- EC Number:
- 200-289-5
- EC Name:
- Glycerol
- Cas Number:
- 56-81-5
- Molecular formula:
- C3H8O3
- IUPAC Name:
- glycerol
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Average weight at study initiation: 440 g
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: Propylene glycol
- Concentration / amount:
- induction: Intradermal injection - Site 1) 0.1 ml Freund's adjuvant; site 2) 0.1 ml of a 5% solution of test substance in propylene glycol; site 3) 0.1 ml of a 1:1 mix of Freund's adjuvant and 5% test substance solution
Challenge: After 1 week, 5% test substance in vaseline (occlusive patch for 48 h); after 14 days 25% test substance in vaseline (open application)
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Propylene glycol
- Concentration / amount:
- Induction: Intradermal injection - Site 1) 0.1 ml Freund's adjuvant; site 2) 0.1 ml of a 5% solution of test substance in propylene glycol; site 3) 0.1 ml of a 1:1 mix of Freund's adjuvant and 5% test substance solution
Challenge: After 1 week, 5% test substance in vaseline (occlusive patch for 48 h); after 14 days 25% test substance in vaseline (open application)
- No. of animals per dose:
- 20
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Test groups: 20
- Control group: 20
- Site: both sites of the spinal cord at the level of the shoulder blades
B. CHALLENGE EXPOSURE
- No. of exposures: once, one week after induction, then again 14 days later (re-challenge)
- Exposure period: after one week; exposure over the injection sites via occlusive patch for 48 h; after 14 days: open application on right flank
- Evaluation (h after challenge): Animals observed after induction and challenge, up until 72 h after re-challenge (at 14 days) - Challenge controls:
- Identical to test group.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Intracutaneous application of Freund's adjuvant caused strong skin reddening, skin swelling and later necrosis and scarring
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: After removal of the occlusive patch
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No specific skin reactions
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Reading:
- rechallenge
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Remarks:
- (non-sensitising)
- Conclusions:
- Under the study conditions, the test substance did not produce any evidence of delayed contact hypersensitivity and was therefore considered non-sensitizing.
- Executive summary:
A study was performed to determine the delayed contact hypersensitivity potential of the test substance, C8-18 and C18-unsatd. DEA, in 20 female Pilbright guinea-pigs, according to OECD Guideline 406 (GPMT: guinea pig maximisation test). The procedure consisted of two parts: induction and challenge exposures. For induction, three sets of intradermal injections were given (0.1 ml Freund's adjuvant; 0.1 ml of a 5% solution of test substance in propylene glycol, and 0.1 ml of a 1:1 mix of Freund's adjuvant and 5% test substance. One week after the injections, a 5% test solution was placed on the skin over the injection sites via an occlusive patch and left for 48 h. This was followed by a re-challenge: 14 d after the cutaneous exposure, 25% test substance in vaseline was placed on the skin of the right flank (open application). Under the study conditions, the test substance did not produce any evidence of delayed contact hypersensitivity and was therefore considered non-sensitizing (Potokar, 1982).
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