Registration Dossier
Registration Dossier
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EC number: 931-335-9 | CAS number: 90622-74-5
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
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 guinea-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:
- LLNA was not available and adopted as an OECD guideline at the time of the current study.
Test material
- Reference substance name:
- Amides, C8-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl)
- EC Number:
- 931-329-6
- 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'-iminodiethanol
- Reference substance name:
- Glycerol
- EC Number:
- 200-289-5
- EC Name:
- Glycerol
- Cas Number:
- 56-81-5
- IUPAC Name:
- propane-1,2,3-triol
- Test material form:
- not specified
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)
Inductionopen allclose all
- 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)
Challengeopen allclose all
- 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):
- yes
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
- Remarks on result:
- no indication of skin sensitisation
- 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
- Remarks on result:
- no indication of skin sensitisation
- 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
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Remarks:
- No details were provided
Any other information on results incl. tables
For detailed results tables kindly refer to the attached background materials section of the IUCLID.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, test substance did not produce any evidence of delayed contact hypersensitivity and was therefore considered non-sensitising.
- Executive summary:
A study was conducted to evaluate the skin sensitisation potential of the test substance, C8-18 and C18-unsatd. DEA, according to OECD Guideline 406 using guinea pig maximisation assay. The procedure consisted of two parts: induction and challenge exposures. For induction, three sets of intradermal injections were given (0.1mL 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 days after the cutaneous exposure, 25% test substance in vaseline was placed on the skin of the right flank (open application). Under the study conditions, test substance did not produce any evidence of delayed contact hypersensitivity and was therefore considered non-sensitising (Potokar, 1982).
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