Registration Dossier
Registration Dossier
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EC number: 701-177-3 | 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:
- 09 Feb - 19 Mar 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- lack of test material and study details, no reliability check
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data were included to avoid unnecessary testing.
Test material
- Reference substance name:
- N-methyl-N-[C18-(unsaturated)alkanoyl]glycine
- EC Number:
- 701-177-3
- Molecular formula:
- C21H39NO3
- IUPAC Name:
- N-methyl-N-[C18-(unsaturated)alkanoyl]glycine
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 weeks
- Weight at study initiation: 270-400 g
- Housing: animals were housed individually in Macrolon III cages.
- Diet: standard guinea-pig pellets - NAFAG No. 830 (Gossau SG), ad libitum and supplemented with fresh carrots.
- Water: ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50 ± 10
- Photoperiod (hrs dark / hrs light): 14/14
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 20% ethanol / 80% saline (intradermal), vaseline PhH VI (epidermal)
- Concentration / amount:
- 5% and 30%
Challenge
- Route:
- epicutaneous, occlusive
- Concentration / amount:
- 3%
- No. of animals per dose:
- 20
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture adjuvant (Bacto Adjuvant complete Freund, Difco) and saline
Injection 2: test substance in saline
Injection 3: a mixture of the test substance with the adjuvant saline mixture
Epicutaneous: test substance in vaseline
- Control group: no information
- Site: neck region
- Frequency of applications: every 7 days
- Duration: Days 0-8
- Concentrations: intradermal 5%, epicutaneous 30%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 20
- Exposure period: 24 h
- Test groups: test substance
- Control group: vehicle only
- Site: flank
- Concentrations: 3%
- Evaluation (hr after challenge): 48 h
OTHER: The application sites were chemically depilated 3 h before examination. - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No tests with a positive control group had been performed. The study had been performed in 1981!
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 5 and 30%; challenge: 3%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 5 and 30%; challenge: 3%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- 3 animals with very slight erythema and 2 animals with well defined erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Clinical observations: 3 animals with very slight erythema and 2 animals with well defined erythema.
- Group:
- positive control
- Remarks on result:
- other: no data in study report
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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