Registration Dossier
Registration Dossier
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EC number: 475-290-9 | CAS number: 39537-23-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-02-01 to 1994-02-25
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- non-irritant 50% aqueous solution used for induction
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- non-irritant 50% aqueous solution used for induction
- GLP compliance:
- yes
- 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:
- -
- EC Number:
- 475-290-9
- EC Name:
- -
- Cas Number:
- 39537-23-0
- Molecular formula:
- C8H15N3O4
- IUPAC Name:
- (2R)-2-[(2S)-2-aminopropanamido]-4-carbamoylbutanoic acid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd/Win: DH
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen, Germany
- Age at study initiation: 9 weeks (males and females)
- Weight at study initiation: 493 - 533 g (males); 419 - 469 g (females)
- Housing: individually in Macrolon cages type IV
- Diet: standard diet, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.0 - 19.5
- Humidity (%): 52 - 70
- Photoperiod: 12 hrs dark / 12 hrs light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 1%
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 50%
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 30%
- Day(s)/duration:
- 24 h
- No. of animals per dose:
- control group: 6 (3 m / 3 f) animals (2 control groups used)
treatment group: 10 (5 m / 5 f) animals - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
intracutaneous application
- No. of exposures: 1
- Test groups: 2 x Freund's Complete Adjuvant (FCA)/physiological saline solution (1:1); 2 x test substance solution; 2 x test substance solution/ FCA (1:1)
- Control groups: 2 x FCA/physiological saline solution (1:1); 2 x 0.9% physiological saline solution; 2 x 0.9% physiological saline solution/ FCA (1:1)
- Application site: scapular area
- Site: area of 4 x 6 cm of the scapular region
- Concentration: 1%
- Application volume: 0.1 mL
epicutaneous application
- No. of exposures: 1
- Test group: test substance in 0.9 % physiological saline solution
- Control groups: 0.9 % physiological saline solution
- Application site: scapular area
- Site: vehicle right flank; test substance left flank
- Duration: 48 h
- Concentration: 50%
- Application volume: 1.0 mL
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 22
- Exposure period: 24 h
- Test group: test substance in 0.9 % physiological saline solution
- Control groups: test substance in 0.9 % physiological saline solution
- Site: vehicle right flank; test substance left flank
- Concentrations: 30%
- Application volume: 0.2 mL
- Evaluation (h after challenge): 24 and 48 - Positive control substance(s):
- yes
- Remarks:
- 1,4-phenylenediamine in a separate experiment (study no. 898470, Nov. 1993)
Results and discussion
- Positive control results:
- The proof of the sensitivity of the Guinea Pig strain was tested in a separate investigation (study no. 898470, Nov. 1993) with 1,4-phenylenediamine as positive control substance. All animals showed signs of sensitisation.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Group:
- positive control
- Remarks on result:
- other: tested in separate experiment (study no. 898470, Nov. 1993)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions used in the Guinea Pig Maximisation Test (GPMT) the test substance showed no sensitising potential.
CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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