Registration Dossier
Registration Dossier
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EC number: 278-636-5 | CAS number: 77182-82-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 14 Nov. - 22 Nov. 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- GLP compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 July 1992
- Deviations:
- yes
- Remarks:
- no positive control, epicutaneous induction with a non-irritatnt concentration
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Humans and domestic animals § 81-6 "Dermal sensitization study"
- Version / remarks:
- November 1992
- GLP compliance:
- yes
- Remarks:
- Quality Assurance statement available, 30 Jan. 1984
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- LLNA method was not available yet by the time the study was conducted
Test material
- Reference substance name:
- Ammonium 2-amino-4-(hydroxymethylphosphinyl)butyrate
- EC Number:
- 278-636-5
- EC Name:
- Ammonium 2-amino-4-(hydroxymethylphosphinyl)butyrate
- Cas Number:
- 77182-82-2
- Molecular formula:
- C5H12NO4P.H3N
- IUPAC Name:
- ammonium 2-amino-4-[hydroxy(methyl)phosphoryl]butanoate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White guinea pigs
- Remarks:
- Hoe: DHPK (SPFLac)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Females (if applicable) nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known: SPF breeding colony
- Age at study initiation: not specified
- Weight at study initiation: average weight 263.2 g
- Housing: group housing
- Diet (e.g. ad libitum): ERKA 9300 complete guinea pig diet, ad libitum
- Water (e.g. ad libitum): tap water in platic bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Remarks:
- 0.9%
- Concentration / amount:
- 50% / 0.5 ml
- Day(s)/duration:
- Days 1, 3, 5, 8, 10, 12, 15, 17, 19 / 6h each
- Adequacy of induction:
- other: highest non-irritant concentration
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Remarks:
- 0.9%
- Concentration / amount:
- 50% / 0.5 ml
- Day(s)/duration:
- Day 37 / 6h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 animals in treatment group
10 animals in control group - Details on study design:
- RANGE FINDING TESTS: Dermal-occlusive application of 3 concentrations (0.5%, 5%, 50% in 0.9% physiological saline) to the flank of 2 animals; treatment for 24h
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 6h
- Control group: 0.5 ml of physiological saline alone
- Site: Left flank
- Frequency of applications: 2d interval between treatment
- Duration: until day 35
- Concentrations: 50%
B. CHALLENGE EXPOSURE
- No. of exposures: single treatment
- Day(s) of challenge: Day 37
- Exposure period: 6h
- Test groups: 0.5 ml of a 50% solution
- Control group: 0.5 ml of 0.9 ml physiological saline
- Site: Right flank
- Evaluation (hr after challenge): 24h, 48h
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no erythema or oedema
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no erythema or oedema
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no erythema or oedema
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no erythema or oedema
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Group:
- positive control
- Remarks on result:
- other: no positive control
Applicant's summary and conclusion
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