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Toxicological information

Skin sensitisation

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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:
1983
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

Constituent 1
Chemical structure
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-(hydroxymethylphosphinyl)butyrate

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