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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst breed
- Weight at study initiation: 2.5 - 3.2 kg
- Housing: singly in cages
- Diet (e.g. ad libitum): ERKA 3800 (Futtermittelwerk Robert Koch oHG, Hamm/Westf.) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not specified
Vehicle:
unchanged (no vehicle)
Remarks:
but premixed with one drop of 0.9% NaCl solution
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

VEHICLE
- Amount(s) applied (volume or weight with unit): one drop
- Concentration (if solution): 0.9% NaCl solution
Duration of treatment / exposure:
1 minute (3 animals) or 24 hours (6 animals)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
9
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after one minute (3 animals) or 24 hours (6 animals)

SCORING SYSTEM: According to Draize

TOOL USED TO ASSESS SCORE: loupe / fluorescein-sodium
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Remarks:
no opacity was observed for any animal
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.6
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48h

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
GLP compliance:
not specified

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst breed
- Weight at study initiation: 2.5 - 3.2 kg
- Housing: singly in cages
- Diet (e.g. ad libitum): ERKA 3800 (Futtermittelwerk Robert Koch oHG, Hamm/Westf.) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Remarks:
50% of shorn area was aditionally scarified
Vehicle:
physiological saline
Remarks:
0.1 mL of 0.9% NaCl solution
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 0.9% NaCl solution
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 6 x 3 cm, half of the area was additionally scarified
- Type of wrap if used: test substance was applied to cellulose patches in Hansamed(R) surgical plaster measuring 2.5 x 2.5 cm. The plaster strips were secured in position and then covered with an indifferent, impervious PVC-foil (6-8 cm in width). Subsequently, the trunk of the animal was bandaged with an elastic polyurethane-wrap thrand-bandage (permanent dressing K, Lohmann).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS
immediately after removal of the dressing and at 48 and 72 hours after treatment

SCORING SYSTEM:
- Method of calculation:

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Remarks:
scarified skin
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.6
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Remarks:
scarified skin
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
erythema score
Remarks:
scarified skin
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
erythema score
Remarks:
scarified skin
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Remarks:
scarified skin
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
erythema score
Remarks:
scarified skin
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Remarks:
intact / scarified skin
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Remarks:
no edema was observed in any animal

Applicant's summary and conclusion