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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996-11-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992-07-17
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Diethyl phenylphosphonite
EC Number:
216-676-7
EC Name:
Diethyl phenylphosphonite
Cas Number:
1638-86-4
Molecular formula:
C10H15O2P
IUPAC Name:
diethyl phenylphosphonite
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Diethoxyphenlyphosphin- DEOPP
- Physical state: liquid, colourless
- Analytical purity: 98.4 g/100g (GC)
- Lot/batch No.: 96-1008-9-HL
- Date of manufacturing: 1996-07-11
- Storage condition of test material: room temperature, exclusion of moisture, light and oxygen (store under nitrogen)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: females 3.98 kg, males 4 kg
- Housing: single housing, stainless steel wire mesh cages with grating, floor area 3000 cm2
- Diet: about 130 g/day (Kliba Labordiaet 341, Klingentalmuehle AG Kaiseraugst, Switzerland), ad libitum
- Water: about 250 ml tap water per animla per day, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%):30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied:0.5 mL


Duration of treatment / exposure:
4 hours
Observation period:
15 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5*2.5 cm
- Type of wrap if used: test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern, Germany) and Fixomull (R) stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing: removal with Lutrol (R) E 400 (=Polyethylenglycol DAB, BASF SE) and Lutrol / water (1/1)
- Time after start of exposure: exposure period 4 h

SCORING SYSTEM: table according to OECD guideline 404 (1992-04-17)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2.9
Max. score:
4
Reversibility:
not fully reversible within: 15 d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.9
Max. score:
4
Reversibility:
fully reversible within: 15 d
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 15 d
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 15 d
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 15 d
Irritation parameter:
erythema score
Basis:
other: all animals
Time point:
other: day 15
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 15 d
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritant / corrosive response data:
The average score (24 to 72 hours) for irritation was calculated to be 2.9 for erythema and 0.9 for edema. Erythema were not reversible in all animals within 15 days after removal of the patches (study termination).
Other effects:
Other effects were erythema extending beyond the area of exposure in all animals (at time 1 h after exposure until termination of the study), edema extending beyond the area of exposure (until 24 hours after exporsure in all animals, at time 48 h in animal 1 and 2, at time 72 h in animal 2), scaling (at the 8th day in animals 1 and 2, 15 days after exposure in all animals) and scaling beyond the area of exposure (at the 8th day in animals 1 and 2, 15 days after exposure in all animals).

Any other information on results incl. tables

Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

60 min

2/2/2

 3/3/3

24 h

 3/3/3

1/2/1 

48 h

 3/3/3

 1/1/0

72 h

3/3/2 

 1/1/0

Average 24h, 48h, 72h

 3/3/2.7

 1/1.3/0.3

Reversibility*)

n.c. 

 c.

Average time for reversion

 not fully reversible within 15 d

 15 d

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information