Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study following the guideline without any deviation but not performed under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
purity > 98%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage du Gérome, France
- Age at study initiation: 11 to 13 weeks
- Weight at study initiation: 2,29 to 3,18 kg
- Housing: individual housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): 15 volumes per hour
- Photoperiod: 12 hrs dark/ 12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0,5 mL pure test item
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: back and flank of rabbits
- % coverage: 6 cm²
- Type of wrap if used: adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
0: no erythema/ no oedema
1: slight erythema/ oedema, just perceptible
2: erythema/ oedema well defined
3: moderate to severe erythema/ oedema
4: severe erythema with eschar formation / severa oedema with thickness > 1mm

Individual values were reported for each animal at 24, 48 and 72h for oedema and erythema. Then Primary Skin Irritation index was calculated from values of 24 and 72h, summed and divided by 2 values x 3 animals = 6
The scale was then:

primary skin irritation (PSI) <= 0,5 : not irritating
0,5 < PSI <= 2 : slightly irritant
2 < PSI <=5 : irritant
5< PSI <= 8: very irritant

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72h
Score:
1.8
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: no data on 48h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
2
Remarks on result:
other: no data on the erythema score
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Remarks on result:
other: no data on edema score
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
1
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
2
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
1
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
2
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
1
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
1
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
2
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
1
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
1
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
1
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
1
Irritant / corrosive response data:
Slight erythema well defined were noted for 3 animals and very slight oedema on 2 animals after 24h observation. All were fully reversible within 6 days.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
With a primary skin irritation index of 1,8, Phosphorous acid, tri-C12-14-alkyl esters was slightly irritant according to french protocol and scaling but not classified according to GHS criteria.
Executive summary:

Phosphorous acid, tri-C12-14-alkyl esters was tested in vivo for skin irritation using OECD 404 test guideline, but the study was not performed under GLP conditions. No deviation to the guideline was noted and the study was considered as reliable but quoted with reliability 2.

Three New Zealand white rabbits were tested with 0,5 mL pure test item and scoring was performed at 1, 24, 48 and 72 hour.

Slight erythema well defined were noted for 3 animals and very slight oedema on 2 animals after 24h observation. All were fully reversible within 6 days. No other clinical or systemic signs were noted.

With a primary skin irritation index of 1,8, Phosphorous acid, tri-C12-14-alkyl esters was considered as slightly irritant according to french protocol and scaling but not classified according to GHS criteria.