Registration Dossier

Administrative data

Description of key information

Phosphorous acid, tri-C12-14-alkyl esters was tested in vivo for skin and eye irritation using OECD 404/ 405 test guidelines respectively.

For skin irritation: 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.

For eye irritation: three New Zealand white rabbits were tested with 0,1 mL pure test item and scoring was performed at 1, 24, 48 and 72 hour.

Slight conjunctivae effects were noted on 3 animals 1 hour after instillation (enanthema slight to moderate with slight chemosis) and were fully reversible within 48h after treatment.

In the two cases, no other clinical or systemic signs were noted.

With a primary skin irritation index of 1,8, and maximum mean irritation score of 9.3 for eyes, Phosphorous acid, tri-C12-14-alkyl esters was considered as slightly irritant for skin and eyes, according to French protocol and scaling but not classified according to GHS criteria.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified
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
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye 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
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage du Gérome, France
- Age at study initiation: 12 to 13 weeks
- Weight at study initiation: 2,45 to 2,91 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
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0,1 mL pure test item
Duration of treatment / exposure:
One instillation made, then observation during 72h and more if necessary
Observation period (in vivo):
Up to 22 day if effects visible
Number of animals or in vitro replicates:
3 females
Details on study design:
Observations at 1, 24, 48 and 72h were made to determine
- conjunctive chemosis
- conjunctive enanthema
- iris lesion
- corneal opacity
The 4 observation times were suumed for the three animals for determining of the maximal ocular irritation index. (OI max)
The scale is then given:
OI max <= 15 : slightly irritant
15< OI max <= 30 : moderate irritant
30< OI max <= 50 : irritant
50< OI max: very irritant
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1, 24, 48 and 72h
Score:
9.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris 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:
0.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48h
Irritant / corrosive response data:
Slight conjuntival effects were noted on 3 animals 1 hour after instillation (enanthema slight to moderate with slight chemosis) and were fully reversible within 48h after treatment.
Interpretation of results:
GHS criteria not met
Conclusions:
With a maximum mean irritation score of 9.3, Phosphorous acid, tri-C12-14-alkyl esters was slightly irritant to eyes 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 eye irritation using OECD 405 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 0,1 mL pure test item and scoring was performed at 1, 24, 48 and 72 hour.

Slight conjuntival effects were noted on 3 animals 1 hour after instillation (enanthema slight to moderate with slight chemosis) and were fully reversible within 48h after treatment. No other clinical or systemic signs were noted.

With a maximum mean irritation score of 9.3, Phosphorous acid, tri-C12-14-alkyl esters was slightly irritant to eyes according to french protocol and scaling but not classified according to GHS criteria.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The two in vivo studies for skin and eye irritation performed with Phosphorous acid, tri-C12-14-alkyl esters showed that the substance could be slighlty irritant, but not met the criteria for any classification.