Phosphorous acid, tri-C12-14-alkyl esters

Endpoint summary

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

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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

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

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.