Phosphoric acid, mono- and di-C11-14 (linear and branched) alkyl esters

Endpoint summary

Description of key information

- Skin irritation:  irritating in rabbits (one study acc. to OECD guideline 404 and EU method B.4, GLP), applied to the intact skin for 4 hours. Mean scores (24, 48 and 72 h) for three animals following the 4 hours exposure were 4/4/3 for erythema and 4/3.6/2.3 for edema. Edema was fully reversible in all animals within 7 days. . After 14 days, very slight erythema (grade 1) and slight desquamation were still present in one animal.  In a primary dermal irritation study Phosphoric acid, C11-14-isoalkyl esters, C13-rich was irritating (category 2) to rabbit skin.      
- Eye irritation: irritating in rabbits (one study acc. to OECD guideline 405 and EU method B.5, GLP); undiluted test material applied to right eye of one animal. Scattered or diffuse corneal opacity was noted in the treated eye one hour after treatment with translucent corneal opacity noted at the 24, 48, 72 h and 7 d observations and opaque corneal opacity at the 14 d observation. Vascularisation, with a generalised ingrowth of vessels for up to approximately 5 mm, was noted in the treated eye at the 14 d observation. Pannus formation around approximately three quarters of the cornea and extending up to 5 mm towards the centre of the cornea was also noted in the treated eye at the 14 d observation. Iridial inflammation was noted in the treated eye one hour after treatment and at all subsequent observations.  Severe conjunctival irritation was noted in the treated eye one hour after treatment and at the 24 and 48 h observations with moderate conjunctival irritation noted at the 72 h, 7 and 14 d observations.  The reactions noted in the treated eye at the 14 d observation were considered to be indicative of irreversible ocular damage.

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:

From 3/3/2006 to 25/10/2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP, Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Granja Cunícula San Bernardo, S.L
- Age at study initiation: 10-13 weeks
- Weight at study initiation: 2.3-3.1 Kg
- Housing: individually in a stainless steel cages
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-25
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL of the test item

Duration of treatment / exposure:

4 hours

Observation period:

60 minutes, 24, 48,72 hours, 7 and 14 days after the period of exposure.

Number of animals:

three

Details on study design:

Erythematous lesions and eschars (most severely affected areas) - No erythema: 0 - Very slight erythema (hardly noticeable): 1 - Well defined erythema: 2 - Moderate to intense erythema: 3 - Intense erythema (reddening) or formation of eschars that impede scoring: 4 Edematous lesions - No edema: 0 - Very slight edema (hardly noticeable): 1 - Slight edema (the edges of the zone are well defined by concrete elevations): 2 - Moderate edema (1 mm elevations, approximately): 3 - Intense edema (elevations of more than 1 mm and that extend beyond of exposure): 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean 24, 48, 72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: mean 24, 48, 72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean 24, 48, 72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: only very slight erythema (grade 1) and slight desquamation remaining

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: mean 24, 48, 72 h

Score:

3.6

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean 24, 48, 72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean 24, 48, 72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Initially after 24 and 48 hours after removal of the patch during 3 minutes well defined erythema (grade 2) was observed, along with very slight edema (grade 1). After 72 hours the erythema had decreased, and only very slight erythema (grade 1) and dryness were recorded. At 7 and 14 days after removing the cited patch, no skin lesions were recorded. After 24, 48 and 72 hours, intense erythema (grade 4) was observed in one of the animals, along with intense edema (grade 4) at 24 and 48 hours, and moderate edema (grade 3) at 72 hours. after 7 days the erythema had decreased to well defined erythema (grade 2) and desquamation was observed on the area administered. After 14 days very slight erythema (grade 1) and slight desquamation were observed in one of the animals.

Bodyweight (kg)
		Observation period
Animal no.	Day of treatment	24h	48h	72h	7d	14d
2378	2,73	2,73	2,77	2,73	2,94	3,12
2162	2,31	2,33	2,38	2,43	2,54	2,77
2166	3,14	3,22	3,23	3,28	3,45	3,77
Primary Dermal Irritation Test
Animal no. (Exposure)	Response	60 min	24 h	48 h	72 h	7 d	14 d
2378 (3 minutes)	Erythema	0	2	2	1'	0	0
	Edema	0	1	1	0	0	0
2378 (1hour)	Erythema	1	2	2	2'	0	0
	Edema	0	2	2	1	0	0
2378 (4hours)	Erythema	3	4	4	4	2^2,3	0
	Edema	4	4	4	4	0	0
^1:Dryness
^2':Desquamation
^3':Areas of epidermal regeneration
Primary Dermal Irritation Test
Animal no. (Exposure)	Response	60 min	24 h	48 h	72 h	7 d	14 d
*2378 (4 hours)	Erythema	3	4	4	4	2^3,5	0
	Edema	4	4	4	4	0	0
2162 (4 hours)	Erythema	3	4	4	4	2^3	1^4
	Edema	4	4	4	3	0	0
2166 (4 hours)	Erythema	3	3	3^1	3^2,3	1^3	0^4
	Edema	4	3	2	2	0	0
^1:Slight dryness
^2':Dryness
^3':Desquamation
^4:Slight desquamation
^5:Areas of epidermal regeneration
^*: Corresponds to the animal administered, to which 3 patches were sequentially applied.

 

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

The alterations induced by the test item were evaluated following the OECD Guideline 404 and Method B.4. In view of the results obtained, the test item is considered to be irritant , based on the criteria set out in directive 2001/59/EC, Annex VI, and it is therefore assigned the risk phrase R38. According to CLP, EU GHS (Regulation (EC) No 1272/2008) the test item has to be classified as Category 2 (irritant).

Executive summary:

In a primary dermal irritation study according to the OECD Guideline for the Testing of Chemicals 404 and Commission Directive 2004/73/EC Method B.4, 3 female, young adult New Zealand white rabbits were dermally exposed to 0.5 mL of Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters (100% a.i.) for 4 hours. Animals then were observed for 14 days.

At 60 minutes after removal of the patch exposed during 4 hours, moderate to intense erythema (grade 3) was observed, along with intense edema (grade 4). At 24, 48 and 72 h the erythema had evolved to intense erythema (grade 4), and the intense edema persisted at all the observations.

After 7 days well defined erythema (grade 2) was recorded, along with desquamation and areas of epidermal regeneration. Full recovery was observed after 14 d.

Similar findings were observed on 2 further animals: After 24, 48 and 72 h, intense erythema (grade 4) was observed in one animal along with intense edema (grade 4) at 24 and 48 h and moderate edema (grade 3) at 72 h. After 14 d very slight erythema (grade 1) and slight desquamation were still present in this animal.

Moderate to intense erythema (grade 3) was recorder in the third animal after 24, 48 and 72 h, accompanied with moderate edema (grade 3) at 24 h and slight edema (grade 2) at 48 and 72 h. After 14 d the erythema had remitted, only slight desquamation was observed.

The means of the erythema and edema evaluations at 24, 48 and 72 hours for the three animals after a four-hour exposure were 4/4/3 (erythema) and 4/3.6/2.3 (edema).

In this study, Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters is an skin irritant (Category 2) based on the criteria of Regulation (EC) No. 1272/2008.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (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:

Between 21 August 2012 and 04 September 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 24 April 2002

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

One New Zealand White (Hsdlf:NZW) strain rabbit was supplied by Harlan Laboratories UK Ltd., Leicestershire, UK. At the start of the study the animal weighed 2.39 kg and was twelve to twenty weeks old. After an acclimatisation period of at least five days the animal was given a number which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animal was housed in a suspended cage. Free access to mains drinking water and food (2930C Teklad Global Certified Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animal was provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye remained untreated and served as control

Amount / concentration applied:

A volume of 0.1 mL of the test item was placed into the conjunctival sac of the right eye

Duration of treatment / exposure:

the eyes were not rinsed after treatment

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

1

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: according to OECD guideline 405

TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: mean 24, 48, 72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: mean 24, 48, 72 h

Score:

1

Max. score:

2

Reversibility:

not reversible

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean 24, 48, 72 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean 24, 48, 72 h

Score:

2.67

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

other: discharge

Basis:

animal #1

Time point:

other: mean 24, 48, 72 h

Score:

2.67

Max. score:

4

Reversibility:

not reversible

Irritant / corrosive response data:

Individual scores for ocular irritation are given in Table 1.
Scattered or diffuse corneal opacity was noted in the treated eye one hour after treatment with translucent corneal opacity noted at the 24, 48, 72 h and 7 d observations and opaque corneal opacity at the 14 d observation. Vascularisation, with a generalised ingrowth of vessels for up to approximately 5 mm, was noted in the treated eye at the 14 d observation. Pannus formation around approximately three quarters of the cornea and extending up to 5 mm towards the centre of the cornea was also noted in the treated eye at the 14 d observation.
Iridial inflammation was noted in the treated eye one hour after treatment and at all subsequent observations.
Severe conjunctival irritation was noted in the treated eye one hour after treatment and at the 24 and 48 h observations with moderate conjunctival irritation noted at the 72 h, 7 and 14 d observations.
The reactions noted in the treated eye at the 14 d observation were considered to be indicative of irreversible ocular damage.

Other effects:

Bodyweight
Individual bodyweights and bodyweight change are given in Table 2.
The animal showed expected gain in bodyweight during the study

Interpretation of Results

If evidence of irreversible ocular damage is noted, the test item will be classified as corrosive to the eye.

The results were interpreted according to the Globally Harmonised System of Classification and Labelling of Chemicals and Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Dangerous Substances.

Table 1              Individual Scoresfor Ocular Irritation

Rabbit Number and Sex	72420Male
	IPR= 2
Time After Treatment	1 Hour	24 Hours	48 Hours	72 Hours	7 Days	14 Days
CORNEA
Degree of Opacity	1	2	2	2	2	4VPa
Area of Cornea Involved	4	4	4	4	4	4
IRIS	1	1	1	1	1	1
CONJUNCTIVA
Redness	2	2	2	2	2	2
Chemosis	3	3	3	2	2	2
Discharge	3	3	3	2	1	1

IPR=  Initial pain reaction

V =      Vascularisation, with a generalised ingrowth of vessels for approximately up to 4 mm to 5 mm

Pa =    Pannus formation around approximately ¾ of the cornea and extending up to 5 mm towards the centre of the cornea

Table 2              Individual Bodyweights and Bodyweight Change

Rabbit Number and Sex	Individual Bodyweight (kg)		Bodyweight Change (kg)
	Day 0	Day 14
72420Male	2.39	2.79	0.40

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

The test item produced irreversible ocular damage and was considered to be CORROSIVE to the rabbit eye.
The test item was classified as Category 1 (irreversible effects on the eye) according to the Globally Harmonised System of Classification and Labelling of Chemicals.
The test item was also classified as Irreversible effects on the eye (Category 1) according to Regulation (EC) No. 1272/2008. It is reasonable to assume that the Signal Word “Danger” and the Hazard Statement “H318: Causes serious eye damage” are therefore required.

Executive summary:

In a primary eye irritation study according to OECD Guideline 405 (Acute Eye Irritation / Corrosion), adopted 24 April 2002, and EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion), 0.1 mL of Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters (100% a.i.) was instilled into the conjunctival sac of the the right eye of one young adult male New Zealand White rabbit. The eye was not washed after treatment. The animal then was observed for 14 days.  Irritation was scored by the method of Draize.

Scattered or diffuse corneal opacity was noted in the treated eye one hour after treatment with translucent corneal opacity noted at the 24, 48, 72 h and 7 d observations and opaque corneal opacity at the 14 d observation. Vascularisation, with a generalised ingrowth of vessels for up to approximately 5 mm, was noted in the treated eye at the 14 d observation. Pannus formation around approximately three quarters of the cornea and extending up to 5 mm towards the centre of the cornea was also noted in the treated eye at the 14 d observation.

Iridial inflammation was noted in the treated eye one hour after treatment and at all subsequent observations.

Severe conjunctival irritation was noted in the treated eye one hour after treatment and at the 24 and 48 h observations with moderate conjunctival irritation noted at the 72 h, 7 and 14 d observations. 

The reactions noted in the treated eye at the 14 d observation were considered to be indicative of irreversible ocular damage.

In this study, Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters is an eye irritant and produced irreversible effects on the eye (Category 1) based on the criteria of Regulation (EC) No. 1272/2008.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

In a primary dermal irritation study according to the OECD Guideline for the Testing of Chemicals 404 and Commission Directive 2004/73/EC Method B.4, 3 female, young adult New Zealand white rabbits were dermally exposed to 0.5 mL of Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters (100% a.i.) for 4 hours. Animals then were observed for 14 days. 

At 60 minutes after removal of the patch exposed during 4 hours, moderate to intense erythema (grade 3) was observed, along with intense edema (grade 4). At 24, 48 and 72 h the erythema had evolved to intense erythema (grade 4), and the intense edema persisted at all the observations.

After 7 days well defined erythema (grade 2) was recorded, along with desquamation and areas of epidermal regeneration. Full recovery was observed after 14 d.

Similar findings were observed on 2 further animals: After 24, 48 and 72 h, intense erythema (grade 4) was observed in one animal along with intense edema (grade 4) at 24 and 48 h and moderate edema (grade 3) at 72 h. After 14 d very slight erythema (grade 1) and slight desquamation were still present in this animal. Moderate to intense erythema (grade 3) was recorder in the third animal after 24, 48 and 72 h, accompanied with moderate edema (grade 3) at 24 h and slight edema (grade 2) at 48 and 72 h. After 14 d the erythema had remitted, only slight desquamation was observed. The means of the erythema and edema evaluations at 24, 48 and 72 hours for the three animals after a four-hour exposure were 4/4/3 (erythema) and 4/3.6/2.3 (edema).

In this study, Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters is an skin irritant (Category 2) based on the criteria of Regulation (EC) No. 1272/2008.

Further skin irritation studies on the chemically similar substance Phosphoric acid, C9-15-branched and linear alkyl esters, potassium salts are available:

Skin corrosivity potential of Phosphoric acid, C9-15 branched and linear alkyl esters, potassium salts solution (36%) (Lot.930526 -1) was tested in rabbits in accordance with OECD guideline 404.

0.5 mL of 100% solution of test substance (36% a.i.) was put on a Lint cloth (2.5cm x 2.5cm) and then applied to the intact back skin. Lint cloth was covered by Silkytex (ALCARE CO., LTD.). Duration of treatment was 3 min, 1 hr, or 24 hr.

There was no dermal toxicity. The results were:

1) 3 min exposure: No skin reaction was observed in any evaluation time point: Not corrosive

2) 1 hr exposure: No skin reaction was observed in any evaluation time point: Not corrosive

3) 4 hr exposure: eschar formation, a very slight edema: Not corrosive

 

Primary skin irritation potential of Phosphoric acid, C9-15 branched and linear alkyl esters, potassium salts solution (33%) was tested in rabbits.

60.6% (w/w) (20% a.i.), 30.3% (w/w) (10% a.i.) and 6.06% (w/w) (2% a.i.) were examined in this study, and water for injection was used as solvent control.

A clear erythema and a slight edema in intact skin, and medium to strong erythema and a slight edema in abraded skin were observed by 60.6% of this substance. A clear erythema and a slight edema were observed in intact and abraded skin by 30.3% of this substance. No skin reaction was observed by 6.06% of this substance and solvent control (water for injection).

P.I.I. (Primary Irritation Index) of 60.6%, 30.3%, 6.06% and water was 2.59, 2.08, 0 and 0, respectively.

Based on these results, 60.6% (w/w) (20% a.i.) and 30.3% (w/w) (10% a.i.) solution were judged as medium irritant, and 6.06% (w/w) (2% a.i.) was classified as non-irritant.

 

Cumulative skin irritation potential of Phosphoric acid, C9-15 branched and linear alkyl esters, potassium salts solution (33%) was tested in rabbit.

60.6% (w/w) (20% a.i.), 30.3% (w/w) (10% a.i.) and 6.06% (w/w) (2% a.i.) were applied to rabbit skin once a day for two weeks (except for Sunday), total 12 times. Water for injection was used as solvent control.

A clear erythema and a slight edema was observed after 3 -4 applications, moderate to strong erythema and a slight edema was after 5 applications, a strong erythema with a slight eschar and a moderate edema was after 6 -11 applications, a strong erythema with a slight eschar and a slight edema was after 12 applications by 60.6% (w/w) solution (20% a.i.).

A clear erythema was observed after 3 applications, a clear erythema and a very slight edema was after 4 applications, a moderate to strong erythema and a slight eschar and a slight edema was after 6 -9 applications, a strong erythema with a slight eschar and a very slight edema was after 10 -11 applications, a clear erythema was after 12 applications by 30.3% (w/w) solution (10% a.i.).

No skin reaction was observed by 6.06% (w/w) solution (2% a.i.) and water for injection.

Eye irritation

An in vitro study was performed initially to assess the corneal irritation and damage potential of Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters by means of the BCOP assay using fresh bovine corneae.

The test item was tested as 10% (v/v) suspension in saline in accordance with the guideline for surfactants. The positive control 2-Ethoxyethanol was tested neat. Saline was used as negative control item.

The positive control (2-Ethoxyethanol) showed clear opacity and distinctive permeability of the corneae (mean in vitro irritation score 60.24) corresponding to a classification as corrosive /severe irritant to the eye (CLP/EPA/GHS (Cat 1)).

Relative to the negative control, the 10% (v/v) suspension of Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters in saline caused a slight increase of the corneal opacity. Permeability effects could not be observed. The calculated mean in vitro irritation score was 9.37. According to OECD 437 the 10% (v/v) suspension of the test item in saline is classified as not corrosive / not severe irritant to the eye.

Because the testing result (score of 9.37) was well below an IVIS of ≥ 55.1 additional testing had to be conducted for classification and labelling purposes in accordance with the accepted integrated testing strategy (ITS) for assessing the eye irritation potential of substances (REACH TGD R7a).

In a primary eye irritation study according to OECD Guideline 405 (Acute Eye Irritation / Corrosion), adopted 24 April 2002, and EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion), 0.1 mL of Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters (100% a.i.) was instilled into the conjunctival sac of the the right eye of one young adult male New Zealand White rabbit. The eye was not washed after treatment. The animal then was observed for 14 days. Irritation was scored by the method of Draize.

Scattered or diffuse corneal opacity was noted in the treated eye one hour after treatment with translucent corneal opacity noted at the 24, 48, 72 h and 7 d observations and opaque corneal opacity at the 14 d observation. Vascularisation, with a generalised ingrowth of vessels for up to approximately 5 mm, was noted in the treated eye at the 14 d observation. Pannus formation around approximately three quarters of the cornea and extending up to 5 mm towards the centre of the cornea was also noted in the treated eye at the 14 d observation.

Iridial inflammation was noted in the treated eye one hour after treatment and at all subsequent observations.

Severe conjunctival irritation was noted in the treated eye one hour after treatment and at the 24 and 48 h observations with moderate conjunctival irritation noted at the 72 h, 7 and 14 d observations.

The reactions noted in the treated eye at the 14 d observation were considered to be indicative of irreversible ocular damage.

In this study, Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters is an eye irritant and produced irreversible effects on the eye (Category 1) based on the criteria of Regulation (EC) No. 1272/2008.

There are no data gaps for the endpoint irritation/corrosion. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.

Justification for selection of skin irritation / corrosion endpoint:
OECD & EC guideline study, no deviations, GLP

Justification for selection of eye irritation endpoint:
OECD & EC guideline study, no deviations, GLP

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin irritation

Based on reliable, adequate and relevant data, Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters has to be classified as irritating to the skin (Category 2) according to CLP, EU GHS (Regulation (EC) No 1272/2008) and is assigned the hazard statement H315 and the signal word “Warning”. According to the criteria set out in directive 2011/59/EC, Annex VI, Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters is considered to be irritant to the skin and is therefore assigned the risk phrase R38.

 

Eye irritation

Based on reliable, adequate and relevant data, Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters has to be classified in Category 1, irreversible effects on the eye according to CLP, EU GHS (Regulation (EC) No 1272/2008) and is assigned the hazard statement H318 and the signal word “Danger”.

According to the criteria set out in directive 67/548/EEC Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters is classified as “Risk of serious damage to eyes” and is therefore assigned the risk phrase R41.

There are no data gaps for the endpoint irritation/corrosion. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.