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Description of key information

Phosphoric acid, C16-18-alkyl esters, potassium salts is no classified for skin irritation.

Phosphoric acid, C16-18-alkyl esters, potassium salts is classified for causing severe eye irritation.

Key value for chemical safety assessment

Skin irritation / corrosion

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:
2000-11-28 - 2000-12-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Chemical name:C16-Alkyl-phosphorsaureester, Kaliumsalz
C18-Alkyl-phosphorsaureester, Kaliumsalz
CAS. No.: 17026-47-0, 68987-29-1, 7732-18-5
Test concentration: 40 % (=26 % C16- und 14 % C18-Verbindung)
Species:
rabbit
Strain:
other: Chbb-.HM(SPF) - Littlerussian
Details on test animals or tissues and environmental conditions:
Housing
The study took place in animal room No. 8 provided with filtered air at a temperature of 20°C ± 3°C, relative humidity of 55% ± 15% and air changes 10 times/hour. The room was illuminated to give a cycle of 12 hours light and 12 hours darkness. Light was on from 6 a.m. to 6 p.m.
During a pre-period of at least one week and throughout the experiment the rabbits were caged individually in PPO cages (floor area: 2576 sq.cm) with perforated floor.
Diet
A pelleted complete rabbit diet "Altromin 2123" from Altromin, D-32791 Lage, Lippe, was available ad libitum. Analyses for major nutritive components and relevant possible contaminants are performed regularly on the diet. Certificates of analysis are retained.
Drinking water
The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth. Analyses for relevant possible contaminants are performed regularly. Certificates of analysis are retained.

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
14 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days

One hour after application of the test article animal No. 2014 showed an iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse beefy red conjunctiva, a swelling with lids about half closed and a discharge with moistening of the lids and hairs, and considerable area around the eye. A diffuse, crimson red conjunctiva with individual vessels not easily discernible, an obvious swelling with partial eversion of lids and a discharge different from normal were observed in animal No. 1993. Animal No. 1996 showed an iris with markedly deepened folds, congestion swelling, moderate circumcorneal injection and existence of reaction light, a diffuse, crimson red conjunctiva with individual vessels not easily discernible, an obvious swelling with partial eversion of lids and a discharge with moistening of the lids and hairs, and considerable area around the eye.

24 hours after application of the test article a scattered or diffuse area of opacity on more than half, but less than three quarters of the cornea, an iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse beefy red conjunctiva, a swelling with lids about half closed and a discharge different from normal were observed in animal No. 2014. Animal No. 1993 showed a scattered or diffuse area of opacity on more than one quarter, but less than half of the cornea, an iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse beefy red conjunctiva, a swelling with lids about half closed and a

discharge with moistening of the lids and hairs, and considerable area around the eye. A scattered or diffuse area of opacity on more than one quarter, but less than half of the cornea, an iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse beefy red conjunctiva, an obvious swelling with partial eversion of lids and a discharge with moistening of the lids and hairs just adjacent to lids were observed in animal No. 1996.

After instillation of Fluorescein animals No. 2014 and No. 1996 showed a scattered or diffuse area of opacity on more than three quarters of the cornea. Easily discernible translucent areas with details of iris slightly obscured on more than three quarters of the cornea were observed in animal No. 1993.


48 hours after application of the test article animal No. 2014 showed an iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse, crimson red conjunctiva with individual vessels not easily discernible as well as an obvious swelling with partial eversion of lids. A scattered or diffuse area of opacity on more than one quarter, but less than half of the cornea, an iris with markedly deepened folds, congestion swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse beefy red conjunctiva, an obvious swelling with partial eversion of lids and a discharge with moistening of the lids and hairs, and considerable area around the eye were observed in animal No. 1993. Animal No. 1996 showed a scattered or diffuse area of opacity on more than one quarter, but less than half of the cornea, an iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse beefy red conjunctiva, an obvious swelling with partial eversion of lids and a discahrege with moistening of the lids and hairs just adjacent to lids. After instillation of Fluorescein a scattered or diffuse area of opacity on more than three quarters of the cornea was observed in animals No. 2014 and No. 1996. Animal No. 1993 showed easily discernible translucent areas with details of iris slightly obscured on more than half, but less than three quarters of the cornea.

72 hours after application of the test article a diffuse, crimson red conjunctiva with individual vessels not easily discernible as well as an obvious swelling with partial eversion of lids were observed in animal No. 2014. Animal No. 1993 showed a scattered or diffuse area of opacity on one quarter or less of the cornea, an iris with markedly deepened folds, congestion swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse, crimson red conjunctiva with individual vessels not easily discernible, an obvious swelling with partial eversion of lids and a discharge with moistening of the lids and hairs just adjacent to lids. A

scattered or diffuse area of opacity on one quarter or less of the cornea, a diffuse, crimson red conjunctiva with individual vessels not easily discernible, an obvious swelling with partial eversion of lids and a discharge different from normal were observed in animal No. 1996.

After instillation of Fluorescein animal no. 2014 showed a scattered or diffuse area of opacity on more than half, but less than three quarters of the cornea. Easily discernible translucent areas with details of iris slightly obscured on more than half, but less than three quarters of the cornea were observed in animal No. 1993. Animal No. 1996 showed a scattered or diffuse area of opacity on more than three quarters of the cornea.

7 days after application of the test article some conjunctival vessels definitely injected were observed in animals No. 2014 and No. 1993. Animal No. 1996 showed a scattered or diffuse area of opacity on more than one quarter, but less than half of the cornea and a diffuse, crimson red conjunctiva with individual vessels not easily discernible. After instillation of Fluorescein a scattered or diffuse area of opacity on more than half, but less than three quarters of the cornea was observed in animal No. 1996.

14 days after application of the test article all three animals No. 2014, No. 1993 and No. 1996 were free of any signs of eye irritation.

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The local effect of SILASTOLHC 19-P 40 was investigated according to the method recommended in the OECD Guideline No. 405, "Acute Eye Irritation/ Corrosion", Feb. 1987, and EEC Guideline B.5 "Acute Toxicity (Eye Irritation)", Jan. 1997.
Three female albino rabbits were exposed to 0.1 ml of the test article in one eye. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours as well as 7 and 14 days after dosing.
Well-defined to moderate signs of irritation were observed on the treated eyes.
The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated:
Cornea opacity: 0.8
Iris lesion: 0.8
Redness of conjunctiva: 2.6
Oedema of conjunctiva: 2.2
Executive summary:

The local effect of SILASTOL HC 19-P 40 was investigated according to the method recommended in the OECD Guideline No. 405, "Acute Eye Irritation/ Corrosion", Feb. 1987, and EEC Guideline B.5 "Acute Toxicity (Eye Irritation)", Jan. 1997.

Three female albino rabbits were exposed to 0.1 ml of the test article in one eye. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours as well as 7 and 14 days after dosing.

Well-defined to moderate signs of irritation were observed on the treated eyes.

The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated:

Cornea opacity: 0.8

Iris lesion: 0.8

Redness of conjunctiva: 2.6

Oedema of conjunctiva: 2.2

Therefore, SILASTOL HC 19-P 40 is classified as causing serious eye irritation (category 2).

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, New Zealand White were dermally exposed to Phosphoric acid, C16-18-alkyl esters, potassium salts (undiluted) to for 24 hours under an occlusive dressing to shaved and shaved and abraded skin areas.  Animals then were observed for 72 hours. Irritation was scored by the method of Draize.  

On shaved areas no irritation was observed in all animal whereas on the abraded areas in 4/6 animals erythema score 1 was observed at the 24 hour reading. Effects were reversible within 72 hours.

 

Eye irritation:

In a primary eye irritation study Silastol 11137 was investigated using the method of Draize.

Three female albino rabbits were exposed to 0.1 mL of the test article in one eye. The eyes were examined and the changes were graded according to a numerical scale 24, 48 and 72 hours, 4, 5, and 7 days after dosing.

Very slight conjunctival effects were observed on the treated eyes. All effects were fully reversible within 72 hours at the latest.

The local effect of SILASTOLHC 19-P 40 was investigated according to the method recommended in the OECD Guideline No. 405, "Acute Eye Irritation/ Corrosion", Feb. 1987, and EEC Guideline B.5 "Acute Toxicity (Eye Irritation)", Jan. 1997.

Three female albino rabbits were exposed to 0.1 ml of the test article in one eye. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours as well as 7 and 14 days after dosing.

Well-defined to moderate signs of irritation were observed on the treated eyes.

The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated:

Cornea opacity: 0.8

Iris lesion: 0.8

Redness of conjunctiva: 2.6

Oedema of conjunctiva: 2.2

Therefore, SILASTOL HC 19-P 40 is classified as causing serious eye irritation (category 2).

 

Justification for selection of skin irritation / corrosion endpoint:

Reliable data from an  in-vivo study conducted similar to OECD guideline 404

Justification for selection of eye irritation endpoint:

Reliable data from a study study conducted similar to OECD guideline 405

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin irritation:

No effects were observed in a primary irritation study with Phosphoric acid, C16-18-alkyl esters, potassium salts under and extended exposure of 24 hours and occlusive dressing.

According to CLP; EU GHS (Regulation (EC) No 1272/2008) and directive 67/548/EEC no classification is required for skin irritation.

 

Eye irritation:

The local effect of SILASTOL HC 19-P 40 was investigated according to the method recommended in the OECD Guideline No. 405, "Acute Eye Irritation/ Corrosion", Feb. 1987, and EEC Guideline B.5 "Acute Toxicity (Eye Irritation)", Jan. 1997.

Three female albino rabbits were exposed to 0.1 ml of the test article in one eye. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours as well as 7 and 14 days after dosing.

Well-defined to moderate signs of irritation were observed on the treated eyes.

The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated:

Cornea opacity: 0.8

Iris lesion: 0.8

Redness of conjunctiva: 2.6

Oedema of conjunctiva: 2.2

Based on the respective mean scores classification is required according to CLP; EU GHS (Regulation (EC) No 1272/2008) as well as for directive 67/548/EEC.

Therefore, SILASTOL HC 19-P 40 is classified as causing serious eye irritation (category 2).

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