Phosphoric acid, C16-18-alkyl esters, potassium salts

Eye irritation

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Phosphoric acid, C16-18-alkyl esters, potassium salts

EC Number:

291-907-2

EC Name:

Phosphoric acid, C16-18-alkyl esters, potassium salts

Cas Number:

90506-45-9

Molecular formula:

not applicable for UVCB substances

IUPAC Name:

Reaction product of Phosphorus Pentoxide and C16 – 18 (even numbered) Alcohol, neutralized with Potassium Hydroxide

Details on test material:

Name of test material (as cited in study report): Silastol G 19 N
CAS No.: 90506-45-9

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)

Test animals / tissue source

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.

Test system

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

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

fully reversible

Results 5

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

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 7

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

Results 8

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

Results 9

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

Results 10

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

Results 11

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

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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).