Paraffin oils, sulfochlorinated, saponified

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Sept - Oct 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Paraffin oils, sulfochlorinated, saponified

EC Number:

269-144-1

EC Name:

Paraffin oils, sulfochlorinated, saponified

Cas Number:

68188-18-1

Molecular formula:

typical example: C15H31Na03S

IUPAC Name:

n-C14-C17 alkanes, secondary monosulphonic acids, sodium salts

impurity 1

Reference substance name:

Sodium chloride

EC Number:

231-598-3

EC Name:

Sodium chloride

Cas Number:

7647-14-5

Molecular formula:

ClNa

IUPAC Name:

sodium chloride

impurity 2

impurity 3

Reference substance name:

Sodium sulphate

EC Number:

231-820-9

EC Name:

Sodium sulphate

Cas Number:

7757-82-6

Molecular formula:

H2O4S.2Na

IUPAC Name:

sodium sulfate

Details on test material:

Purity: > 94 %

Specific details on test material used for the study:

Information from study report:
- CAS number 68188-18-1
- Appearance/Further information: white to yellow solid, pH 9.3 (saturated aqueous solution)
- Batch number: Pa. 268, DZA-UER-9000555-A
- Purity: 95 % (Mono-, Di- and Polysulfonate), content of organically bound chlorine 0.6 %
- Analysis Ref.: A89/0184/00 UER

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Sex: females
- Strain: HC:NZW
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England, UK
- Weight at study initiation: 3.0-3.9 kg
- Housing: individually in stainless steel cages with flat rod bases or plastic cages with perforated bases, under standardized conventional conditions
- Diet and water: ad libitum
- Acclimation period: at least 14 days in the quarantine station

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): approx. 50
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The second eye of each rabbit remained untreated and served as control.

Amount / concentration applied:

100 µl eq. to approx. 70 mg

Duration of treatment / exposure:

After instillation of the test substance into the conjunctival sac the eye-lids were gently held together for about one second in order to limit loss of the material. 24 hours after instillation the eye was rinsed with physiological saline.

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3

Details on study design:

After gently pulling the lower lid away from the eyeball a volume of 100 µL of the pulverized test substance, eq. to approx. 70 mg, was instilled into the conjunctival sac of one eye of each rabbit. The lids were then gently held together for about one second in order to limit loss of the material.

REMOVAL OF TEST SUBSTANCE
24 hours after instillation of the test substance the treated eye was rinsed with physiological saline.

SCORING SYSTEM: Draize
Eye irritation was scored 1, 24, 48, and 72 hours after administration and after 7, 14, and 21 days.

TOOL USED TO ASSESS SCORE:
The examinations were facilated using optical instruments (e.g. hand slit-lamp). To define epithelial damage, one drop of a 1% fluorescein solution was applied to the cornea surface 24 hours after administration of the test substance; where positive effects were recorded this was repeated at the later observation times. The eye was then rinsed with physiological sodium chloride solution to remove excess and nonabsorbed fluorescein. Evaluation was performed by means of ultraviolet illumination (area) in a darkened room and diffuse white illumination (intensity).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: #2, #3

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: mean score: 1.3

Results 3

Irritation parameter:

iris score

Basis:

animal: #1, #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 4

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

>= 0 - <= 1

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: mean score: 0.3

Results 5

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

>= 0 - <= 1

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: mean score: 0.3

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

>= 0 - <= 1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: mean score: 0.7

Irritant / corrosive response data:

Application of the test substance resulted in slight irritant reactions on eyes. Effects proved to be fully reversible on day 7.

Other effects:

not noted

Applicant's summary and conclusion

Executive summary:

In an eye irritation/corrosion study according to OECD TG 405 the test substance was instilled into the conjunctival sac of one eye of 3 female rabbits. 24 hours after instillation the eye was rinsed with physiological saline. Eye irritation was assessed after 1, 24, 48, and 72 hours and after 7, 14 and 21 days using the Draize scale. Application of the test substance resulted in slight irritant reactions on eyes (mean scores after 24, 48 and 72 hours: cornea 0 for 1/3 and 1.3 for 2/3 animals, iris 0 for 2/3 and 0.3 for 1/3 animals, conjunctivae/redness 2 for 3/3 animals, chemosis 0, 0.3, and 0.7 for each 1/3 animals). Effects proved to be fully reversible on day 7. Effects other than ocular ones were not noted.