Sorbitan monostearate, ethoxylated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

data is from experimental reports

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

To evaluate the acute eye irritation index of the test chemical in New Zealand White rabbit.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sorbitan monostearate, ethoxylated

EC Number:

500-020-4

EC Name:

Sorbitan monostearate, ethoxylated

Cas Number:

9005-67-8

Molecular formula:

C64-H126-O26 Unspecified

IUPAC Name:

Sorbitan monostearate, ethoxylated

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Sorbitan monostearate,ethoxylated
- Substance type: organic
- Physical state: Solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

-Source : Institute for Industrial Research & Toxicology
-Age : 10 to 12 weeks
-Body weight range : 2.0kg±200g
-Identification : By cage tag and corresponding colour body marking.
-Acclimatization : The healthy rabbits selected for study was acclimatized to standard laboratory condition for one week in experimental room under Veterinary examination.
-Randomization : After acclimatization and Veterinary examination three females were randomly selected.
-Accommodation : Animals were housed individually in stainless steel cages provided with stainless steel mesh bottom and facilities for food and water bottle.
-Diet : Pelleted feed
-Water : Community tap water passed through ‘Aqua Guard on line water filter’, was kept in glass bottles, ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22-25 deg.C
- Humidity (%): 40-60%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hours artificial fluorescent light and 12 hours dark.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

A dose of 0.1gm of test substance

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours after test substance application

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

Three female rabbits

Details on study design:

TEST SITE
- Area of exposure:conjunctival sac of one eye of each animal
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
SCORING SYSTEM:Scale of weighted scores for grading the severity of ocular lesions developed by //Draize et al
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: hand-slit lamp
Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. After recording the observations at 24 hours, the eyes were further examined with the aid of fluorescein.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

110

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The test compound when applied to the eye of New Zealand white rabbit at the dose level of 0.1 gm did not produce any eye irritation or any eye discharge throughout the observation period. Furthermore, any lesions such as pannus, staining were not recorded throughout the observation period of 72 hours

Other effects:

The test compound applied in conjunctival sac of rabbits did not show any observable clinical signs such as cage side activity and pain or stress etc. throughout the observation period of 21 days.

Any other information on results incl. tables

TABLE- 1     GRADING OF OCULAR LESIONS

S.NO/ SEX		OBSERVATION	Score				Total	Total Score
1/F			1 hour	24hours	48 hours	72 hours
	Cornea	A.      Opacity-Degree of Density	0	0	0	0	0	0
		B.      Area of Cornea Involved	0	0	0	0	0
	Iris	A.      Values	0	0	0	0	0	0
	Conjunctivae	A.      Redness	0	0	0	0	0	0
		B.      Chemosis	0	0	0	0	0
		C.      Discharge	0	0	0	0	0
2/F	Cornea	A.      Opacity-Degree of Density	0	0	0	0	0	0
		B.      Area of Cornea Involved	0	0	0	0	0
	Iris	A.      Values	0	0	0	0	0	0
	Conjunctivae	A.      Redness	0	0	0	0	0	0
		B.      Chemosis	0	0	0	0	0
		C.      Discharge	0	0	0	0	0
3/F	Cornea	A.      Opacity-Degree of Density	0	0	0	0	0	0
		B.      Area of Cornea Involved	0	0	0	0	0
	Iris	A.      Values	0	0	0	0	0	0
	Conjunctivae	A.      Redness	0	0	0	0	0	0
		B.      Chemosis	0	0	0	0	0
		C.      Discharge	0	0	0	0	0
Grand total								0
Mean								0.00
Eye Irritation Scoring index								0.00

 

 

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

Based on findings, it can be concluded that the test compound is practically non irritant when applied in the amount of 0.1 gm in the conjunctival sac of the rabbits under the test condition.

Executive summary:

Acute Eye Irritation/Corrosion Study of test chemical in Rabbits was performed as per OECD guideline no. 405. One healthy rabbit of body weight 1.96 kg was selected for study after acclimatization. Both eyes of rabbit were examined for any abnormal discharge such as eye irritation, ocular defects or pre-existing corneal injury from eye 24 hours prior to application of test compound.

The test compound was applied in the conjunctival sac of rabbit after gently pulling the lower lid away from the eyeball at the dose rate of 0.1gm. The lids were then gently held for about one second in order to prevent loss of the material. The other eye which remain untreated, served as a control. The acute irritation to eye conjunctiva, cornea and iris was evaluated at 1, 24, 48 and 72 hours after the treatment. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animal was observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. Individual animal weight before and during the study was observed.

The test compound did not produce any eye irritation or any eye discharge. Furthermore, no other clinical signs were recorded after application of test compound such as cage side activity, pain etc.

The result obtained from the initial test was confirmed in additional two animals (body weight ranges 200±gm) of same sex and same dose level .

In the confirmatory test the test compound was applied in the amount of 0.1 gm in the conjunctival sac of rabbit after gently pulling the lower lid away from the eyeball. The other eye which remain untreated, served as a control. The acute irritation to eye conjunctiva, cornea and iris was evaluated at 1, 24, 48 and 72 hours after the treatment. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animals were observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp.

In the confirmatory test, the test compound when applied to the conjunctival sac of the rabbits in the amount of 0.1 gm did not produce any eye irritation or inflammation during the entire observation period. However, there was no other clinical sign recorded in both of the animals during the whole observation period for 21 days.

Based on above findings, it can be concluded that the test compound can be considered as practically non irritant when applied in the amount of 0.1 gm in the conjunctival sac of the rabbits under the test condition.