1,2,3-Propanetriol, homopolymer, docosanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

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:

Polyglycerintribehenat

IUPAC Name:

Polyglycerintribehenat

Details on test material:

- Name of test substance: Polyglycerintribehenat
- Batch number: Partie 29
- Degree of purity/content: 85.8% behenic acid bound as behenic ester, 13.0% polyglycerin
- Date of manufacture: 02-Feb-1996
- Physical state/appearance: solid (congealed melt), beige at room temperature; liquid, beige at about 85 °C; powder, white after grinding the cooled down test substance
- Storage conditions: room temperature
- Stability and homogeneity: The stability of the test substance over the study period has been proven by reanalysis. After heating at about 85°C the test substance was homogeneous by visual inspection.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 3.89, 2.39, and 2.51 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area 3000 cm²
- Diet: about 130 g per animal per day Kliba-Labordiaet 341 (Klingentalmuehle AG, Kaiseraugst, Switzerland)
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of same animal

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL bulk volume (about 27 mg of the comminuted test substance)

Duration of treatment / exposure:

about 24 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 (1 male, 2 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: with tap water
- Time after start of exposure: about 24 hours

SCORING SYSTEM: according to OECD guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.4

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris and chemosis, and 0.4 for conjunctivae redness. The findings were reversible in all animals within 72 hours after application.

Any other information on results incl. tables

Tabulation of irritant response data for each individual animal at each observation time as well as calculation of the means (24, 48, 72 hours):

Readning	Animal	Cornea		Iris	Conjunctiva			Symptoms
		Opacity	Area		Redness	Chemosis	Discharge
1 h	01	0	0	0	2	2	0	Pupil contracted
	02	0	0	0	1	0	0
	03	0	0	0	2	2	2
24 h	01	0	0	0	1	0	0
	02	0	0	0	0	0	0
	03	0	0	0	2	0	0
48 h	01	0	0	0	0	0	0
	02	0	0	0	0	0	0
	03	0	0	0	1	0	0
72 h	01	0	0	0	0	0	0
	02	0	0	0	0	0	0
	03	0	0	0	0	0	0
Mean	01	0.0		0.0	0.3	0.0
	02	0.0		0.0	0.0	0.0
	03	0.0		0.0	1.0	0.0
Mean		0.0		0.0	0.4	0.0

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

Under the test conditions chosen the test substance did not give indication of an irritant property to the eye.

Executive summary:

The potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed in 3 white New Zealand rabbits subjected to a single ocular application of 0.1 mL bulk volume (about 27 mg) of the test substance on day 0.

The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris and chemosis, and 0.4 for conjunctivae redness. The findings were reversible in all animals within 72 hours after application. Thus the study was terminated. The observed symptoms do not indicate an irritant property of the test substance to the eye.

Conclusion: Under the test conditions chosen the test substance did not give indication of an irritant property to the eye.