Stearic acid, esters with methyl α-D-glucoside

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

February 24, 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Stearic acid, esters with methyl α-D-glucoside

Molecular formula:

Molecular formula cannot be given as substance is a mixture.

IUPAC Name:

Stearic acid, esters with methyl α-D-glucoside

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
- Diet: ad libitum, Ssniff MÜZ (Alleindiat für Zuchtkaninchen), Ssniff Spezialdiäten GmbH, Soest/Westfalen, Germany
- Water: ad libitum, drinking water for human consumption
- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ±2°
- Humidity (%): 50- 85%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- The test substance was applied undiluted
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

no washing

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

- The test article was placed into the conjunctival sac of the left eye, while the right eye was used as a control.
- Using an ophthalmoscope, ocular reactions were assessed 1, 24, 48 and 72 h after treatment.

REMOVAL OF TEST SUBSTANCE
- no

SCORING SYSTEM:
- Eye irritation/corrosion was graded according to the EEC directive 83/467/EEC from July 29, 1983 and to GefStoffV, 1987 (BGBI.1.p. 2721), as stipulated by OECD 405.

TOOL USED TO ASSESS SCORE: ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

- No iridial irritation or corneal opacity were observed.
- An irritation of the conjunctivae, which consisted of redness and chemosis was observed in the eye of each rabbit within the first hour. The irritation was fully reversible within 24 hours.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0	0/0/0	2/1/2	1/1/1
24 h	0/0/0	0/0/0	0/0/0	0/0/0
48 h	0/0/0	0/0/0	0/0/0	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0/0/0	0/0/0	0/0/0	0/0/0
Reversibility*)			c.	c.
Average time (unit) for reversion			24 h	24 h

*) Reversibility: c. = completely reversible; n.c.= not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

In this study Stearic acid, esters with methyl α-D-glucoside (according to producer information 100 % w/w) is not an eye irritant.
Interpretation is based on effects on the cornea, iris and conjunctiva calculated as mean scores following grading at 24, 48 and 72 hours after instillation of the test material, in consideration of reversibility. Mean scores for all animals were zero.

Executive summary:

In a primary eye irritation study according to OECD Guideline 405, 0.1 g of Stearic acid, esters with methyl α-D-glucoside (according to producer information 100 % w/w), was instilled undiluted into the conjunctival sac of one eye of three New Zealand White rabbits. The untreated eye served as control. The eyes were not washed. Animals were then observed for 72 hours. Irritation was scored as stipulated by OECD Guideline 405.

No iridial irritation or corneal opacity was observed. An irritation of the conjunctivae, which consisted of redness and chemosis was observed in one eye of each rabbit within the first hour. The irritation was fully reversible within 24 hours.

 

In this study Stearic acid, esters with methyl α-D-glucoside (according to producer information 100 % w/w) is not an eye irritant.