Glycine, N-methyl-N-(1-oxododecyl)-, 1-methylethyl ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

24-02-1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Details on test material:

Nature of substance: undiluted

Specific details on test material used for the study:

Identity: ISOPROPYL N-LAUROYLSARCOSINATE
Description: pale yellow liquid
Batch number: 002013
Purity: 92.9 %
Stability of test item: stable under storage conditions
Expiry date: 31-03-2003

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Test system: New Zealand White Rabbit, SPF
Rationale: Recognized by the international guidelines as the recommended test system
Source: Elevage Scientifique des Dombes, Chatillon sur Chalaronne, France
Number of animals per test: 3 (1 m / 2 f)
Age at start of treatment: 10 - 12 weeks

Acclimatization: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
Standard Laboratory Conditions: Air-conditioned with target ranges for room temperature 17-23°C, relative humidity 30-70 % and approximately 10-15 air changes per hour. Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room cleaning. These transient variations are considered not to have any influence on the study and, therefore, these data are not reported but are retained at RCC. The animals were provided with an automatically controlled light cycle of 12 hours light and 12 hours dark. Music was played during the light period.
Accommodation: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing.
Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum.
Water: Community tap water ad libitum.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

eyes were not rinsed after treatment

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

The eyes of the animals were examined one day prior to test item administration. Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test. On the day of treatment, the test item was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation.
As it was suspected that the test item might produce irritancy, one single female was treated first. As neither a corrosive effect nor a severe irritant effect was observed after the 1 - and 24-hour examinations, the test was completed using the two remaining animals.

Examinations:
Viability/Mortality: Daily from delivery of the animals to the termination of test.
Clinical signs: Daily from delivery of the animals to the termination of test.
Body weights: At start of acclimatization, on the day of application and at termination of observation.
No necropsy was performed in the animals sacrificed at termination of observation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Remarks:

Primary eye irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

13

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item did not induce significant or irreversible damage to the rabbit eye.

Executive summary:

The primary eye irritation potential of the test item was investigated by instillation of 0.1 mL into one eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. The primary eye irritation score was calculated by totaling the mean cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of data points. The primary eye irritation score was 0.33 (max. 13).

The eye reactions (mean values from 24 to 72 hours) consisted of grade 0 corneal opacity, grade 0 iris lesions, grade 0.33 redness of the conjunctivae and grade 0 chemosis of the conjunctivae.

The instillation into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and swelling. These effects were reversible and were no longer evident 72 hours after treatment, the end of the observation period for all animals. No abnormal findings were observed in the cornea or iris of any animal at any reading. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed.

Thus, the test item did not induce significant or irreversible damage to the rabbit eye.

Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993), ISOPROPYL N-LAUROYLSARCOSINATE is considered to be "not irritating" to the rabbit eye.