N-(1-oxooctyl)glycine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06-13 august 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: complete study according OECD 405 and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N-(1-oxooctyl)glycine

EC Number:

238-122-3

EC Name:

N-(1-oxooctyl)glycine

Cas Number:

14246-53-8

Molecular formula:

C10H19NO3

IUPAC Name:

N-(1-oxooctyl)glycine

Constituent 2

Reference substance name:

LCA07012

IUPAC Name:

LCA07012

Details on test material:

Sponsor’s identification: LCA07012
• Date received : 24 & 27 July 2007
• Container : plastic flask (n=3)
• Form : powder
• Quantity : 726.0 g (container + contents)
• Colour : white
• Batch n° : 0716300006
• Storage : room temperature
• Production date: 12 June 2007
• Expiry date: 11 June 2010 (re-test)
• Purity: 99%
It was identified under the code number: PH-07/0301.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand Red

Details on test animals or tissues and environmental conditions:

One female albino New Zealand rabbit was supplied by the Elevage de Gérome (Quartier Labaste –
F40260 Linxe). It was kept during a minimal 5-day acclimatisation period. During the test, the animal
weighed between 2.48 kg and 2.54 kg.
The animal was kept in an individual box installed in conventional air conditioned animal husbanding;
the environmental conditions were:
- temperature : between 19°C and 23°C
- relative humidity : between 41% and 72%
- lighting time: 12 hours daily
Drinking water (tap-water from public distribution system) and foodstuff were supplied freely.
Microbiological and chemical analyses of the water were carried out once every six months by the
Institut Européen de l'Environnement de Bordeaux (I.E.E.B.).

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1 g of the test item was instilled into the conjunctival sac of one eye, the other eye remained
untreated serving as control.

Duration of treatment / exposure:

Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following
treatment,

Observation period (in vivo):

until 72h

Number of animals or in vitro replicates:

3

Details on study design:

0.1 g of the test item was instilled into the conjunctival sac of one eye, the other eye remained
untreated serving as control.
Initially, a single animal was treated. After consideration of the ocular responses produced in the first
treated animal, two additional animals were not treated.
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following
treatment, according to the numerical evaluation given in page 8.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 2

Max. score:

2

Reversibility:

not fully reversible within: 24h

Remarks on result:

other: moderate redness a

Results 2

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 1.7

Max. score:

2

Reversibility:

fully reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 2

Max. score:

2

Reversibility:

not specified

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

1

Reversibility:

not specified

Irritant / corrosive response data:

0.1g/eye:
- moderate conjunctival redness from 24 hr, partially reversed by day 7,
- moderate chemosis from 1 hr, reversed by day 7,
- moderate corneal opacity from 1 hr and corneal ulceration from day 4, neither reversed by day 7,
- iridial congestion from days 1 to 3,
- whitish secretion on days 1 and 2.

Other effects:

none

Any other information on results incl. tables

The ocular reactions observed during the study have been moderate and partially reversible. Taking into account the reaction registered (corneal ulceration), the test was stopped at D7, in accordance with the principles of animal welfare.

It was noted:

- at the conjunctivae level: a moderate redness, 24 hours after the test item instillation and partially reversible at the end of the observation (D7) associated with a moderate chemosis, noted 1 hour after the test item instillation and totally reversible at D7,

- at the corneal level: a moderate opacity, registered 1 hour after the test item instillation and still registered at the end of the observation time,

- at the iris level: a congestion noted between D1 and D3. It was noted a corneal ulceration, from the 5th day of the test. This lesion persisted for 72 hours. Furthermore, it was noted a whitish secretion requiring a rinse with isotonic sodium chloride, at D1 and D2.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The results obtained, under these experimental conditions, enable to conclude that the test item
LCA07012:
- is irritant for the eye (Max. O.I = 49) according to the classification established in the Journal
Officiel de la République Française dated July 10th, 1992.
- and, must be classified R41 "Risk of serious damage to eyes" taking into account the reaction
registered (corneal ulceration), according to the criteria for the classification, packaging and labelling
of dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/59 and 99/45. It
must be characterised by the symbol “Xi” and the danger label “irritant”.

Executive summary:

The test item LCA07012 was instilled, into the eye of one New Zealand rabbit at the dose of 0.1 g. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline n° 405 dated April 24th, 2002 and the test method B.5 of the directive 2004/73/EC. The ocular reactions observed during the study have been moderate and partially reversible. Taking into account the reaction registered (corneal ulceration), the test was stopped at D7, in accordance with the principles of animal welfare. It was noted: - at the conjunctivae level: a moderate redness, 24 hours after the test item instillation and partially reversible at the end of the observation (D7) associated with a moderate chemosis, noted 1 hour after the test item instillation and totally reversible at D7, - at the corneal level: a moderate opacity, registered 1 hour after the test item instillation and still registered at the end of the observation time, - at the iris level: a congestion noted between D1 and D3. It was noted a corneal ulceration, from the 5th day of the test. This lesion persisted for 72 hours. Furthermore, it was noted a whitish secretion requiring a rinse with isotonic sodium chloride, at D1 and D2. In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item LCA07012 must be classified R41 "Risk of serious damage to eyes" taking into account the reaction registered (corneal ulceration), according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/59 and 99/45. It must be characterised by the symbol “Xi” and the danger label “irritant”.