Isoleucine, N-(1-oxohexadecyl)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2008

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:

L-Alanine, N-coco acyl derivs., sodium salts

EC Number:

290-478-9

EC Name:

L-Alanine, N-coco acyl derivs., sodium salts

Cas Number:

90170-45-9

Test material form:

other: no dusty granules

Details on test material:

- Name of test material (as cited in study report): LCA 08003

- Physical state: solid (granular)
- purity: 100%
- Lot/batch No.: 1564JG
- Expiration date of the lot/batch: 13 may 2009
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome
- Age at study initiation: 13 weeks old
- Weight during the study: 2.76 - 3.18 kg
- Housing: individual box installed in conventional air conditioned animal husbandings
- Diet (e.g. ad libitum): ad libitum foodstufs
- Water (e.g. ad libitum): ad libitum: tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 38-64
- Air changes (per hr):10 changes
- Photoperiod (hrs dark / hrs light): 12 hours daily lighting time

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the other eye remained untreated and serves as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1g/eye

VEHICLE
no vehicule used

Duration of treatment / exposure:

single administration

Observation period (in vivo):

Observation at 1h,24h, 48, 72h and until 21 days after treatment

Number of animals or in vitro replicates:

3 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
no data

SCORING SYSTEM:
As described in the OECD guideline 405: numerical evaluation.
Eye evaluations are carried out using the scale of lesions scores:
- conjonctivae: chemosis, discharge, redness,
- iris
- cornea: degree and extent of opacity

All the values obtained for the conjonctivae, iris and cornea of each animal are calculated.
The highest mean value of the maximum ocular irritation index (max OI) is used to classify the item, according to the scale published by the Journal Officiel de la République Française.
The mean scores of conjonstivae, iris and cornea were calculated in compliance with the EEC regulations.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

other: between 1 h and D21 after instillation

Score:

59

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: in compliance with the scale of the Journal Officiel de la Réoublique Française

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: in compliance with EEC regulations

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: in compliance with the EEC regulations

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: in compliance with EEC regulations

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: in compliance with EEC regulations

Irritant / corrosive response data:

The ocular reactions observed during the study were moderate and partially reversible:
- at the conjonctivae level: moderate redness associated with a moderate chemosis, registered 1 hour after the test item instillation and totally reversible at D14.
- at the corneal level: moderate opacity, registered 24 hour after the test item instillation and still noted at the end of the observation time (same intensity)
- at the iris level: a congestion noted 1 hour after the test item instillation and totally reversible at D7. A corneal-neovascularisation was noted between D7 and D21 (end of the observation time)

Applicant's summary and conclusion

Interpretation of results:

highly irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: classification established in the Journal officiel de la République Française dated July 10th 1992

Conclusions:

Teh test item is highly irritant for the eye (Max. O.I = 59) and must be classified R41"risk of serious damage to eyes" taking into account the irreversibility of the reactions