Tetradecanedioic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 21 January 2013 to 11 February 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: A well documented GLP study according to OECD guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

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:

Tetradecanedioic acid

EC Number:

212-476-9

EC Name:

Tetradecanedioic acid

Cas Number:

821-38-5

Molecular formula:

C14H26O4

IUPAC Name:

tetradecanedioic acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): TETRADECANEDIOIC ACID
- Physical state: white powder
- Analytical purity: 98.9 %
- Purity test date: 2012-09-05
- Lot/batch No.: 3412090269
- Expiration date of the lot/batch: 22 October 2015
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

other: albino New Zealand rabbit

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: the Elevage de Gérome (Quartier Labaste – F40260 Linxe)
- Age at study initiation: 14 weeks old
- Weight: between 2.54 kg and 3.25 kg
- Housing: the animal was kept in an individual box installed in conventional air conditioned animal husbanding
- Diet: foodstuff (SAFE – 112)
- Water: tap-water from public distribution system
- Acclimation period: minimal 5-day acclimatisation period

ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23 °C
- Humidity: 30 to 70 %
- Air changes: between 10 and 15 changes per hour
- Photoperiod: the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The other eye remained untreated serving as control.

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 g

Observation period (in vivo):

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

Number of animals or in vitro replicates:

1 animal.
Initially, a single animal was treated. After consideration of the responses produced on day 21 in the first animal, two additional animals were not treated.

Details on study design:

0.1 g of the test item was instilled, as supplied, into the conjunctival sac of one eye after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the test item. The other eye remained untreated serving as control.
Initially, a single animal was treated. After consideration of the responses produced on day 21 in the first animal, two additional animals were not treated.
Remaining test item (on the nictitating membrane and on the lower eyelid) requiring a physiological rinse was noted on day 0.

If no reaction is observed 72 hours after instillation, the study is terminated. In case of persistent reactions, additional observations can be carried out from D7 to D21 in order to determine the reversible character of the lesions observed.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

conjunctivae score

Remarks:

- redness

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

iris score

Remarks:

- lesion

Basis:

mean

Time point:

other: 24, 48 and 72h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

cornea opacity score

Remarks:

- opacity

Basis:

mean

Time point:

other: 24, 48 and 72h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Irritant / corrosive response data:

The ocular reactions observed during the study have been moderate and partially reversible:
- at the conjunctivae level: a moderate redness noted 1 hour after the test item instillation and totally reversible on day 14, associated with a moderate chemosis noted 1 hour after the test item instillation, and totally reversible on day 7.
- at the iris level: a congestion noted on day 1 and totally reversible on day 7.
- at the corneal level: a moderate corneal opacity, noted 24 hours after the test item instillation and remaining on day 21 (last day of the test, slight intensity).
White secretions requiring a physiological rinse were noted on day 1.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: other: CLASSIFICATION in accordance with the CLP regulation

Conclusions:

In conclusion, taking into account the irreversibility of lesions observed, the results obtained, under these experimental conditions, enable to conclude that the test item TETRADECANEDIOIC ACID must be classified R41 "Risk of serious damage to eyes", according to the criteria for the Directive 67/548 and category 1 “irreversible effects on the eye”, H318 in accordance with the Regulation (EC) No. 1272/2008.