Dodecanoic acid, 1,1'-[1,6-hexanediylbis[nitrilo(2,2-dimethyl-1-propanyl-3-ylidene)]] ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-11-04 to 2004-10-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

24 April 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

468-880-2

EC Name:

-

Cas Number:

102985-93-3

Molecular formula:

C17H32O3

IUPAC Name:

Dodecanoic acid, (2,2-dimethyl-3-oxopropyl) ester

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Ferenc Sándor breeder, 2173 Kartal, Vörös Hadsereg Street 131, HUNGARY
- Age at study initiation: 10 weeks
- Weight at study initiation: 2594 - 2823 g
- Housing: Animals were housed individually in metal cages.
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8 - 12
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

The eyes were examined at 1, 24, 48, and 72 hours after the application.

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM:
The eye irritation scores will be evaluated according to the scoring system by Draize (1959) and OECD 405 (24 April 2002)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 11

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

One hour after treatment some hyperaemic blood vessels occurred in every animal. In two animals (animal No.: 16782, 17060) the discharge with moistening of the lids and hairs just adjacent to lids was found. In one case (animal No.: 16712) the discharge moistened the lids and considerable area around the treated eye. Chemosis, corneal and iris alterations were not found during the study. 24 hours after treatment in two animals (animal No.: 16712, 17060) some hyperaemic blood vessels occurred. In animal No.: 16712 the discharge from the eye was “any amount different from normal”. The animal No.: 16782 became fully symptom-free by this time. 48 and 72 hours after treatment every animal was symptom-free.

Other effects:

None.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item 2,2-Dimethyl-3-lauroyloxy-propanal, applied to the rabbits' eye mucosa, caused irritant effects, which can be evaluated as fully reversible alterations within 48h. According to the GHS criteria for classification and labelling requirements for dangerous substances and preparations the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.

Executive summary:

The acute eye irritation study of the test item 2,2-Dimethyl-3-lauroyloxy-propanal was performed in three New Zealand White rabbits. The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 405, 2002). The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. The treated eyes of the test animals were not washed out following the instillation of 0.1 mL of the test item, which was administered in pure state, in a single dose. The eyes were examined at 1, 24, 48, and 72 hours after the application. One hour after the single application of 2,2-Dimethyl-3-lauroyloxy-propanal into the eyes of the rabbits slight redness and moderately or severely increased discharge were observed in the eyes of the test animals. Chemosis, corneal and iris alterations were not found during the study. 24 hours after treatment in two animals slight redness was observed and in one case slightly increased discharge was noted. One animal became fully symptom-free by this time. 48 hours after the treatment every animal was symptom-free. 72 hours after the treatment the study was terminated, since no primary irritation symptoms occurred. The general state and the behaviour of animals were normal during the whole study. In conclusion, the test item 2,2-Dimethyl-3-lauroyloxy-propanal, applied to the rabbits' eye mucosa, caused irritant effects, which can be evaluated as fully reversible alterations within 48 h. According to the GHS criteria for classification and labelling requirements for dangerous substances and preparations the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.