1,4-phenylenebis(nitrilo-2,2-dimethylprop-1-yl-3-ylidene) didodecanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2016-03-08 to 2016-04-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2nd October 2012

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

1998

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,4-phenylenebis(nitrilo-2,2-dimethylprop-1-yl-3-ylidene) didodecanoate

Cas Number:

1154521-93-3

Molecular formula:

C40H68N2O4

IUPAC Name:

1,4-phenylenebis(nitrilo-2,2-dimethylprop-1-yl-3-ylidene) didodecanoate

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: S & K LAP Kft. 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: Young adult rabbits, 11 weeks old
- Weight at study initiation: 2540-2900 g
- Housing: Animals were housed individually in metal cages.
- Diet: The animals received C.HYF rabbit mixed diet produced by Cargill Takarmány Zrt., 5300 Karcag, Madarasi út 0399., Hungary, ad libitum.
- Water: Animals received tap water from watering bottles ad libitum. The drinking water is periodically analysed and is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
- Acclimation period: 5 days in first animal and 6 days in second and third animal

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes: above 10 changes/hour
- Photoperiod: Artificial light, from 6 a.m. to 6 p.m.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: A volume of 0.1 mL of the test item solution was used for the study, in a single dose.

Duration of treatment / exposure:

The eyes of the test animals were not washed out 24 hours after the application of test item, because the test substance was removed from the eye of the test animal by physiological mechanisms and the test item did not cause immediately severe irritation or corrosion after test item application.

Observation period (in vivo):

72 h

Duration of post- treatment incubation (in vitro):

not applicable

Number of animals or in vitro replicates:

Three healthy male animals were selected for the test.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: Not performed

SCORING SYSTEM: The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (2nd October 2012).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

All animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

All animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

iris score

Basis:

mean

Remarks:

All animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal 1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal 2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal 3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritant / corrosive response data:

One hour after treatment, some conjunctival hyperaemic blood vessels (score 1) were observed in two animals (No.: 376, 375).
24 hours after treatment, all animals were free of symptoms.
48 hours after treatment, some conjunctival hyperaemic blood vessels (score 1) were observed in animal No.: 376. Two animals (No.: 379, 375) were free of symptoms.
72 hours after treatment, all animals were free of symptoms.
72 hours after treatment, the study was terminated, since no primary irritation symptoms occurred.
During the study the control eyes of the animals were symptom-free.
No systemic toxicity was observed on the day of the treatment and during the 72-hour observation period. The body weight of animals corresponded to their species and age. Signs of pain and distress as discharge were not observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In conclusion, the test item SIKA Hardener LPP, applied to the rabbits’ eye mucosa, caused slight conjunctival irritant effect which was fully reversible within 72 hours. According to Regulation (EC) No 1272/2008, the test item has not been classified into any category.

Executive summary:

The acute eye irritation study of the test item SIKA Hardener LPP 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, 2012). The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. A volume of 0.1 mL of the test item solution was used, as a single dose. The eyes of the test animals were not washed out after the application of test item. The eyes were examined at 1, 24, 48 and 72 hours after the application.

One hour after the treatment, slight conjunctival redness was observed in two animals. 72 hours after the treatment all animals were free of symptoms and the study was terminated. The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:

cornea opacity : 0.00, 0.00, 0.00

iris : 0.00, 0.00, 0.00

erythema : 0.00, 0.33, 0.00

chemosis : 0.00, 0.00, 0.00

discharge : 0.00, 0.00, 0.00

No systemic toxicity was observed on the day of the treatment and during the 72-hour observation period. The body weight of animals corresponded to their species and age. Signs of pain and distress as discharge were not observed. In conclusion, the test item SIKA Hardener LPP, applied to the rabbits’ eye mucosa, caused slight conjunctival irritant effect which was fully reversible within 72 hours. According to Regulation (EC) No 1272/2008, the test item has not been classified into any category.