Reaction product of Aminoguanidine bicarbonate and Tall Oil fatty acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08-12-2000-06-01-2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study performed according with the OECD guideline 405.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Remarks:

Statement of compliance with GLP guidelines

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

442-600-9

EC Name:

-

Molecular formula:

The substance is a UVCB for which it is not possible to provide a molecular formula

IUPAC Name:

(9E)-N-[(N'-hexadecanoyloctadecanehydrazido)methanimidoyl]octadec-9-enamide

Details on test material:

Name: HiTEC 7134
Colour: Brown
Physical state: Viscous liquid
Purity: 51%
Storage conditions: Ambiente temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Limited
- Age at study initiation: no data
- Weight at study initiation: 3263-3970 kg
- Housing: individually in cages suitable for animals of this strain
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18±3 °C
- Humidity: 30-70%
- Air changes: 15 changes/hour
- Photoperiod (hrs dark / hrs light): artificial 12 h light/12 h dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied : 0.1 ml

Duration of treatment / exposure:

-

Observation period (in vivo):

3 days.

Number of animals or in vitro replicates:

3 animals.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: na

SCORING SYSTEM: according with Draize scale

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

8

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 28, 72 hours

Score:

0.22

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

There were no significant signs of illness in any animals during the study. Instillation into the eye caused no initial pain (class 0 on a 0-5 scale). There were no corneal or iridial effects. Conjunctival effects consisted of slight redness in all animals for up to 1 day and a slight discharge in all animals approximately 1 hour after instillation. Additional signs of irritation comprised convoluted or erythematous eyeluds, and dried secretion around the periorbital skin. One animal still had convoluted eyelids at termination on day 3.

Other effects:

None reported.

Any other information on results incl. tables

Table 1 –Individual scores

Animal Number	Sex	Init. pain reaction	Irrigation Number	Elapsed Time	Cornea			Iris		Conjunctiva				Total score
					Opacity (A)	Area (B)	Score (AxBx5)	(C)	Score (Cx5)	Redness (D)	Chemosis (E)	Discharge (F)	Score (D+E+F)
114	F	None	N	1.1 hrs	0	0	0	0	0	1	0	1	4	4
				1 day	0	0	0	0	0	1	0	0	2	2
				2days	0	0	0	0	0	0	0	0	0	0
				3 days	0	0	0	0	0	0	0	0	0	0
115	F	None	N	1.1 hrs	0	0	0	0	0	1	0	1	4	4
				1 day	0	0	0	0	0	0	0	0	0	0
				2 days	0	0	0	0	0	0	0	0	0	0
				3 days	0	0	0	0	0	0	0	0	0	0
116	F	None	N	1.1 hrs	0	0	0	0	0	1	0	1	4	4
				1 day	0	0	0	0	0	1	0	0	2	2
				2days	0	0	0	0	0	0	0	0	0	0
				3 days	0	0	0	0	0	0	0	0	0	0

Table 2 –Mean scores

Irrigation N	Mean scores			Mean total Score (max 110)
	Cornea (max. 80)	Iris (max 10)	Conjunctiva (max 20)
1 hrs (3)	0.0	0.0	4.0	4.0
1 day (3)	0.0	0.0	1.3	1.3
2 days (3)	0.0	0.0	0.0	0.0
3 days (3)	0.0	0.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results, the total mean score was 3. Conjunctiva redness was observed in the 3 animals, with a score of 1. The clinical signs were fully reversible in 48 hours. According with the Reg (EC) 1272/2008, HiTEC 7134 does not fall into the category of an eye irritant.

Executive summary:

HiTEC 7134 (0.1ml) was instilled into one eye of each of three rabbits and an assessment of initial pain was made. The eyes were examined for up to 3 days, to assess the grade of ocular reaction.

Instillation into the eye caused no initial pain (class 0 on a 5 -0 scale). There were no corneal or iridial effects. Conjunctival effects consisted of slight redness in all animals for up to 1 day and a slight discharge in all animals approximately 1 hour after instillation. Additional signs of irritation comprised convoluted or erythematous eyelids. And dried secretion around periorbital skin. One animal still had convoluted eyelids at termination on day 3. Based on the results, the HiTEC 7134 is not a eye irritant.