Octadecanoic acid, reaction products with diethylenetriamine and urea, acetates

Eye irritation

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Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

other: waxy solid

Details on test material:

None

Specific details on test material used for the study:

Identification: Sapamine CSN
Batch: 0024141800
Storage Conditions: room 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: Harlan Laboratories UK
- Age at study initiation: 12 to 20 weeks
- Weight at study initiation: 2.30 to 2.49 kg
- Housing: Individually housed in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 01st July 2013 To: 18th July 2013

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (approximately 80 mg)

Duration of treatment / exposure:

72 hrs

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 male rabbits

Details on study design:

SCORING SYSTEM: Draize scale for scoring ocular irritation

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No scores at any time point.

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.11

Max. score:

2

Reversibility:

fully reversible within: 48h

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.66

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.77

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

All animals showed expected gain in body weight during the study.

Other effects:

Moderate conjuctival irritation was noted in all treated eyes one hour after treatment. Moderate conjuctival irritation was noted in one treated eye and minimal conjuctival irritation was noted in two treated eyes at the 24 and 48 hour observations. Minimum conjuctival irritation was noted in one treated eye at the 72 hour observation.

Any other information on results incl. tables

Individual Scores and Individual Total Scores for Ocular Irritation

Rabbit Number and Sex	73300 Male					73339 Male				73340 Male
	IPR=O					IPR=O				IPR=O
Time After Treatment	1 Hour	24 Hours	48 Hours	72 Hours	7 Days	1 Hour	24 Hours	48 Hours	72 Hours	1 Hour	24 Hours	48 Hours	72 Hours
CORNEA
E = Degree of Opacity	0	0	0	0	0	0	0	0	0	0	0	0	0
F = Area of Cornea Involved	0	0	0	0	0	0	0	0	0	0	0	0	0
Score (E x F) x 5	0	0	0	0	0	0	0	0	0	0	0	0	0
IRIS
D	1	1	0	0	0	0	0	0	0	1	0	0	0
Score (D x 5)	5	5	0	0	0	0	0	0	0	5	0	0	0
CONJUNCTIVAE
A=Redness	2	2	2	1	0	2	2	1	0	2	1	1	0
B = Chemosis	2	1	1	1	0	2	1	1	0	2	1	1	0
C = Discharge	2	1	1	0	0	1	0	0	0	1	1	0	0
Score (A+ B +C)x 2	12	8	8	4	0	10	6	4	0	10	6	4	0
Total Score	17	13	8	4	0	10	6	4	0	15	6	4	0

IPR=    Initial pain reaction

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item does not meet the criteria for classification as an eye irritant according to the GHS of Classification and Labelling of Chemicals.

Executive summary:

The study was performed to assess the irritancy potential of the test item to the eye of New Zealand white Rabbit. The study was conducted according to OECD guideline 405 and B.5 Method of EC in accordance with GLP.

A single application of the test item to the non-irritated eyes of 3 male rabbits produced iridial inflammation and moderate conjunctival irritation. Two treated eyes appeared normal at the 72 hour observation and one treated eye appeared normal at the 7 day observation.

The mean 24/48/72 hr score was as follows;

Cornea opacity: 0

Iris: 0.11

Conjuctivae redness: 1.66

Chemosis: 0.77

Moderate conjuctival irritation was noted in all treated eyes one hour after treatment. Moderate conjuctival irritation was noted in one treated eye and minimal conjuctival irritation was noted in two treated eyes at the 24 and 48 hour observations. Minimum conjuctival irritation was noted in one treated eye at the 72 hour observation.

Based on the findings of the study, the test item does not meet the criteria for classification as an eye irritant according to the GHS of Classification and Labelling of Chemicals.