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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was performed between 10 September 2007 and 20 September 2007.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Reaction mass of N,N’-bis-(3-methoxypropyl)-C22(branched)-alkyldiamide and N,N’-bis-(3-methoxypropyl)-C17(branched)-alkyldiamide
EC Number:
940-953-8
Molecular formula:
not applicable UVCB
IUPAC Name:
Reaction mass of N,N’-bis-(3-methoxypropyl)-C22(branched)-alkyldiamide and N,N’-bis-(3-methoxypropyl)-C17(branched)-alkyldiamide
Test material form:
other: off white waxy solid block

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Male New Zealand White rabbits were supplied by Harlan UK Limited.
- Age at study initiation: Twelve to twenty weeks old.
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Free access to food (Certified Rabbit Diet) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water was allowed throughout the study.
- Acclimation period: At least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Set to achieve limits of 17 to 23°C.
- Humidity (%): Set to achieve limits of 30 to 70%.
- Air changes (per hr): The rate of air exchange was at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
A volume of 0.1 ml of the test item was placed into the conjunctival sac of the right eye.
Duration of treatment / exposure:
Single application with observation to 72 hours.
Observation period (in vivo):
72 hours.
Number of animals or in vitro replicates:
3
Details on study design:
MEASUREMENT OF pH:
The pH of the test material was determined prior to commencement of the study and found to be as follows:
10% w/w aqueous preparation of the test material: pH 6.9 immediately, pH 7.0 after 10 minutes.

PROCEDURE:
Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.

Initially, a single rabbit was treated. A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain reaction was made according to the six point scale shown in Appendix 1 (see attached background material).

After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.

SCORING:
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical Draize Scale for Scoring Ocular Irritation (see Appendix 2 - attached background material).

Any other ocular effects were also noted.

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(66593 Male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No corneal effects noted
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(66602 Male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No corneal effects noted
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(66604 Male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No corneal effects noted
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(66593 Male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(66602 Male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: No iridial inflammation
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(66604 Male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: No iridial inflammation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(66593 Male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(66602 Male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(66604 Male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(66593 Male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(66602 Male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(66604 Male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
No corneal effects were noted.

Iridial inflammation was noted in one treated eye one hour after treatment.

Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted in all treated eyes at the 24-hour observation.

All treated eyes appeared normal at the 48-hour observation.

Other effects:
The maximum group mean scores was 9.0 at 1 hour.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a maximum group mean score of 9.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. According to the REGULATION (EC) No 1272/2008 (CLP) the test item is not classified for eye irritation.
Executive summary:

Introduction.

The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

- OECD Guidelines for the Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 April 2002)

- Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 2004/73/EC

Result.

A single application of the test material to the non-irrigated eye of three rabbits produced iridial inflammation and minimal to moderate conjunctival irritation. All treated eyes appeared normal at the 48-hour observation.

Conclusion.

The test material produced a maximum group mean score of 9.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. According to the REGULATION (EC) No 1272/2008 (CLP) the test item is not classified for eye irritation.