Reaction products of amines, dicoco alkyl and glycollic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-12-08 to 2006-01-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP, guideline study

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Remarks:

2005-11-21

Test material

Test material information

Constituent 1

Details on test material:

- Physical state: dark amber slightly viscous liquid
- Analytical purity: No data
- Stability under test conditions: undetermined
- Storage condition of test material: 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: David Percival Ltd., Moston, Sandbach, Cheshire UK
- Age at study initiation: 12 to 20 weeks
- Weight at study initiation: 2.0 to 3.5 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):at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light: 12 hours dark

IN-LIFE DATES: From: 2005-12-14 To: 2006-01-06

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye used as concurrent control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): applied as supplied

Duration of treatment / exposure:

Eye not washed after exposure (72 hours)

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed

SCORING SYSTEM: Draize, Kay and Calandra

TOOL USED TO ASSESS SCORE: ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

5.3

Max. score:

2

Reversibility:

fully reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 4

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

2

Reversibility:

fully reversible

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

1

Reversibility:

fully reversible

Irritant / corrosive response data:

No corneal or iridial effects were noted during the study.
Minimal to moderate conjunctival irritation was noted in all treatment eyes one hour after treatment with minimal conjunctival irritation noted in two treated eyes at the 24-hour observation.
One treated eye appeared normal at the 24-hour observation and the two remaining treated eyes appeared normal at the 48-hour observation.

Any other information on results incl. tables

Table 1: Individual scores

Rabbit number and sex	18 Male				89 Male				91 Male
Time after treatment	1 hr	24 hr	48 hr	72 hr	1 hr	24 hr	48 hr	72 hr	1 hr	24 hr	48 hr	72 hr
Cornea	0	0	0	0	0	0	0	0	0	0	0	0
Iris	0	0	0	0	0	0	0	0	0	0	0	0
Conjunctivae	1	0	0	0	2	1	0	0	1	1	0	0
Chemosis	0	0	0	0	1	1	0	0	1	1	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material does not meet the criteria for classification as an eye irritant as defined in the EU CLP Regulation (EC) No. 1272/2008 under the conditions of the study.

Executive summary:

Test Guidance

OECD Guideline No. 405 and EC Method B5

Method and materials

Available information indicated that the test material had the potential to produce severe effects in the rabbit eye. To confirm the initial assessment a Rabbit Enucleated Eye Test (REET) was performed prior to the in vivo study ( see 7.3.2 Supp eye irritation - in vitro Mullaney 2006). The results indicated that the test material was unlikely to cause severe ocular irritancy.

0.1 mL of the test material was applied as supplied to the non-irrigated eye of three albino New Zealand rabbits. Irritation and classification was recorded using the Draize and Kay and Calandra scales at 1, 24, 48 and 72 hour time points.

Results

Application of the test material produced minimal to moderate conjunctival irritation. One eye appeared normal at the 24 -hour observation and the remaining two treated eyes appeared normal at the 48 -hour observation.

Conclusion

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for eye irritation.