Carbonic acid, compound with 2-aminoethanol (1:2)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was performed between 05 August 2010 and 23 August 2010.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

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

Reference substance name:

MEA-carbamate

IUPAC Name:

MEA-carbamate

Constituent 2

Reference substance name:

Carbonic acid, compound with 2-aminoethanol (1:2)

EC Number:

244-600-2

EC Name:

Carbonic acid, compound with 2-aminoethanol (1:2)

Cas Number:

21829-52-7

Molecular formula:

C2H7NO.1/2CH2O3

IUPAC Name:

carbonic acid - 2-aminoethanol (1:2)

Test material form:

liquid: viscous

Details on test material:

Sponsor's identification: MEA-carbamate
Description : pale amber coloured viscous liquid
Lot number : 1243-171
Date received : 22 December 2008
Expiry date : 22 December 2011
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: New Zealand White rabbits were supplied by an accredited supplier.
- Age at study initiation: Twelve to twenty weeks old.
- Weight at study initiation: Weight range of 2.0 to 3.5 kg.
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Certified Rabbit Diet.
- Water (e.g. ad libitum): Free access to mains drinking water and food (Certified Rabbit Diet) was allowed throughout the study.
- Acclimation period: Five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): The rate of air exchange was at least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): The 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:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
A volume of 0.1 ml of the test material, which was found to weigh approximately 66 mg (as measured by gently compacting the required volume into
an adapted syringe) was placed into the conjunctival sac of the right eye.

Duration of treatment / exposure:

7 Days

Observation period (in vivo):

7 Days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not applicable

SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
Any other ocular effects were also noted
Interpretation of Results:
The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of cornea involved). For each tissue the score was calculated as follows:
Score for conjunctivae = (A + B + C) x 2
Score for iris = D x 5
Score for cornea = (E x F) x 5

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: animal 69475

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: animal 69520

Time point:

24/48/72 h

Score:

1.67

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

chemosis score

Basis:

animal: animal 69475

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

animal: animal 69520

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal: animal 69475

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No effect noted

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal: animal 69520

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No effect noted

Results 7

Irritation parameter:

iris score

Basis:

animal: animal 69475

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effect noted

Results 8

Irritation parameter:

iris score

Basis:

animal: animal 69520

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effect noted

Irritant / corrosive response data:

No corneal effects were noted during the study.
Iridial inflammation was noted in both treated eyes one hour after treatment and at the 24 and 48 Hour observations.
Moderate conjunctival irritation was noted in both treated eyes one hour after treatment and at the 24 and 48-Hour observations with minimal
conjunctival irritation noted at the 72 Hour observation.
Both treated eyes appeared normal at the 7-Day observation.

Any other information on results incl. tables

              Individual Scores and Individual Total Scores for Ocular Irritation

Rabbit Number and Sex	69475Male					69520Male
	IPR= 3					IPR = 0+
Time After Treatment	1 Hour	24 Hours	48 Hours	72 Hours	7 Days		1 Hour	24 Hours	48 Hours	72 Hours	7 Days
CORNEA
E = Degree of Opacity	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
Score (E x F) x 5	0	0	0	0	0		0	0	0	0	0
IRIS
D	1	1	1	0	0		1	1	1	0	0
Score (D x 5)	5	5	5	0	0		5	5	5	0	0
CONJUNCTIVAE
A = Redness	2	2	2	1	0		2	2	2	1	0
B = Chemosis	2	2	1	0	0		2	2	1	0	0
C = Discharge	3	2	2	1	0		3	2	1	1	0
Score (A + B + C) x 2	14	12	10	4	0		14	12	8	4	0
Total Score	19	17	15	4	0		19	17	13	4	0

IPR= Initial pain reaction

+= One drop of local anaesthetic instilled into both eyes 1 to 2 minutes before treatment

The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC (based on the mean scores for each animal).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC.

Executive summary:

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)

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

Result. A single application of the test item to the non-irrigated eye of two rabbits produced iridial inflammation and moderate conjunctival irritation. Both treated eyes appeared normal at the 7-Day observation.

Conclusion. The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC.