AAA reaction product

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-07-01 to 2003-09-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study performed in accordance to guideline with no deviations

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

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

Principles of method if other than guideline:

NA

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): DEA/ACID ANHYDRIDE REACTION PRODUCT

- Physical state: highly viscous amber liquid

- Composition of test material, percentage of components:
Monomers: <17-35% (9-16% diethanolamine; 2-8% tetrahydrophthalic acid; 5-11% trimellitic acid; <0.1% tetrahydrophthalic anhydride; <0.8% trimellitic anhydride)
Dimers/trimers: <24-45%
Polymers: <10-25%
Not removable water: 5-15%

- Lot/batch No.: 200501.UN2810

- Expiration date of the lot/batch: september 2003

- Stability under test conditions: stable under storage condition

- Storage condition of test material: in the refrigerator in the original container away from direct sunlight

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 Rabbit, SPF
- Age at study initiation: 10 - 11 weeks (male), 10 - 11 weeks (females)
- Weight at study initiation: 1966 g (male), 2187 g (female), 2112 g (female)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks were provided.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 28/03).
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: 2003-06-12 to 2003-06-16

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): utomatically controlled light cycle of 12 hours light and 12 hours dark. Music was played during the daytime light period.

IN-LIFE DATES: 2003-06-12 to 2003-06-20

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

VEHICLE
- Amount(s) applied (volume or weight with unit): NA
- Concentration (if solution): NA
- Lot/batch no. (if required): NA
- Purity: NA

Duration of treatment / exposure:

0.1 mL installed into the left conjuctival sac of the left eye of each of the animals. The right eye remained untreated and served as reference control.

Observation period (in vivo):

1, 24, 48, 72 hours and after 7days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: The test substance was not removed after installation

SCORING SYSTEM: The ocular reaction (corneal opacity, area, iris, conjunctivae (redness and chemosis) and schlera) was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 approximately 1, 24, 48, 72 hours and 7 days after application.

TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp (Roth Ag, Ch-4153 Reinach/Switzerland)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0.67

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0.33

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Results 4

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Max. score:

1

Remarks on result:

other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 7

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 11

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 12

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 13

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Irritant / corrosive response data:

The application of AAA reaction product to the eye resulted in slight swelling of the conjunctivae (chemosis) in 1 animal at the 1 hour reading. Slight reddening of the conjunctivae was observed in all animals at the 1- and 24-hour reading. Slight reddening was still evident in two animals 48 hours after treatment and persisted in on animal up to the 72-hour examination. Slight reddening of the schlerae was visible in one animal 1 hour after treatment. No ocular discharge was observed in any animal. No abnormal findings were observed in the treated eye of any animal 7 days after treatment, the end of the observation period for all animals. No staining or corrosion was observed.

Other effects:

The bodyweights of all rabbits were considered to be within the normal range of variability.


The bodyweights of all rabbits were considered to be within
the normal range of variability.

Any other information on results incl. tables

Overall assessment of irritation scores in accordance to EEC grading system

Corneal opacity: Not irritating

Iris: Not irritating

Conjunctivae - Redness: Not irritating

Conjunctivae - Chemosis: Not irritating

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The eye irritation potential of AAA reaction product to the rabbit eye was evaluated in accordance to OECD 405. AAA reaction product did not induce significant or irreversible damage to the rabbit eye and is therefore considered to be "not irritant" to the rabbit eye. No classification is applied.

Executive summary:

The primary eye irritation potential of AAA reaction product was evaluated in accordance to OECD 405. AAA reaction product was applied by installation of 0.1 mL into the left eye of each of 3 rabbits, the right eye serving as control. Scoring of irritation was performed after 1, 24, 48, 72 hours and after 7 days.

The individual mean scores for corneal opacity and iris were 0.00 for all 3 animals. The individual mean scores for conjuctivae were 0.67, 0.33 1.00 for reddening and for all 3 animals 0.00 for chemosis, respectively.

The instillation of AAA reaction product into the eye resulted in mild , early-onset and transient ocluar changes

No ocular discharge was observed in any animal. No abnormal findings were observed in the treated eye of any animal 7 days after treatment, the end of the observation period for all animals. No staining or corrosion was observed. Further, no other clinical signs were observed.

AAA reaction product did not induce significant or irreversible damage to the rabbit eye and is therefore considered to be "not irritant" to the rabbit eye. No classification is applied.