Polyamide wax

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30th Agust 2005 to 8th September 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviation from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF guidelines (Japan)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Identification: EA-3098
Cas number: 55349-01-4
Desciption: white powder
Batch: P-32681
Purity: not indicated by the sponsor; treated as 100% pure
Storage: room temperature in the dark
Stability under storage conditions: Stable
Expiry: 6th June 2009

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles river Deutschland, Kisslegg, Germany
- Age at study initiation: At least 6 weeks old
- Weight at study initiation: At least 1 kg
- Housing: housed individually in labeled cages with perforated floors (Scanbur, Denmark, dimensions 56 x 44 x 27.5 cm).
- Diet: Approximately 100 g per day of standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany).
- Water: ad libitum access to tap water
- Acclimation period: at least five days prior to start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 +/- 3.0°C (actual range: 20.2 - 22.3°C)
- Humidity (%): 30 - 70% (actual range 40 - 77%)
- Air changes (per hr): approximately 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light followed by 12 hours darkness per day

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
Animals were treated by instillation of, on average 49.8 mg (range 49.4 - 50.1 mg) of the test substance (a volume of approximately 0.1 ml), in the conjunctival sac of one of the eyes.

Duration of treatment / exposure:

Single application for 72 hour exposure.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 males.

Details on study design:

pH MEASUREMENT:
pH determined as 8.4.

STUDY DESIGN:
The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner one week later, after considering the degree of eye irritation observed in the first animal.

TREATMENT:
Animals were treated by instillation of, on average, 49.8 mg (range 49.4 - 50.1 mg) of the test substance (a volume of approximately 0.1 ml), in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control.

Immediately after the 24-hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.

After the final observation, the animals were sacrificed by intra-venous injection of pentobarbital.

OBSERVATIONS:
Mortality/Viability: Twice daily
Toxicity: At least once daily
Body weight: Day of treatment (prior to installation) and at termination.
Irritation: The eyes of each animal were examned approximately 1, 24, 48 and 72 hours after instillation of the test substance. The irritation scores and a description of all other (local) effects were recorded.

The irritation was assessed according to the numercial Draize Scale for Scoring Occular Irritation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

(Degree of opacity)

Basis:

mean

Remarks:

Animal 752

Time point:

other: Mean of scores at 24, 48 & 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Results 2

Irritation parameter:

cornea opacity score

Remarks:

(Degree of opacity)

Basis:

mean

Remarks:

( Animal 741)

Time point:

other: Mean of scores at 24, 48 & 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Results 3

Irritation parameter:

cornea opacity score

Remarks:

(Degree of opacity)

Basis:

animal: (Animal 757)

Time point:

other: Mean of scores at 24, 48 & 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

(Animal 752)

Time point:

other: Mean of scores at 24, 48 & 72 hours

Score:

0

Max. score:

2

Reversibility:

other: no effects observed

Results 5

Irritation parameter:

iris score

Basis:

mean

Remarks:

(Animal 741)

Time point:

other: Mean of scores at 24, 48 & 72 hours

Score:

0

Max. score:

2

Reversibility:

other: no effects observed

Results 6

Irritation parameter:

iris score

Basis:

mean

Remarks:

(Animal 757)

Time point:

other: Mean of scores at 24, 48 & 72 hours

Score:

0

Max. score:

2

Reversibility:

other: no effectss observed

Results 7

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

(Animal 752)

Time point:

other: Mean of scores at 24, 48 & 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hrs

Remarks on result:

other: Score at 1 hr = 2, score at 24 hr = 2, score at 48 hr = 1, score at 72 hr = 0

Results 8

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

(Animal 741)

Time point:

other: Mean of scores at 24, 48 & 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hrs

Remarks on result:

other: Score at 1 hr = 2, score at 24 hr = 2, score at 48 hr = 1, score at 72 hr = 0

Results 9

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

(Animal 757)

Time point:

other: Mean of scores at 24, 48 & 72 hours

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 hrs

Remarks on result:

other: Score at 1 hr = 2, score at 24 hr = 1, score at 48 hr = 1, score at 72 hr = 0

Results 10

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(Animal 752)

Time point:

other: Mean of scores at 24, 48 & 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hrs

Remarks on result:

other: Score of 1 at 1 hr

Results 11

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(Animal 741)

Time point:

other: Mean of scores at 24, 58 & 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hrs

Remarks on result:

other: Score at 1 hr = 1, score at 24 hr = 1, score at 48 hr = 0

Results 12

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(Animal 757)

Time point:

other: Mean of scores at 24, 48 & 72 hrs

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hrs

Remarks on result:

other: Score of 1 at 1 hr

Irritant / corrosive response data:

Irritation (Table 1 - attached background material):
Instillation of approximately 50 mg of EA-3098 (a volume of approximately 0.1 ml) into one eye of each of three rabbits resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 72 hours.

No iridial irritation or corneal opacity was observed, and treatment of the eyes with 2% flurescein, 24 hours after the test substance instillation revealed no corneal epithelial damage.

There was no evidence of ocular corrosion.

Other effects:

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Remnants of the test substance were present in the eye on Day 1.

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

Instillation of approximately 50 mg of EA-3098 (a volume of approximately 0.1 ml) into one eye of each of three rabbits resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 72 hours.
No iridial irritation or corneal opacity was observed, and treatment of the eyes with 2% flurescein, 24 hours after the test substance instillation revealed no corneal epithelial damage.
EA-3098 does not have to be classified for eye irritation.

Executive summary:

An acute eye irritation/corrosion study was conducted on the material, EA-3098, according to the following guidelines:

OECD No. 405 (2002) "Acute Eye Irritation/Corrosion"

EC, Council Directive 67/548/EEC, Annex V, B5 (2004) "Acute Toxicity: Eye irritation / corrosion"

EPA, OPPTS 870.2400 (1998) "Acute Eye Irritation"

JMAFF guidelines (2000); including the most recent partial revisions.

Single samples of approximately 50 mg of EA-3098 (a volume of approximately 0.1 ml) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation.

Instillation of the test substance resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 72 hours.

Overall results calculated on the basis of the scores for each animal at 24, 48 and 72 hours were:

	Mean score 1	Mean score 2	Mean score 3	Max. value observed	Max. duration of any effect	Max. value at the end of the observation period
Redness	1.0	1.0	0.7	2	48 hours	0
Chemosis	0.0	0.3	0.0	1	24 hours	0
Cornea	0.0	0.0	0.0	0	-	0
Iris	0.0	0.0	0.0	0	-	0

Remnants of the test substance were present in the eye on Day 1.

Based on these results EA-3098 does not have to be classified as an eye irritant as it does not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation (CLP)