C8-18 alkylampho(di)propionates

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 15, 1988 - June 29, 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study has been performed similar to OECD 405 (1981) and according to GLP principles. However, as the observation period stopped on day 7, the reversibility could not be fully assessed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: modification of the Code of Federal Regulations 1500-42 (1985)

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(1981)

Deviations:

yes

Remarks:

the observation period of only 7 days instead of up to 21 days was not sufficient to evaluate the reversibility or irreversibility of the effects observed, and the ocular lesions were not scored 1 hour after installation

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

other: aqueous solution

Details on test material:

- Physical state: Aqueous solution
- Appearance: No data
- Composition of test material, percentage of components: see section confidential details on test material

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Boyertown, PA, USA
- Age at study initiation: no data (but reported to be young adults)
- Weight at study initiation: 2.30 - 2.62 kg
- Housing: suspended wire mesh cages
- Diet: Purina rabbit pellets (ad libitum)
- Water: ad libitum
- Acclimation period: minimum period of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 72 ± 5 degrees F (22.2 ± 5 °C)
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark/12 hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated left eye served as the control

Amount / concentration applied:

TEST MATERIAL (applied as such)
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

Not applicable (the eyes were not rinsed)

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 (2 females and 1 male)

Details on study design:

REMOVAL OF TEST SUBSTANCE: not applicable
SCORING SYSTEM: similar to OECD 405
TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 3d

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 2d

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 4d

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 4d

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not reversible

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.66

Max. score:

3

Reversibility:

not fully reversible within: 7d

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.66

Max. score:

4

Reversibility:

not reversible

Results 9

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 2d

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7d

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.66

Max. score:

3

Reversibility:

fully reversible within: 7d

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7d

Irritant / corrosive response data:

See section "Any other information on results incl. tables"

Other effects:

See section "Any other information on results incl. tables"

Any other information on results incl. tables

Animal number and sex	Parameter	Hours after instillation			Days after instillation
		24	48	72	4	7
7907 Male	Cornea (opacity)	1	1	0	0	0
	Cornea (area)	1	1	0	0	0
	Iris	1	0	0	0	0
	Conjunctivae (redness)	2	1	1	0	0
	Conjunctivae (chemosis)	2	1	1	0	0
	Conjunctivae (discharge)	2	1	0	0	0
7908 Female	Cornea (opacity)	2	2	2	2	2
	Cornea (area)	not scored
	Iris	1	1	1	0	1
	Conjunctivae (redness)	3	3	2	1	2
	Conjunctivae (chemosis)	2	2	1	1	2
	Conjunctivae (discharge)	2	2	1	1	2
7909 Female	Cornea (opacity)	2	2	2	1	0
	Cornea (area)	2	2	1	1	0
	Iris	1	0	0	0	0
	Conjunctivae (redness)	2	2	1	1	0
	Conjunctivae (chemosis)	2	1	1	1	0
	Conjunctivae (discharge)	2	2	1	0	0

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study, performed similar to OECD 405 (1981) and according to GLP principles, the substance (solid content 38-40%) is classified as causing serious eye damage (Category 1) according to the criteria of the CLP Regulation.

Executive summary:

The substance was tested for acute ocular irritation in 2 females and 1 male New-Zealand White rabbits, similar to OECD 405 and according to GLP principles. The test material (solid content: 38-40%), was instillated as such in a single dose of 0.1 ml into the conjunctival sac of the right eye of each animal. The left eye remained untreated and served as a control. The eyes were not rinsed. Ocular examinations were performed 24, 48, 72 hours and 4 and 7 days after the instillation. Grade 2 corneal opacity was observed in 2 animals at 24 hours, lasting up to 72 hours in 1 animal. It persisted in the other animal throughout the 7 day observation period. In this same animal, conjunctival redness (grade 1, 2 and 3), conjunctival chemosis (grade 1 and 2) and iris inflammation (grade 1) persisted also throughout the observation period. In the other 2 animals the effects (grade 1 and 2) reversed within the observation period. As reversibility could not be observed in 1 animal in this study, the substance should be classified according to Regulation EC 1272/2008 with category 1, H318 "Causes serious eye damage".