Poly(oxy-1,2-ethanediyl), α-butyl-ω-hydroxy-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

9004-77-7

Cas Number:

9004-77-7

IUPAC Name:

9004-77-7

Constituent 2

Reference substance name:

Poly(oxy-1,2-ethanediyl), α-butyl-ω-hydroxy-

EC Number:

500-012-0

EC Name:

Poly(oxy-1,2-ethanediyl), α-butyl-ω-hydroxy-

Cas Number:

9004-77-7

Molecular formula:

(C2H4O)nC4H10O

IUPAC Name:

2-butoxyethan-1-ol

Constituent 3

Reference substance name:

Poly(oxy-1,2-ethanediyl), α-butyl-ω-hydroxy

IUPAC Name:

Poly(oxy-1,2-ethanediyl), α-butyl-ω-hydroxy

Details on test material:

- Name of test material (as cited in study report): BP DCP 208 Proprietary polyalkalyene glycol formulation
- Physical state: brown liquid
- Lot/batch No.: BP DCP208/HRC/June 93
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Animals were indentified using unique numbers within the study which were written with black indelible marker-pen on the inner surface of the ear and on a cage label.

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.84 – 2.94 kg
- Housing: Animals were individually housed in suspended metal cages
- Diet: RABMA Rabbit Diet, Special Diet Services Ltd., Witham, Essex, U.K.) ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 – 23°C
- Humidity: 58-69%
- Air changes: 15 changes/hr
- Photoperiod: 12 hours light/12 hours dark

IN-LIFE DATES: From: 2 August 1993 To: 18 August 1993

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- For the purpose of this study the test material was used as supplied.
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

One rabbit was initially treated.  A volume of 0.1 ml of the test material was instilled into the conjucntival sac of the right eye, formed by gently pulling the lower lid away from the eyeball.  The upper and lower eyelids were held together for about one second immediately after instillations, to prevent loss of the test material, and then released.  The left eye remained untreated and was used for control purposes.  Immediately after administration of the test material, an assessment of the initial pain reaction was made.

Observation period (in vivo):

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48, and 72 hours following treatment, according to the numerical evaluation given in Appendix I, (from Draize J.H. 1959, Association of Food and Drug Officials of the United States, Austin, Texas, “The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics”).

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

maximum mean total score (MMTS)

Time point:

72 h

Score:

43.5

Max. score:

110

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1.12

Max. score:

4

Reversibility:

fully reversible within: 14 days, based on 2 animals (3rd terminated day 2)

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 14 days, based on 2 animals (3rd terminated day 2)

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days, based on 2 animals (3rd terminated day 2)

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days, based on 2 animals (3rd terminated day 2)

Irritant / corrosive response data:

Dulling of the normal luster of the corneal surface was noted in all treated eyes one hour after treatment. Areas of diffuse corneal opacity were noted in all treated eyes at the 24 and 48- hour observations. Areas of diffuse or translucent corneal opacity were noted in two treated eyes at the 72-hour observation. Diffuse corneal opacity was noted in one treated eye at the 7-day observation. Vascularisation of the cornea was also noted in this treated eye at the 7-day observation.

Iridial inflammation was noted in all treated eyes on hour after treatment, at the 24 and 48-hour observation and in two treated eyes at the 72-hour observation. No other iridial effects were noted.

Moderate conjunctival irritation was noted in all treated eyes on hour after treatment and at the 24 and 48-hour observations.  Moderate conjunctival irritation was noted in two treated eyes at the 72-hour observation with minimal conjunctival irritation at the 7-day observation.

Two treated eyes appeared normal fourteen days after treatment.

Any other information on results incl. tables

On the basis of the iritis and chemosis effects seen, this substance meeets the criteria for classification as an eye irritant (R36) under EU directive 67/548.

On the basis of the iritis, corneal , conjunctival and chemosis effects seen, this substance meeets the criteria for classification as an eye irritant (H319) under EU regulation 1272/2008.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material produced a maximum group mean score of 43.5 and was classified as at least a moderate irritant (Class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

The test material was also classified as irritant according to EEC labelling regulations.

Executive summary:

In a guideline (OECD 405) and GLP study, and substance meeting the description "Poly(oxy-1,2,-ethanediyl), α-butyl, ω-hydroxyl" was found to cause significant but reversible irritation to the rabbit eye. The substance met the criteria for classification as an eye irritant category 2 (H319).