Epoxides C12-16 (even numbered), reaction product with ethylene glycol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 Sept 1997 - 26 Sept 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD) (test substance purity not specified).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted Feb 1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

adopted 29 Dec 1992

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C12-14-secondary, β-(2-hydroxyethoxy)

EC Number:

308-219-6

EC Name:

Alcohols, C12-14-secondary, β-(2-hydroxyethoxy)

Cas Number:

97926-05-1

IUPAC Name:

97926-05-1

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Epicol G24 G2, C12/14alpha-Epoxid, ringgeöffnet mit Glykol, SAT970397
- Physical state: colorless, transparent fluid
- Analytical purity: not specified
- Lot/batch No.: 10017020
- Expiration date of the lot/batch: 20.01.1998
- Storage condition of test material: room emperature in the darkness

Test animals / tissue source

Species:

rabbit

Strain:

other: SPF albino, Mol:Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Mollegaard Breeding and Research Center A/S, Lille Skensved
- Weight at study initiation: 2.4 - 2.5 kg
- Diet: pelleted complete rabbit diet, Altromin 2123, ad libitum
- Water: domestic quality drining water, acidified with hydrochloric acid to pH 2.5 to prevent microbial growth, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours
reading time points at 1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

onr single animal followed by two further animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with 20 mL 0.9 % sodium chloride after instillation of Fluorescein
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize Scoring System

TOOL USED TO ASSESS SCORE: fluorescein & UV-light

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #1 - #3

Time point:

other: mean over 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal#1 - #3

Time point:

other: mean over 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #1 - #3

Time point:

other: mean over 24, 48 and 72 hours

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #1 - #2

Time point:

other: mean over 24, 48 and 72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

One hour after application if the test article all animals showed slight redness of conjunctivae. One animal additionally showed slight swelling of the conjunctivae. After 24 and 48 hours all animals schowed slight redness of conjunctivae and only a slight swelling of conjunctivae was still visible. After 72 hours no eye reactions could be observed any more.

Other effects:

Discharge with moistening of lids and hairs, and considerable area around the eye was observed in the animal with swelling of the conjunctivae. Discharge with moistening of lids and hairs just adjacent to lids was observed in one of the other two animals, whereas the third animal only showed slight discharge.

Any other information on results incl. tables

Table1: Overview of individual scores

	Cornea	Iris	Conjunctiva
	opacity		Redness	Chemosis
1 h (animal 1)	0	0	1	1
24 h	0	0	1	1
48 h	0	0	1	0
72 h	0	0	0	0
mean score (24 - 72 h)	0	0	0.67	0.33
1 h (animal 2)	0	0	1	0
24 h	0	0	1	1
48 h	0	0	1	0
72 h	0	0	0	0
mean score (24 - 72 h)	0	0	0.67	0.33
1 h (animal 3)	0	0	1	0
24 h	0	0	1	0
48 h	0	0	1	0
72 h	0	0	0	0
mean score (24 - 72 h)	0	0	0.67	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

DSD: not classified
CLP: not classified