tetradecylalcohol ethoxylate methyloxirane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

between 6 May 1999 and 13 May 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 24 February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tetradecanol ethoxylated (EO<2.5), reaction products with epichlorohydrin

IUPAC Name:

Tetradecanol ethoxylated (EO<2.5), reaction products with epichlorohydrin

Test material form:

liquid

Details on test material:

Sponsor’s identification : BEROL 1872 (C14 Alkyl polyethoxy glycidylether)
Batch number : 996185
Date received : 15 April 1999
Description : pale yellow slightly turbid liquid
Storage conditions : room temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: twelve to sixteen weeks old.
- Weight at study initiation: 2.75 to 3.00 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 6 May 1999 and 13 May 1999

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

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

Duration of treatment / exposure:

No flushing of eyes after instillation

Observation period (in vivo):

72 hours

Duration of post- treatment incubation (in vitro):

n.a.

Number of animals or in vitro replicates:

One initial and two additional animals

Details on study design:

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

SCORING SYSTEM: According to Draize scale for
1. CONJUNCTIVAE: A. Redness (0-30); B. Chemosis (0-4); C. Discharge (0-3)
THE TOTAL SCORE = (A + B + C) x 2 MAXIMUM TOTAL = 20
2. IRIS: D. Iris values (0-2)
THE TOTAL SCORE = D x 5 MAXIMUM TOTAL = 10
3. CORNEA: E. Degree of Opacity (0-4); F. Area of Cornea Involved (0-4)
THE TOTAL SCORE = (E x F) x 5 MAXIMUM TOTAL = 80
Maximum total score (1 + 2 +3 ) = 110

Additional scoring: MODIFIED KAY AND CALANDRA INTERPRETATION OF EYE IRRITATION TEST

TOOL USED TO ASSESS SCORE: standard ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: All

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

animal: All

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment.
Moderate conjunctival irritation persisted in two treated eyes with minimal conjunctival irritation in the remaining treated eye at the 24-hour observation.
Minimal conjunctival redness was noted in two treated eyes at the 48-hour observation.
One treated eye appeared normal at the 48-hour observation and the two remaining treated eyes appeared normal at the 72-hour observation.

Any other information on results incl. tables

Table: Individual scores and individual total scores for occular irritation

Rabbit number and sex	#1 male				#2 male				#3 male
Time after treatment	1 hr	24 hr	48 hr	72 hr	1 hr	24 hr	48 hr	72 hr	1 hr	24 hr	48 hr	72 hr
Cornea
E=degree opacity	0	0	0	0	0	0	0	0	0	0	0	0
F=Area opacity	0	0	0	0	0	0	0	0	0	0	0	0
Score (ExF) x 5	0	0	0	0	0	0	0	0	0	0	0	0
IRIS
D	0	0	0	0	0	0	0	0	0	0	0	0
Score (D x 5)	0	0	0	0	0	0	0	0	0	0	0	0
CONJUNCTIVA
A=Redness	2	2	1	0	2	2	1	0	2	1	0	0
B=Chemosis	1	1	0	0	2	1	0	0	1	1	0	0
C=Discharge	2	1	0	0	2	1	0	0	2	1	0	0
Score (A+B+C) x 2	10	8	2	0	12	8	2	0	10	6	0	0
Total Score	10	8	2	0	12	8	2	0	10	6	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material did not produce positive criteria in any rabbit according to GHS criteria.

Executive summary:

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987) and Method 85 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

 

A single instillation of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. One treated eye appeared normal at the 48-hour observation and the remaining treated eyes appeared normal at the 72-hour observation.

No corneal or iridial effects were noted during the study.

Mean score at 24/48/72 hr for Conjunctival redness for the 3 animals were 1, 1 and 0.3, and for chemosis 0.3, 0.3 and 0.3 respectively.

As none of the mean scores were ≥ 2, the test material did not produce positive criteria for eye irritation in any of the rabbit according to GHS criteria.