Sodium 2-hexyloxyethanolate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study according to OECD guideline 405 (acute eye irritation/corrosion) study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-hexyloxyethanol

EC Number:

203-951-1

EC Name:

2-hexyloxyethanol

Cas Number:

112-25-4

Molecular formula:

C8H18O2

IUPAC Name:

2-(hexyloxy)ethanol

Constituent 2

Reference substance name:

Hexylglycol (EGHE)

IUPAC Name:

Hexylglycol (EGHE)

Details on test material:

- Name of test material (as cited in study report): n-Hexlglykol; Substance No. 83/145
- Expiration date of the lot/batch: 05/85

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Firma Gaukler, Offenbach/Main
- Weight at study initiation: mean value males: 2,62 kg; mean value females: 2.67 kg
- Housing: individual, stainless steel wire mesh cages
- Diet: Ovator Solikanin 4 mm, Muskator-Werke, Düsseldorf, ca. 130 g/day
- Water: tap water ca. 250 ml/day
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 ml
- Concentration: undiluted

Duration of treatment / exposure:

unwashed (21 d)

Observation period (in vivo):

21 d

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM:
Criteria for assessment of ocular lesions:

Cornea*: opacity (op): Degree of density (area most dense taken for reading)
0 = No ulceration or opacity.
1 = Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible.
2 = Easily discernible translucent area, details of iris slightly obscured.
3 = Nacreous area, na details of iris visible, size of pupil barely discernible.
4 = Opaque cornea, iris not discernible through the opacity.

Area of cornea involved (ar):
1 ≥ 0 ; ≤ ¼
2 ≥ ¼ ; < ½
3 ≥ ½; < ¾
4 ≥ ¾

Conjunctivae*
redness (red): (Refers to palpebral and bulbar conjunctivae, cornea and iris)

0 = Blood vessels normal
1 = Some blood vessels definitely hyperaemic (injected)
2 = Diffuse, crimson colour, individual vessels not easily discernible.
3 = Diffuse beefy red.

Chemosis (sw): Lids and/or nictitating membranes the lids and hairs
just adjacent to
0 = No swelling.
1 = Any swelling above normal (includes nictitating membranes).
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half closed
4 = Swelling with lids more than half closed eye

Iris:*
0 = Normal
1 = Markedly deepened rugae, congestion, swelling, moderate circunicorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive).
2 = No reaction to light, haemorrhage, gross destruction (any or all of these).

Discharge (di):
0 = No discharge
1 = Any amount different from normal (does not include small amounts ob served in inner canthus of normal animals).
2 =Discharge with moistening of lids.
3 =Discharge with moistening of the lids and hairs, and considerable area around the eye

* Table according to the OECD guideline no. 405 (adopted February 24, 1987), EEC directive 92/69, L 383A, B. and EPA/OPPTS, 870.2400 (August 1998)

Calculation of primary irritation index:
Per animal and reading:
A = 5* (opacity)* (Area)
B = 5* (iris)
C = 2* (redness + swelling + discharge)

Individual irritation score (IIS):
IIS = A + B + C

Primary irritation score (PIS):
PIS = ∑(individual irritation scores of all treated animals after 24 h)+ ∑(individual irritation scores of all treated animals after 48h)+ ∑(individual irritation scores of all treated animals after 72 h) / N

with N= [3* (number of animals treated)]

Results and discussion

In vivo

Results

Irritation parameter:

other: primary irritation score

Basis:

mean

Max. score:

27

Reversibility:

not reversible

Irritant / corrosive response data:

details presented in the table below

Any other information on results incl. tables

Animal	1	2	3
Identification No	0377	0391	0397
Weight (kg)	2.62	2.72	2.62
Gender	male	female	female

Grading was done according to OECD guideline 405:

Readings	Animal	Cornea		Iris	Conjunctiva			Symptoms	Individual irritation score
		op	ar		red	sw	di
1h	1	0	0	1	2	2	2	PV	17
	2	0	0	0	2	2	3		14
	3	0	0	0	3	2	3		16
	Mean								16
24h	1	1	4	1	2	1	1	PV	35
	2	1	4	1	2	2	2	E/PV	37
	3	0	0	1	3	2	2		17
	Mean								30
48h	1	1	4	2	2	1	1	PV	38
	2	1	4	1	2	1	2	E/PV	35
	3	0	0	0	2	0	1	NA	6
	Mean								26
72h	1	1	4	2	2	1	1	PV	38
	2	1	4	1	2	0	2	E/PV	35
	3	0	0	0	2	0	0	NA	4
	Mean								26
8d	1	1	3	1	1	0	0	NA	22
	2	2	3	0	1	0	0	CV/NA/HF	32
	3	0	0	0	0	0	0	NA	0
	Mean								18
21d	1	1	2	0	1	0	0	CV/NA	12
	2	2	3	1	2	0	0	CV/NA	41
	3	0	0	0	0	0	0	NA	0
	Mean								18

Calculation: 245 / 9 = 27 (rounded in whole numbers)

Primary irritation score: 27

Abbriviations of symptoms:

CV: cornea vascularisation

E:   suppuration

HF: alopecia

NA: scar formation

PV: miosis

Applicant's summary and conclusion

Interpretation of results:

highly irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: based on iris irritation at 72 h reading and non-reversibility after 21 days

Conclusions:

EU-classification: severely irritating (R41)
GHS-classification: serious eye damage category 1

Executive summary:

The study was accomplished according to OECD guideline 405 (acute eye irritation / corrosion).

An amount of 0.1 ml test substance was instilled into the right eye of 3 rabbits; the left eye served as control. Effects were recorded 1 h, 1 d, 2 d, 3 d, 8 d, 15 d & 21 d after instillation.

Conclusion: The test substance is highly irritating to the eyes (EU-classification: severely irritating (R41), GHS-classification: serious eye damage category 1).